Pfizer
Nervous system symptom reports
Female, 60 - 75 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 60 | 2020-12-31 | flushing |
I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Ligh...
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I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.
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| 60 | 2021-01-01 | feeling of body temperature change, tremor |
Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling h...
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Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold
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| 60 | 2021-01-03 | feeling cold |
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ...
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* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
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| 60 | 2021-01-03 | weakness | Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours |
| 60 | 2021-01-03 | pain in extremity | Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days. |
| 60 | 2021-01-04 | facial paralysis, slurring |
Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her hist...
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Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.
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| 60 | 2021-01-04 | muscle spasms, weakness |
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation...
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Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
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| 60 | 2021-01-04 | tingling, flushing |
Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a littl...
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Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.
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| 60 | 2021-01-04 | flushing |
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a...
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Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
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| 60 | 2021-01-04 | muscle spasms |
Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm c...
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Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.
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| 60 | 2021-01-04 | feeling cold |
generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run do...
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generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 60 | 2021-01-04 | hot flush, weakness | tired Chills Muscle aches Throat irritation weakness no energy hot flashes |
| 60 | 2021-01-05 | tingling | Dizziness, tingling, possible anxiety attack |
| 60 | 2021-01-05 | pain in extremity |
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b...
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Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
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| 60 | 2021-01-05 | pain in extremity |
On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she fel...
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On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.
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| 60 | 2021-01-05 | flushing |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021 Date: 1/6/2021 MRN: 3274958 Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020 PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Objective Vitals Vitals: 01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38 Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm APRN Electronically Signed 1/6/2021 12:45 PM
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| 60 | 2021-01-05 | pain in extremity | Sore arm lasting 24-48 hours. Ibuprofen |
| 60 | 2021-01-05 | tingling | Tingling of toes and finger on the on side of body vaccine occurred, light headed, HEAD ACHE |
| 60 | 2021-01-05 | burning sensation, flushing |
dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to...
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dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-06 | cold extremities, flushing, tingling, numbness |
30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some a...
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30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.
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| 60 | 2021-01-06 | tremor |
Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self ...
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Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.
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| 60 | 2021-01-07 | numbness, tingling |
Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, mi...
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Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, migrated to right pinkie finger with one hours. Acetaminophen
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| 60 | 2021-01-07 | seizure like phenomena | Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night |
| 60 | 2021-01-07 | tingling, flushing |
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD...
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Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
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| 60 | 2021-01-07 | muscle spasms | Mild shortness of breath Severe bil lower extremity muscle spasms/cramps |
| 60 | 2021-01-07 | difficulty speaking |
Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient compl...
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Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.
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| 60 | 2021-01-07 | pain in extremity |
arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on he...
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arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."
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| 60 | 2021-01-09 | weakness |
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve...
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Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
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| 60 | 2021-01-09 | migraine |
HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35...
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HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN
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| 60 | 2021-01-10 | feeling hot |
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to t...
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1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
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| 60 | 2021-01-10 | feeling cold |
COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th ...
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COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.
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| 60 | 2021-01-10 | feeling hot |
Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms...
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Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.
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| 60 | 2021-01-10 | inability to speak |
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache...
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Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 60 | 2021-01-10 | discomfort, tremor |
Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for...
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Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for past 15 days. Due for second dose afraid to take it.
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| 60 | 2021-01-10 | pain in extremity, weakness, feeling hot |
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ...
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She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
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| 60 | 2021-01-10 | weakness |
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre...
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four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
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| 60 | 2021-01-10 | weakness | nausea,weakness,chills , fever , muscle and joint pain , no appetite |
| 60 | 2021-01-11 | pain in extremity |
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheez...
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Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-01-11 | cold sweat |
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an...
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Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
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| 60 | 2021-01-11 | tremor | TEMP 99 AFTER TYLENOL s shaking chills |
| 60 | 2021-01-11 | pain in extremity |
developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tyleno...
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developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad
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| 60 | 2021-01-11 | flushing |
the patient began to experience dizziness and flushing; the patient began to experience dizziness an...
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the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 60 | 2021-01-12 | tingling |
At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following we...
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At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.
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| 60 | 2021-01-12 | pain in extremity |
Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous r...
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Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.
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| 60 | 2021-01-12 | difficulty speaking |
Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started hav...
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Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.
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| 60 | 2021-01-12 | migraine |
Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; ...
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Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.
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| 60 | 2021-01-12 | pain in extremity |
The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low ene...
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The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low energy for about three weeks and I'm just now feeling better. Around the 26th my lymph nodes swelled up (three of them) . I called my PCP, he told me to take Tylenol is painful and to put warm compress if they were uncomfortable. They are still there, they don't hurt or painful.
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| 60 | 2021-01-13 | tingling |
Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained ...
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Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.
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| 60 | 2021-01-13 | muscle spasms |
Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches ...
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Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches and cramping all over.
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| 60 | 2021-01-13 | feeling hot, cold extremities, tingling, pain in extremity, flushing |
flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness...
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flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.
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| 60 | 2021-01-14 | pain in extremity, muscle spasms |
1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heavine...
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1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.
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| 60 | 2021-01-14 | discomfort |
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,...
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Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
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| 60 | 2021-01-14 | pain in extremity |
I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in...
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I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.
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| 60 | 2021-01-14 | feeling hot |
Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection...
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Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.
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| 60 | 2021-01-14 | pain in extremity |
left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weake...
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left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.
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| 60 | 2021-01-14 | weakness |
reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports wea...
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reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,
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| 60 | 2021-01-15 | pain in extremity | Arm and joint pain, itching, rash |
| 60 | 2021-01-15 | tingling, difficulty speaking |
I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor ...
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I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.
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| 60 | 2021-01-15 | numbness, pain in extremity |
Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thy...
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Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.
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| 60 | 2021-01-16 | pain in extremity, flushing |
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ...
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Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
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| 60 | 2021-01-16 | tingling, numbness |
Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vac...
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Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vaccine I had R facial numbness from maxillary to ear and lower jaw. Within 6 1/2 hrs from the vaccine, I had R lateral calf numbness. Within 8 hrs of the vaccine, I had R hand and arm numbness, R side of mouth and tip of tongue numb, R orbital swelling, scratchy R eye, maxillary tenderness. Advil was taken 9 1/2 hrs after the vaccine. Symptoms improved by next am, and gone by 24 hrs post vaccine.
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| 60 | 2021-01-17 | cold sweat | Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment. |
| 60 | 2021-01-17 | muscle spasms |
Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to l...
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Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to lessen to every couple of hours day and night
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| 60 | 2021-01-17 | pain in extremity |
SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT M...
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SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.
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| 60 | 2021-01-17 | numbness |
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo...
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limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
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| 60 | 2021-01-18 | flushing |
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and fo...
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Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening
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| 60 | 2021-01-18 | tremor |
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head...
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Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
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| 60 | 2021-01-18 | slurring |
Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupil...
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Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.
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| 60 | 2021-01-18 | tingling |
began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and ras...
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began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face
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| 60 | 2021-01-18 | feeling hot |
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt rea...
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fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
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| 60 | 2021-01-19 | bell's palsy |
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. To...
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Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
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| 60 | 2021-01-19 | cold sweat |
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ...
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Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
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| 60 | 2021-01-19 | weakness, feeling hot |
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra...
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Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
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| 60 | 2021-01-19 | flushing | chills, headache, body aches, loss of taste, flush, red eyes, extreme fatigue |
| 60 | 2021-01-20 | pain in extremity | Sore arm vomiting diarrhea muscle pain pain in the neck to the shoulders |
| 60 | 2021-01-20 | hot flush, weakness |
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i...
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Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
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| 60 | 2021-01-20 | pain in extremity |
received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working after...
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received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.
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| 60 | 2021-01-20 | pain in extremity |
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co...
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taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
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| 60 | 2021-01-21 | feeling hot |
INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of...
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INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever
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| 60 | 2021-01-21 | tingling |
Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her r...
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Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.
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| 60 | 2021-01-21 | pain in extremity |
Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs afte...
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Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.
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| 60 | 2021-01-23 | tremor | developed muscle tremors, ataxia, unable to walk, nausea |
| 60 | 2021-01-24 | feeling hot, tremor |
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l...
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12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
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| 60 | 2021-01-24 | feeling cold |
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s...
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Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
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| 60 | 2021-01-24 | muscle spasms, tremor |
Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; T...
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Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-01-24 | burning sensation, weakness, pain in extremity |
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate...
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Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-25 | pain in extremity |
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz...
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Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
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| 60 | 2021-01-25 | slurring |
Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/...
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Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92
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| 60 | 2021-01-25 | slurring |
The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, s...
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The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.
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| 60 | 2021-01-25 | pain in extremity |
sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female p...
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sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Dec2020 for COVID-19 immunization. Medical history included asthma; hypertension; acid reflux; food allergies; known allergies to peanut, shell fish, IVP dye, penicillin and tree nuts. Patient also had known allergies to erythromycin and ceftriaxone (ROCEPHIN). Concomitant medication was not reported. There was no other vaccine in four weeks. On the first dose of 19Dec2020 just a sore arm (date unspecified). The outcome of event was unknown. Information on lot/batch no. has been requested.
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| 60 | 2021-01-26 | muscle spasms, numbness |
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin...
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C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
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| 60 | 2021-01-26 | pain in extremity |
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c...
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Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
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| 60 | 2021-01-26 | pain in extremity |
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ...
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First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
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| 60 | 2021-01-26 | pain in extremity |
There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose o...
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There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.
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| 60 | 2021-01-27 | pain in extremity |
Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes...
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Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.
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| 60 | 2021-01-27 | cold sweat | Red, warm rash around injection site cold sweat, chills, and swelling to Left arm |
| 60 | 2021-01-27 | numbness, pain in extremity |
Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritat...
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Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.
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| 60 | 2021-01-27 | pain in extremity |
arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, ...
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arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
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| 60 | 2021-01-28 | hot flush, tenderness |
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT C...
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FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
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| 60 | 2021-01-28 | tremor, weakness |
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo...
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Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
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| 60 | 2021-01-28 | pain in extremity, weakness, migraine |
day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling cru...
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day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
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| 60 | 2021-01-29 | feeling cold |
Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt ...
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Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.
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| 60 | 2021-01-31 | tingling |
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days...
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6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
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| 60 | 2021-02-01 | flushing |
10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is ...
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10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is abnormal for me because my normal is 96.5-97. I called my employer and had COVID test on 1-2-21 negative. Employer instructed me to go to get flu A and B test and strep test which were all negative on 1-3-21. On 1-5-21 had second covid test that was negative. On 1-6-21 video visit at PCP since I wanted to be released to go back to work. Had CXR(negative) and started doxycyline 100mg for possible sinus infection. Flushing sensation stopped on 1-9-21. No flushing sensation until 1-22-21(10 days after 2nd vaccine) but temp 98.5 at highest and I continue to have today. I continued to work through this second episode since I believe it was my body's reaction to the virus.
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| 60 | 2021-02-01 | pain in extremity |
Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she ...
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Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.
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| 60 | 2021-02-01 | pain in extremity |
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s...
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Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
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| 60 | 2021-02-01 | weakness |
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ...
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Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
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| 60 | 2021-02-02 | migraine |
Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to c...
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Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!
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| 60 | 2021-02-03 | weakness, pain in extremity |
Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness co...
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Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness continue even after 1 month.
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| 60 | 2021-02-03 | feeling cold |
chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a c...
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chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
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| 60 | 2021-02-03 | flushing |
light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healt...
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light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.
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| 60 | 2021-02-03 | slurring |
slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupil...
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slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.
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| 60 | 2021-02-04 | tremor |
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that da...
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1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'
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| 60 | 2021-02-04 | pain in extremity |
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o...
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12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
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| 60 | 2021-02-04 | pain in extremity |
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache w...
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Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
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| 60 | 2021-02-05 | flushing |
Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 ...
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Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.
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| 60 | 2021-02-06 | tremor |
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ...
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High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
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| 60 | 2021-02-07 | weakness | Fever 100.2F; chills, nauseous, weakness |
| 60 | 2021-02-07 | electric shock sensation, tingling |
Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrica...
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Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.
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| 60 | 2021-02-07 | pain in extremity |
high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; ...
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high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
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| 60 | 2021-02-08 | tremor |
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g...
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The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
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| 60 | 2021-02-08 | tenderness |
her face got swollen; lymph node right there it was extremely swollen and very tender and very painf...
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her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
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| 60 | 2021-02-10 | cold extremities, tingling |
02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mout...
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02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand. 6 hours after COVID vaccine had tingling in both hands. 02/06/21 4 AM felt chilled. 8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued. Then developed tingling in left foot & increased tingling in left hand. 02/08/21 Increased tingling in both hands, worse in left 3rd digit. 6 PM had increased tingling in left hand & tingling up into left elbow. 9 PM had increased tingling in right hand. 02/09/21 Tingling in both hands continued all day. Fingers feel cold off &on. 02/10/21 Tingling in both hands continued all day. Fingers feel cold off & on. Tingling in feet, left leg up to knee in evening. 02/11/21 Tingling in both hands continues, fingers feel cold in both hands. Tingling in feet.
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| 60 | 2021-02-14 | tingling |
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE...
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2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
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| 60 | 2021-02-14 | muscle spasms | Intermittent cramping and diahrrea from midnight Sunday through Monday 2/15 (so far) |
| 60 | 2021-02-14 | discomfort |
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea...
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Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
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| 60 | 2021-02-14 | weakness, numbness |
shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakn...
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shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.
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| 60 | 2021-02-15 | feeling cold, pain in extremity, cold extremities |
8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; sev...
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8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.
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| 60 | 2021-02-15 | burning sensation |
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , head...
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Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
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| 60 | 2021-02-16 | speech disorder |
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for...
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Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
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| 60 | 2021-02-16 | difficulty speaking |
Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccinati...
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Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.
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| 60 | 2021-02-16 | flushing |
facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12...
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facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12 hours
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| 60 | 2021-02-17 | pain in extremity, tingling, nerve pain, burning sensation |
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received sec...
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This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 60 | 2021-02-17 | tremor, feeling hot, pain in extremity |
This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to re...
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This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 60 | 2021-02-17 | cold sweat |
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded...
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lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-02-21 | difficulty speaking |
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations...
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During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
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| 60 | 2021-02-21 | weakness, pain in extremity, feeling cold |
Woke up during the night with chills that had my body shivering and a headache. Did not get up unt...
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Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.
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| 60 | 2021-02-23 | flushing, numbness |
Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty brea...
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Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.
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| 60 | 2021-02-23 | migraine |
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos...
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I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
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| 60 | 2021-02-23 | hypersensitivity of all senses, numbness, tingling |
Other than mild soreness at the injection site she experienced no adverse reactions during the first...
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Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation
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| 60 | 2021-02-24 | tingling |
1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order ...
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1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.
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| 60 | 2021-02-24 | sensory loss, pain in extremity, numbness, tingling |
As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left ar...
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As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential
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| 60 | 2021-02-24 | flushing |
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details:...
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
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| 60 | 2021-02-25 | flushing |
About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed...
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About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.
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| 60 | 2021-02-25 | tingling |
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some...
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Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
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| 60 | 2021-02-25 | difficulty speaking |
Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2...
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Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse
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| 60 | 2021-02-25 | burning sensation, tingling, muscle twitching |
Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke...
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Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke up with her heart racing in the am. Pt stated to experience tingling and burning in her feet that later traveled to her hands. Pt has a history of PVCs but noted an increase in the PVC frequency. Chest pain that was intermittent but lasted for 4-5 days. Continues to experience twitches and tingling feet to this day.
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| 60 | 2021-02-26 | feeling hot, tingling, pain in extremity |
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig...
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IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
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| 60 | 2021-02-27 | hot flush |
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Fri...
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Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
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| 60 | 2021-02-27 | numbness, feeling cold, pain in extremity |
My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m ...
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My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder. No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.
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| 60 | 2021-02-27 | pain in extremity |
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches...
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That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
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| 60 | 2021-02-28 | numbness | Numbness sensation in lips to cheeks nose & forehead |
| 60 | 2021-02-28 | pain in extremity |
Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level ...
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Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.
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| 60 | 2021-02-28 | pain in extremity, tenderness |
Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm...
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Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.
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| 60 | 2021-02-28 | pain in extremity |
When I received the vaccine, the technician administering the vaccine had a difficult time pushing i...
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When I received the vaccine, the technician administering the vaccine had a difficult time pushing in the syringe. He moved it around a little bit and pushed hard again. After he pulled the syringe out, he kept tapping it, I guess to make sure all of it went into my arm. When he was administering it, I had a burning sensation as it went in. No one I know had this occur during their vaccine. Due to working environment, I need to know that I received the vaccine, and that something did not go wrong and it failed. Can you let me know if I still received the vaccine after experiencing this during the administration of the vaccine? I am very nervous that it failed and I am not protected. I had a slightly sore arm the evening of the vaccine, but it was gone the next day.
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| 60 | 2021-02-28 | weakness | flu like symptoms, head ache, weakness, body aches |
| 60 | 2021-03-01 | feeling cold |
I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I ...
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I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,
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| 60 | 2021-03-01 | facial paralysis |
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had pa...
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Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
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| 60 | 2021-03-01 | migraine, seizure |
Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ...
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Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads
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| 60 | 2021-03-02 | flushing |
5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore t...
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5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.
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| 60 | 2021-03-02 | tremor |
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet...
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Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
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| 60 | 2021-03-03 | migraine |
At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 1...
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At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.
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| 60 | 2021-03-03 | pain in extremity |
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE...
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SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
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| 60 | 2021-03-04 | flushing, feeling hot |
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev...
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COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
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| 60 | 2021-03-04 | feeling cold |
I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was ...
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I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.
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| 60 | 2021-03-04 | weakness |
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature ...
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Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
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| 60 | 2021-03-04 | pain in extremity |
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m...
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Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
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| 60 | 2021-03-04 | difficulty speaking | Scatchy throat, affected voice, swollen tongue |
| 60 | 2021-03-04 | numbness | Within 15 minutes right facial numbness and eyelid swelling, mild lid droop, lasted 4 hours |
| 60 | 2021-03-05 | tingling |
Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheade...
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Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.
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| 60 | 2021-03-06 | tingling, pain in extremity |
Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til ...
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Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen
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| 60 | 2021-03-07 | pain in extremity, weakness |
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme...
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Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
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| 60 | 2021-03-07 | flushing |
Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she...
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Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma
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| 60 | 2021-03-07 | pain in extremity |
left arm became red and tender 2 days after the shot- and has continued for a total of 3 days withou...
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left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change
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| 60 | 2021-03-07 | numbness | numbness right arm, dizziness, lips numb. Evaluated by EMS-Cleared |
| 60 | 2021-03-08 | hypersensitivity of all senses, weakness |
Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hur...
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Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.
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| 60 | 2021-03-08 | weakness | Low-grade fever, chills, body weakness, aches, brain fog, fatigue |
| 60 | 2021-03-08 | tingling |
This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier t...
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This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
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| 60 | 2021-03-08 | flushing | flushed, redness around mouth. Evaluated by EMS-Cleared |
| 60 | 2021-03-09 | weakness |
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3...
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On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
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| 60 | 2021-03-09 | weakness |
Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction....
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Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.
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| 60 | 2021-03-09 | difficulty speaking |
acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse ...
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acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER
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| 60 | 2021-03-09 | burning sensation |
burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologi...
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burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10
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| 60 | 2021-03-09 | weakness |
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after in...
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mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.
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| 60 | 2021-03-09 | feeling hot |
within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my b...
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within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
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| 60 | 2021-03-10 | pain in extremity |
Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for ...
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Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for 48hrs following 2nd shot. Pain in arm for about 4 days following both shots
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| 60 | 2021-03-10 | breast pain |
My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or...
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My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.
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| 60 | 2021-03-10 | tingling, numbness |
Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numb...
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Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.
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| 60 | 2021-03-10 | pain in extremity | severe arm pain, lasting two days. |
| 60 | 2021-03-11 | tremor |
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro...
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Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
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| 60 | 2021-03-11 | tremor |
Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 150...
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Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
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| 60 | 2021-03-13 | breast pain, feeling of body temperature change |
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:...
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2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
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| 60 | 2021-03-13 | burning sensation |
I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will ...
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I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.
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| 60 | 2021-03-13 | tremor |
Patient presents with feeling lightheaded after she got the second dose of her Pfizer vaccine about ...
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Patient presents with feeling lightheaded after she got the second dose of her Pfizer vaccine about half an hour ago. She is brought over here by staff at the vaccine clinic. She continues to have some shakiness. She denies any pain or shortness of breath. Symptoms are worse when she is sitting up. She has had syncopal episode in the past. Denies any chest pain.
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| 60 | 2021-03-13 | pain in extremity | Severe diahrrea, lightheadedness, headache, legs ached- started around 4:00 pm No treatment |
| 60 | 2021-03-14 | discomfort |
Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the ...
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Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday through Friday. Could not get comfortable.
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| 60 | 2021-03-14 | flushing |
PATIENT STATED IMMEDIATELY AFTER RECEIVING IMMUNIZATION THAT SHE HAD A "FLUSHING" FEEL, BUT THAT IT ...
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PATIENT STATED IMMEDIATELY AFTER RECEIVING IMMUNIZATION THAT SHE HAD A "FLUSHING" FEEL, BUT THAT IT IS NORMAL FOR HER TO GET THAT WAY WITH CERTAIN THINGS. PATIENT WAS MONITORED BUT RECEIVED NO MEDICATION.
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| 60 | 2021-03-14 | breast pain | Pain in my left armpit and left breast area |
| 60 | 2021-03-14 | throat numbness | Throat feels numb and SOB P-64 R-20 116/76 Transported No EPI given at time |
| 60 | 2021-03-15 | tremor |
15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fe...
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15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.
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| 60 | 2021-03-15 | feeling hot |
3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat ...
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3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.
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| 60 | 2021-03-15 | feeling hot |
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hou...
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About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
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| 60 | 2021-03-15 | tremor |
Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also...
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Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.
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| 60 | 2021-03-15 | breast pain |
Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She cam...
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Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.
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| 60 | 2021-03-15 | flushing, burning sensation |
This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of t...
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This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.
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| 60 | 2021-03-15 | feeling hot, feeling cold |
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t...
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Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
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| 60 | 2021-03-15 | tingling |
my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow wate...
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my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.
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| 60 | 2021-03-16 | numbness | Around the outside of my mouth and nose became numb. Lasted about 4 Hours. |
| 60 | 2021-03-16 | numbness, tingling |
As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vacc...
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As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.
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| 60 | 2021-03-16 | tingling | Felt anxious, with chills/tingling in feet. BPs 174/77 (pulse 71), O2 sat 98%. Final BP 134/75. |
| 60 | 2021-03-16 | numbness | Hematoma to left arm. Metallic taste. Numbness in face and tongue. |
| 60 | 2021-03-16 | unresponsive to stimuli, hot flush | Hot Flash with Sweats, Followed by fainting, Non-responsive, Elevated blood pressure |
| 60 | 2021-03-16 | pain in extremity |
Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick ...
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Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
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| 60 | 2021-03-16 | weakness |
Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earli...
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Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.
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| 60 | 2021-03-16 | hot flush |
Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feelin...
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Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feeling better, paramedics released her to home.
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| 60 | 2021-03-16 | feeling cold, tingling |
The event began with me feeling extremely cold and unable to warm up. It later progressed to needle...
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The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.
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| 60 | 2021-03-16 | pain in extremity | left arm soreness, headache, upset stomach, tired |
| 60 | 2021-03-17 | pain in extremity |
/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, tak...
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/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, taking tylenol & ibuprofen PRN, No other complaints at this time. Advised to continue with Tylenol/ibuprofen and contact PCP if symptoms worsen.
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| 60 | 2021-03-17 | bell's palsy | Bell's palsy left face |
| 60 | 2021-03-17 | pain in extremity |
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ...
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Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-17 | pain in extremity |
Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and nec...
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Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.
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| 60 | 2021-03-17 | numbness |
Left side of left arm became numb, down side of arm and three fingers. Left side of left leg also fe...
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Left side of left arm became numb, down side of arm and three fingers. Left side of left leg also felt numb but half as much as the arm. No treatment. It went away by 10 am the next morning.
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| 60 | 2021-03-17 | weakness | Temperature 103 degrees and weakness |
| 60 | 2021-03-17 | unresponsive to stimuli |
This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was s...
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This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am
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| 60 | 2021-03-17 | numbness, pain in extremity | numbness, pain and weakness to lower extremities. |
| 60 | 2021-03-18 | pain in extremity |
Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired ...
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Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.
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| 60 | 2021-03-18 | pain in extremity |
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fat...
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Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
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| 60 | 2021-03-18 | pain in extremity |
I had no side effects except a sore arm with both doses of the vaccine. Only this week I started to ...
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I had no side effects except a sore arm with both doses of the vaccine. Only this week I started to experience ringing in my ears (tinnitus) and I have never had that before. The only reason I thought it was related to the vaccine was that my husband experienced the same symptoms recently as well and he received both doses of Moderna vaccine in January. I find it very strange that we are experiencing these symptoms now after more than a month of getting a second dose of the vaccine.
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| 60 | 2021-03-19 | feeling hot |
5 minutes after the shot, a feeling of warmth went through my upper body to my head & my tongue was ...
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5 minutes after the shot, a feeling of warmth went through my upper body to my head & my tongue was tingling. It lasted about 30 seconds. It happened again about 1/2 hour later (11:12 am) but not as strong or as long.
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| 60 | 2021-03-19 | weakness | Body aches, fever (100.8 - my regular temp is 97.5, very low energy |
| 60 | 2021-03-19 | pain in extremity | Body aches, headache, fatugue, sore throat, sore arm |
| 60 | 2021-03-19 | pain in extremity |
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ...
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Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
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| 60 | 2021-03-19 | nerve pain | Fibromyalgia flare and nerve pain, low grade fever, extreme fatigue second day after vaccination |
| 60 | 2021-03-19 | nerve pain, numbness, tremor, numbness and pain in extremities, pain in extremity, tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both...
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Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both feet and both lower legs mainly at night. Difficulty sleeping. This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs and into my arms and hands but not as intense as in my feet and lower legs Tingling, shakiness felt in muscles is continuous now, not just at night. I was scheduled to have 2nd dose today but decided not to go through with getting it. Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy. I decided I did not want the 2nd dose.
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| 60 | 2021-03-20 | tremor |
COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 p...
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COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
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| 60 | 2021-03-20 | pain in extremity |
I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. A...
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I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.
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| 60 | 2021-03-21 | weakness, tremor |
03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD...
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03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.
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| 60 | 2021-03-21 | hot flush, pain in extremity, feeling cold |
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl...
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8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
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| 60 | 2021-03-21 | pain in extremity |
By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me ...
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By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.
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| 60 | 2021-03-21 | flushing |
Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started af...
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Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.
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| 60 | 2021-03-21 | tingling |
Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the muc...
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Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.
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| 60 | 2021-03-21 | tingling | Tingling around mouth/face. Evaluated by EMS-Cleared |
| 60 | 2021-03-22 | feeling hot, tingling, weakness |
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing...
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At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
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| 60 | 2021-03-22 | pain in extremity |
Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning th...
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Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.
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| 60 | 2021-03-22 | pain in extremity |
I could actually feel the vaccine entering my blood stream above and below injection area. I had sh...
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I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.
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| 60 | 2021-03-22 | difficulty speaking | Pt developed dyspnea, significant voice changes and pruritus. Symptoms almost completely resolved.0 |
| 60 | 2021-03-22 | weakness |
Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr o...
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Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr on 3/16/2021 Steroid cream, tylenol, and Xrays done. Informed that they might need to do an MRI. At this time she does not feel like it is getting any better. Sometimes hurts more than other times depending on activity, feels heavy and week. Can feel it poping and grinding with movement.
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| 60 | 2021-03-22 | pain in extremity |
Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a pla...
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Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache
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| 60 | 2021-03-22 | numbness | the left side of the face numb from forehead down to chin |
| 60 | 2021-03-23 | tingling |
After I left the facility, driving home I notice that my back was starting to hurt, so I turned on t...
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After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.
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| 60 | 2021-03-23 | weakness |
As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vacc...
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As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.
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| 60 | 2021-03-23 | pain in extremity |
I was submitting my events daily on website and two days it tells me my session has expired and won'...
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I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
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| 60 | 2021-03-23 | tingling |
Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient ref...
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Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient refused a second set of vital signs. Patient felt fine after speaking with the medical doctor and went home.
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| 60 | 2021-03-23 | numbness |
Patient complained of numbness to her left hand. She reports "like hand is asleep but very faint." R...
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Patient complained of numbness to her left hand. She reports "like hand is asleep but very faint." Reported the sensation began around 15 minutes after the injection. Patient stated that she is "not afraid and the sensation is still present but is barely noticeable." Patient did not have difficulty breathing and declined vital signs. Patient was advised by staff to login to report further symptoms and to go to the ER for worsening reactions.
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| 60 | 2021-03-23 | weakness |
Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complainin...
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Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**
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| 60 | 2021-03-23 | weakness |
Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next da...
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Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.
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| 60 | 2021-03-23 | muscle spasms |
received the Pfizer COVID vaccine dose 1 (lot ER8732, expiration 7/2021) at 0915. Patient reported t...
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received the Pfizer COVID vaccine dose 1 (lot ER8732, expiration 7/2021) at 0915. Patient reported to at 0920 that she was experiencing a bitter and metallic taste in her mouth and cramping in her wrist. Vital signs: O2 98%, pulse 73, blood pressure 140/82, respirations 16. Patient reported the taste had disappeared but the cramping radiated up her arm to the axilla. Medical conditions include: diabetes mellitus type II, pacemaker, status post stroke in 2017, hysterectomy in 2012, breast cancer in 1998 in remission, hypertension. Patient reported her normal blood pressure is 140s/80s. Medications: synthroid, levothyroxin, novolin, Humulin R, niacin and fish oil. Allergies include corticosteroids, codeine, sulfa, citric acid. Patient denied edema, tingling, pain, or dizziness. Patient reported she had not eaten breakfast and only drank a few sips of water with her morning medications. EMT advised patient to move arm and wrist continuously to promote circulation. At 930, offered Benadryl that patient declined, also advised patient to notify provider and signs when to contact 911. Patient drank approximately 8 oz of water, ate a small snack of pistachios, and reported improvement in cramping and taste resolved. At 940, vital signs: O2 97%, pulse 65, respirations 16, blood pressure 142/86. Patient reported symptoms had resolved. At 0952 vital signs: O2 99%, pulse 64, respirations 16, blood pressure 140/82. Patient left walking with steady gait.
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| 60 | 2021-03-24 | feeling hot |
After coming into the observation post vaccination, the patient told the nurse that she was itchy. T...
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After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.
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| 60 | 2021-03-24 | pain in extremity | Fever, 100 F. Chills Nausea Sore Arm |
| 60 | 2021-03-24 | numbness and pain in extremities |
neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable cons...
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neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-03-24 | pain in extremity |
sore arm, started to hurt in the afternoon treating it at home with cold pack, trying to avoid OTC m...
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sore arm, started to hurt in the afternoon treating it at home with cold pack, trying to avoid OTC medications
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| 60 | 2021-03-24 | weakness |
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m...
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this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
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| 60 | 2021-03-25 | hot flush |
seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I ...
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seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.
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| 60 | 2021-03-25 | weakness |
things went black; my blood pressure was alarmed was over 200 checked other arm same called there te...
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things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-03-26 | pain in extremity |
1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12mi...
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1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.
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| 60 | 2021-03-26 | migraine | Extreme headache (migraine) lasting 48 hours Extreme fatigue lasting 48 hours |
| 60 | 2021-03-26 | feeling hot, nerve pain, pain in extremity |
On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all d...
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On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all down the arm from 3/19 and still continuing today 3/27. Took Tylenol and used ice on shoulder and arm. Had a massage and stretching done on 3/23 didn?t help much. Contacted my doctors office on 3/23 and have an appointment for 3/31. The symptoms I?m feeling is that of SIRVA. Went to urgent care on 3/26 and was told that ?that is a symptom of the vaccine, give it another day?. Told them it was over a week and the pain I?m feeling is nerve pain. I was told there was nothing they can do for me there. Still feeling the pain today. Still icing and using Voltaren gel to help with inflammation.
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| 60 | 2021-03-26 | pain in extremity, numbness |
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip complete...
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Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
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| 60 | 2021-03-26 | muscle spasms |
Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody ...
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Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody diarrhea again.
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| 60 | 2021-03-26 | burning sensation |
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., s...
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Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
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| 60 | 2021-03-26 | pain in extremity | left arm pain radiating down to wrist from shoulder shoulder pain back shoulder pain |
| 60 | 2021-03-26 | pain in extremity |
soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire n...
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soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire next day along with fatigue. Today, March 27th, I have woken up feeling better, no fever.
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| 60 | 2021-03-27 | tingling |
Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described...
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Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth. A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally. Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.
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| 60 | 2021-03-27 | difficulty speaking, tremor |
Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; t...
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Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.
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| 60 | 2021-03-27 | weakness, unresponsive to stimuli, tremor |
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness...
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Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
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| 60 | 2021-03-28 | weakness | BP 153/89, HR 84,O2 100%, 12 lead normal. Anxiety, weakness, palpitations. Exit time 11:22 am. |
| 60 | 2021-03-28 | weakness | Extreme headache for 3 days weak and tired very sore arm at injection site |
| 60 | 2021-03-28 | muscle spasms | HA, shivers at night , muscle cramps , mild fever |
| 60 | 2021-03-28 | weakness |
Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy W...
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Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness
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| 60 | 2021-03-28 | breast pain |
The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it cam...
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The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it came back two days later positive for covid. 24 hours after 3nd vaccine. Also have pain in left breast Under arm where shot was given
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| 60 | 2021-03-29 | flushing |
Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from ...
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Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.
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| 60 | 2021-03-30 | pain in extremity |
her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell lik...
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her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.
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| 60 | 2021-03-31 | numbness |
3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of fac...
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3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.
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| 60 | 2021-04-01 | bell's palsy |
she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a cont...
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she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
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| 60 | 2021-04-02 | numbness |
Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a...
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Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.
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| 60 | 2021-04-03 | muscle spasms |
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post...
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12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
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| 60 | 2021-04-05 | tremor, pain in extremity, burning sensation |
Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted...
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Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted 4 days follow by burning and painfully legs especially, in calf area made walking painful. As of this report legs still painful.
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| 60 | 2021-04-06 | pain in extremity |
Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneou...
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Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.
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| 60 | 2021-04-06 | difficulty speaking |
My throat was itchy in between that half hour my voice started to change; my throat felt worse; I ha...
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My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-04-06 | pain in extremity |
On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then th...
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On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.
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| 60 | 2021-04-07 | weakness |
shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital ...
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shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2
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| 60 | 2021-04-09 | hot flush |
Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along...
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Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.
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| 60 | 2021-04-09 | pain in extremity, burning sensation, tremor |
vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urin...
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vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
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| 60 | 2021-04-12 | slurring, numbness |
Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional...
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Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.
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| 60 | 2021-04-17 | bell's palsy |
Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). ...
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Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient (patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number En6208), via an unknown route on 15Mar2021 at 12:00 pm (at the age of 60-years-old) at single dose on the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Relevant concomitant medications patient received within 2 weeks of vaccination included pantoprazole 40mg. On 15Mar2021 at 12:00, the patient had Bells Palsy right side of face. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the event. Outcome of the event Bells Palsy right side of face was recovered in 2021. Follow up attempts are needed. Information on the lot/batch number has been requested.
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| 60 | 2021-04-18 | numbness, tingling |
Patient had her first covid vaccine injection at 0722 this am. She was escorted to the observation...
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Patient had her first covid vaccine injection at 0722 this am. She was escorted to the observation room where she told her nurse that she was experiencing tingling and numbness on the right side of her face from the nose down to the middle of her lip including half her tongue at 0730. Patient verbalized she had a TIA 10 years ago and this is how she felt when she had that event. She states she has a history of hypertension and a recently diagnosed aneurysm in her spleen. vital signs were obtained blood pressure 168/121, Heart rate 68, O2 sat on room air 99 % She denied any pain. Asked patient to stick her tongue out and it was midline before vitals slightly deviated after vitals were finished. Patient then states she feels like her face is swelling on the right side. ER was called. Patient taken to ER by wheelchair for follow up evaluation. Event documented on patient consent and event reported. Patient later admitted to hospital.
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| 60 | 2021-04-18 | burning sensation, pain in extremity |
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti...
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appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
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| 60 | 2021-04-20 | cold sweat |
I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all co...
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I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
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| 60 | 2021-04-20 | numbness, tingling |
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ...
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her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 60 | 2021-04-21 | breast pain |
1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of...
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1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,
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| 60 | 2021-04-24 | bell's palsy, feeling cold |
Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a cont...
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Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in right arm on 01Apr2021 15:15 (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure. The patient had known allergies with Allegra. Concomitant medications included pravastatin; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and bupropion. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), administered in the left arm on 14Mar2021 at 04:00 PM for COVID-19 immunisation. On 02Apr2021 at 13:00, the patient got freezing cold. The patient was cold for several hours. On 03Apr2021, the patient woke up and right side of mouth felt numb. The patient went to urgent care and was diagnosed with Bell's Palsy on 03Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy, freezing cold, and right side of mouth felt numb. The patient had not yet recovered from the events.
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| 60 | 2021-04-24 | tremor |
possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like...
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possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.
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| 60 | 2021-04-26 | flushing |
Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccinat...
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Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.
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| 60 | 2021-04-26 | pain in extremity, feeling hot |
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem...
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This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
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| 60 | 2021-04-26 | slurring, numbness |
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ...
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her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
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| 60 | 2021-04-27 | weakness |
She had a slow infection in her chest; She was breathing fine, but she got out of breath every now a...
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She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 60 | 2021-04-27 | muscle spasms |
thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is e...
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thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 60 | 2021-04-30 | discomfort, difficulty speaking, flushing |
Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little t...
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Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.
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| 60 | 2021-04-30 | weakness |
Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Diz...
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Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-04-30 | bell's palsy |
Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry le...
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Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-04-30 | numbness, difficulty speaking |
Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency ...
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Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-04-30 | weakness, pain in extremity |
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,...
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anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
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| 60 | 2021-05-04 | pain in extremity |
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha...
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blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
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| 60 | 2021-05-06 | feeling hot, cold sweat, hypersensitivity of all senses |
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye...
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Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
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| 60 | 2021-05-13 | difficulty speaking |
My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice sta...
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My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.
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| 61 | 2020-12-31 | muscle spasms | Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping |
| 61 | 2021-01-03 | burning sensation, cold extremities, speech disorder |
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ...
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About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
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| 61 | 2021-01-03 | weakness | Extreme fatigue, weakness, lightheaded, malaise |
| 61 | 2021-01-03 | numbness, tingling |
Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-1...
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Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination. Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.
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| 61 | 2021-01-04 | feeling of body temperature change |
Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills...
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Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
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| 61 | 2021-01-04 | muscle twitching, feeling jittery |
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat...
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Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
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| 61 | 2021-01-04 | discomfort, hot flush |
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was fr...
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aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
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| 61 | 2021-01-04 | feeling hot |
development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all ove...
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development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness
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| 61 | 2021-01-05 | numbness |
I went to the emergency room which after the Pfizer injection I had numbness sensation to my face a...
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I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.
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| 61 | 2021-01-05 | pain in extremity | Sore arm starting about 2 days after vaccination lasting for 48 hours. |
| 61 | 2021-01-06 | pain in extremity |
Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; Th...
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Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
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| 61 | 2021-01-06 | weakness | Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea |
| 61 | 2021-01-06 | throat numbness |
Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back ...
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Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.
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| 61 | 2021-01-06 | burning sensation, weakness, cold extremities, speech disorder, tremor |
Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside t...
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Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-06 | numbness, cold extremities |
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the s...
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left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe
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| 61 | 2021-01-07 | discomfort |
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after...
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1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
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| 61 | 2021-01-07 | flushing | Chills. Nausea. Headache. Body aches. Flushed face |
| 61 | 2021-01-07 | weakness |
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had ...
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Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
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| 61 | 2021-01-07 | tremor |
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one ho...
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Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
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| 61 | 2021-01-07 | pain in extremity | fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough |
| 61 | 2021-01-07 | pain in extremity, numbness |
pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a ...
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pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported. The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event. Information on the lot/Batch number has been requested.
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| 61 | 2021-01-08 | feeling hot |
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d...
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About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
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| 61 | 2021-01-08 | burning sensation, flushing |
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da...
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First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
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| 61 | 2021-01-08 | pain in extremity | Low grade fever, fatigue, body aches, arm pain |
| 61 | 2021-01-08 | breast pain |
muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blis...
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muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast
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| 61 | 2021-01-09 | numbness |
Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambul...
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Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.
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| 61 | 2021-01-09 | pain in extremity | chills, fever, arm pain |
| 61 | 2021-01-10 | pain in extremity |
24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 h...
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24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair
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| 61 | 2021-01-10 | numbness |
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a...
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I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
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| 61 | 2021-01-10 | pain in extremity | Low grade fever body aches chills headache arm soreness |
| 61 | 2021-01-10 | pain in extremity |
Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to...
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Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.
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| 61 | 2021-01-10 | pain in extremity | SORE ARM,HEADACHE LOWER BACK PAIN FATIGUE |
| 61 | 2021-01-11 | feeling jittery |
After patient had received vaccine, a vaccinator was called by a member of the healthcare facility t...
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After patient had received vaccine, a vaccinator was called by a member of the healthcare facility to assess the patient. The patient was jittery and exhibited signs of confusion approximately 20 minutes (3PM) after her vaccination. The vaccinator asked if she was diabetic and the patient replied "yes" and takes metformin. Further questioning revealed that the patient had not eaten since 9AM - it was then around 3PM. The ambulance was called and the patient went to the hospital. Probe revealed that she had not taken her diabetic medication and that the patient had not eaten or drink. Patient was encouraged by vaccinator to eat on time and take her medicine as prescribed.
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| 61 | 2021-01-11 | pain in extremity |
Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand o...
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Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine
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| 61 | 2021-01-11 | weakness | Fever/chills 104.8, N/V, severe fatigue/weakness, severe headache, body aches |
| 61 | 2021-01-11 | feeling hot |
Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hour...
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Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.
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| 61 | 2021-01-11 | pain in extremity | myalgias, chills, left arm soreness, vertigo |
| 61 | 2021-01-12 | weakness |
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills ...
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Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.
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| 61 | 2021-01-12 | flushing | Flushing of neck and cheeks. |
| 61 | 2021-01-12 | muscle spasms |
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo...
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Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
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| 61 | 2021-01-12 | tingling, numbness |
On my drive back to work after getting the vaccine the left lower part of my face when numb and ting...
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On my drive back to work after getting the vaccine the left lower part of my face when numb and tingly. Then it focused on my left nostril. The overall effect didn't last long but my nostril still doesn't feel right. Somewhat numb but not always. The left side of my face feels strange at times as well. Hard to explain.
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| 61 | 2021-01-12 | tingling, speech disorder, discomfort |
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o...
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Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
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| 61 | 2021-01-12 | pain in extremity, tremor |
Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant bod...
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Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.
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| 61 | 2021-01-13 | hot flush, pain in extremity |
About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I ...
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About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.
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| 61 | 2021-01-13 | hot flush |
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a...
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At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
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| 61 | 2021-01-13 | weakness |
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at mid...
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Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
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| 61 | 2021-01-13 | face paralysis, tremor |
Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determi...
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Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ
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| 61 | 2021-01-14 | weakness |
Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating...
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Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.
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| 61 | 2021-01-14 | pain in extremity |
DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/...
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DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.
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| 61 | 2021-01-14 | tenderness, feeling cold | Feeling cold, headache, chills, tender arm, fever |
| 61 | 2021-01-14 | flushing |
Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling...
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Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling flush and cheeks were slightly red. O2 sats 98%, HR 62 bpm, denies shortness of breath. Notified Dr. who gave a telephone order for Benadryl 25mg PO now. Instructed patient to stay 30 additional for observation post Benadryl administration.
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| 61 | 2021-01-14 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje...
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Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
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| 61 | 2021-01-14 | breast pain, pain in extremity, tenderness |
Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, ...
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Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10
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| 61 | 2021-01-14 | hypersensitivity of all senses |
Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back)...
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Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
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| 61 | 2021-01-14 | pain in extremity |
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then...
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but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 61 | 2021-01-15 | tingling |
immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by ...
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immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.
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| 61 | 2021-01-17 | numbness |
2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout mu...
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2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.
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| 61 | 2021-01-17 | pain in extremity |
Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, ha...
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Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside. Tried taking over counter meds, nothing is helping with pain.
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| 61 | 2021-01-17 | feeling jittery, tremor, tingling, feeling cold |
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left...
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Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
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| 61 | 2021-01-18 | pain in extremity |
DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 TH...
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DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19
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| 61 | 2021-01-18 | pain in extremity |
Severe Left Leg Pain, thing started about three hours after the shot and it so severe screaming an...
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Severe Left Leg Pain, thing started about three hours after the shot and it so severe screaming and needed pain medicine . The next morning left work due to pain . 12/28/2020. Physical Exam and called it sciatica but not what it was It was inflammation of left fascia lata the Tramadol 50mg and Percocet 5 mg and Prednisone 5 days and it was better by 90% after receiving second shot worsened for a day then back 90%
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| 61 | 2021-01-18 | pain in extremity |
Though I had pain and soreness in the arm after both the shots I am left with a residual weakness an...
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Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.
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| 61 | 2021-01-18 | tremor | chills shakes nausea vomiting cough sob sore throat maliase |
| 61 | 2021-01-18 | burning sensation |
she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had...
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she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.
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| 61 | 2021-01-19 | difficulty speaking |
After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to dev...
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After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.
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| 61 | 2021-01-19 | flushing, tingling |
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and ...
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Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
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| 61 | 2021-01-19 | tingling, flushing |
Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccinat...
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Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.
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| 61 | 2021-01-19 | feeling cold, tingling, feeling hot |
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa...
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I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
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| 61 | 2021-01-19 | pain in extremity | Larm pain, low grade temp to 100.2, mild headache |
| 61 | 2021-01-19 | breast pain | Painful lymph node in the arm where she had the vaccination and radiates to her breast |
| 61 | 2021-01-19 | muscle spasms, muscle twitching |
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours...
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Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
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| 61 | 2021-01-19 | tingling | Tingling in left face check..legs very weak .. congestion..very tired for 4 days |
| 61 | 2021-01-20 | feeling hot |
Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6...
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Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.
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| 61 | 2021-01-20 | feeling cold | Day after 2nd vaccine, developed chills, fever of 99.4, and overall body aches |
| 61 | 2021-01-20 | weakness, feeling hot | Felt very weak and very hot. No fever. |
| 61 | 2021-01-20 | pain in extremity | Global myalgia, chills, high fever, significant arm pain. Excedrin used. Symptoms mostly resolved. |
| 61 | 2021-01-20 | discomfort |
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati...
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felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
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| 61 | 2021-01-20 | hypersensitivity of all senses |
sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneo...
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sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 61 | 2021-01-21 | weakness, tremor |
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe...
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I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
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| 61 | 2021-01-21 | migraine |
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine....
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STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
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| 61 | 2021-01-21 | pain in extremity | Sore arm |
| 61 | 2021-01-23 | tingling |
Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs...
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Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.
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| 61 | 2021-01-24 | tingling |
Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left...
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Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.
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| 61 | 2021-01-24 | facial paralysis |
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor...
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Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
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| 61 | 2021-01-25 | numbness, tremor |
Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. ...
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Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.
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| 61 | 2021-01-25 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 1...
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Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.
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| 61 | 2021-01-26 | flushing |
After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was ...
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After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.
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| 61 | 2021-01-26 | hot flush, weakness, cold sweat, pain in extremity |
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl...
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Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
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| 61 | 2021-01-26 | feeling cold |
Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1...
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Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1:30 p.m. I went straight home from work. I took shoes off and got in bed. I was very cold and felt that the coldness was from inside out especially in my hands. I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands. I got up at 5 p.m and felt better. Tuesday morning, January 26 at 3 a.m. when I got up to shower, I noticed a soreness and large swelling under left armpit, ? lymphadenopathy. All others symptoms had passed. Continues to be the same on today, January 27. Seeing MD on Thursday, January 28.
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| 61 | 2021-01-26 | feeling cold |
felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; Th...
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felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.
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| 61 | 2021-01-26 | tremor | headache, shakiness, chills, lightheadedness |
| 61 | 2021-01-26 | one side paralysis, facial paralysis | hemiparesis left, facial droop, weakness on left upper and lower extremity |
| 61 | 2021-01-26 | pain in extremity |
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes...
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unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-27 | difficulty speaking |
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; t...
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10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on
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| 61 | 2021-01-27 | feeling cold |
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headac...
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A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
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| 61 | 2021-01-27 | unresponsive to stimuli |
Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been r...
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Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.
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| 61 | 2021-01-27 | pain in extremity |
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contact...
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Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
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| 61 | 2021-01-27 | weakness |
Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for...
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Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
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| 61 | 2021-01-27 | numbness |
about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained sli...
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about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained slightly numb; This is a spontaneous report from a contactable nurse. A 61-year-old female nurse reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1686), intramuscular at single dose into the left arm on 08Jan2021 at 03:30 PM for COVID-19 immunization. First dose of BNT162B2 was received on 18Dec2020. Medical history included rheumatoid arthritis, coronary artery disease and hypertension. Past drug history included NSAIDS which caused bleeding. The patient's concomitant medications were not reported. The patient reported that about 30-45 minutes after vaccination she started feeling numbness on left side of face and left lower lip remained slightly numb. The events were reported as non-serious. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
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| 61 | 2021-01-27 | feeling hot |
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer ...
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headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
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| 61 | 2021-01-27 | tremor | immediately following the vaccine she experienced a horrible headache, dizziness, and shakiness |
| 61 | 2021-01-27 | feeling hot |
tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe naus...
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tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.
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| 61 | 2021-01-28 | weakness |
Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol ...
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Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.
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| 61 | 2021-01-28 | pain in extremity |
day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around...
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day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.
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| 61 | 2021-01-29 | bell's palsy |
Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. n...
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Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. noticeable onset this morning 1/30 with right eye right and upper lip involvement.
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| 61 | 2021-01-29 | numbness |
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ...
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alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
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| 61 | 2021-01-29 | flushing |
in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt...
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in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.
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| 61 | 2021-01-30 | pain in extremity, weakness, discomfort, feeling cold |
12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, fe...
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12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)
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| 61 | 2021-01-30 | tremor |
Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and b...
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Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting
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| 61 | 2021-01-31 | pain in extremity |
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness...
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Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
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| 61 | 2021-01-31 | weakness |
Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to...
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Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.
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| 61 | 2021-01-31 | numbness, tingling | right arm numbness and tingling |
| 61 | 2021-02-01 | flushing |
I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on f...
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I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl. Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe Delaying second vaccine by a week or two until this resolves per DR
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| 61 | 2021-02-01 | pain in extremity |
Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hur...
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Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
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| 61 | 2021-02-01 | pain in extremity |
sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache;...
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sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.
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| 61 | 2021-02-01 | weakness |
thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report fro...
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thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
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| 61 | 2021-02-02 | tingling |
C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS S...
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C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER
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| 61 | 2021-02-02 | migraine | Migraine headache chills and joint pain |
| 61 | 2021-02-02 | numbness | Sudden total hearing loss, left ear; numbness in face and outer ear. |
| 61 | 2021-02-03 | feeling cold |
12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation...
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12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.
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| 61 | 2021-02-03 | tingling, numbness |
Redness numbness and tingling in both hands Increases when hands are pointed down improves when lif...
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Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future
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| 61 | 2021-02-04 | pain in extremity | BODY ACHES, CHILLS, JOINT PAIN, ARM SORENESS |
| 61 | 2021-02-04 | pain in extremity |
Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache a...
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Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.
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| 61 | 2021-02-04 | weakness, facial paralysis |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
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| 61 | 2021-02-04 | feeling hot |
sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all da...
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sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.
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| 61 | 2021-02-06 | feeling jittery, pain in extremity, tension headache |
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba...
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I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
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| 61 | 2021-02-06 | tingling, flushing |
Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with...
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Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.
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| 61 | 2021-02-07 | pain in extremity |
She had significant fatigue the day after the injection along with a sore arm and intermittent heada...
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She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.
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| 61 | 2021-02-07 | pain in extremity | Sore arm and neck on injection side |
| 61 | 2021-02-07 | pain in extremity | Sore arm. Nausea. Fatigue |
| 61 | 2021-02-07 | tingling |
Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symp...
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Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.
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| 61 | 2021-02-07 | pain in extremity |
arm pain; This is a spontaneous report from a contactable Health Professional. A 61-year-old female ...
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arm pain; This is a spontaneous report from a contactable Health Professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Jan2021 (at the age of 61-years) as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain from vaccination on an unspecified date. The clinical outcome of the event was unknown.
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| 61 | 2021-02-07 | flushing |
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no it...
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facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
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| 61 | 2021-02-08 | tingling |
Feeling like I'm being pricked from the waist down. It's in varying spots and doesn't last long in a...
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Feeling like I'm being pricked from the waist down. It's in varying spots and doesn't last long in any one spot. Assuming this is a nerve reaction.
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| 61 | 2021-02-08 | bell's palsy | I got Bell Palsy after 3 weeks (#2) vaccine. |
| 61 | 2021-02-08 | pain in extremity |
Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more tha...
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Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.
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| 61 | 2021-02-08 | flushing, tingling |
Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated w...
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Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.
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| 61 | 2021-02-09 | inability to speak, pain in extremity |
30 minutes after injection: severe headache, general feeling of illness. Following day in the mornin...
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30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing
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| 61 | 2021-02-09 | muscle spasms, weakness |
Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneou...
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Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
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| 61 | 2021-02-10 | weakness | ELEVATED TEMP OF 101, CHILLS ACHES, HEADACHE, WEAKNESS |
| 61 | 2021-02-14 | pain in extremity, numbness | Feeling painful numbness of finger tips of left hand which is migrating different fingers. |
| 61 | 2021-02-14 | muscle spasms | Fever, Chills, Severe Muscle Cramps, Headache, Extreme Fatigue, Dizziness, Inflammation |
| 61 | 2021-02-14 | feeling hot, feeling cold, weakness, tremor |
I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a ...
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I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.
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| 61 | 2021-02-14 | tingling |
On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck u...
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On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck under my chin. On February 5, 2021 I started taking benedryl 25mg to combat the itching. By February 8, I had a fine rash, small raised all around my neck and very itchy and again I took benadryl without improvement. Benadryl would have a short term effect and just made me sleepy. This continued for 3 more days until February 15 when I was able to see my doctor who has now listed me as having a reaction and allergic to the Covid 19 Vaccine. I am prescribed topical steroid cream and hopefully it will improve.
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| 61 | 2021-02-14 | pain in extremity |
Patient felt moderate hand pain following injection. was evaluated by clinician on site and instruct...
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Patient felt moderate hand pain following injection. was evaluated by clinician on site and instructed to take routine pain medication once patient was home.
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| 61 | 2021-02-14 | pain in extremity |
Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and con...
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Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.
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| 61 | 2021-02-14 | migraine, numbness |
Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and ...
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Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.
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| 61 | 2021-02-15 | tenderness, pain in extremity |
Left thumb and all the way to the wrist sore, inflammation, very painful, sore, tender, stiff. on a ...
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Left thumb and all the way to the wrist sore, inflammation, very painful, sore, tender, stiff. on a scale of 1 to 10 on pain, it is an 8. Keep thinking it will get better each day but it is not getting better.
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| 61 | 2021-02-16 | paralysis |
61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief compl...
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61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.
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| 61 | 2021-02-16 | pain in extremity |
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101...
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Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
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| 61 | 2021-02-16 | pain in extremity |
Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, sev...
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Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.
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| 61 | 2021-02-16 | numbness |
The right side of my face has gone numb as if I had a dentist's injection. Started the same evening ...
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The right side of my face has gone numb as if I had a dentist's injection. Started the same evening as the vaccination. Includes even the ear.
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| 61 | 2021-02-16 | tingling, migraine |
almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia a...
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almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 61 | 2021-02-17 | tremor, numbness |
This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time...
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This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.
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| 61 | 2021-02-18 | weakness, hot flush, tremor |
Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs f...
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Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.
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| 61 | 2021-02-18 | tingling, numbness |
Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremiti...
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Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremities. There was concern for stroke so the patient came to the ER .The patient had received the second dose of the Pfizer vaccination 2 days prior. The patient received tPA and was treated in the ICU. After a short hospital course, the patient was discharged home.
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| 61 | 2021-02-18 | bell's palsy, facial paralysis |
Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesda...
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Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesday the 9th I noticed drooping to the right side of my face. Went to the ER and was told it was bells palsy
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| 61 | 2021-02-21 | difficulty speaking |
Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedr...
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Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedrol 125mg given IM, Epi pen administered x2 doses. Transported via ambulance to hospital.
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| 61 | 2021-02-21 | pain in extremity |
Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and...
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Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.
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| 61 | 2021-02-21 | weakness | Vomiting, rash, dizziness, weakness |
| 61 | 2021-02-21 | slurring |
patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of va...
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patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.
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| 61 | 2021-02-22 | weakness, difficulty speaking, pain in extremity |
Right side upper arm ache spread to right side of neck and into headache at back and top of skull. ...
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Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
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| 61 | 2021-02-23 | numbness | 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache |
| 61 | 2021-02-23 | speech disorder |
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is ...
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Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 61 | 2021-02-24 | throat numbness | Felt throat get numb and tight |
| 61 | 2021-02-24 | numbness, muscle spasms, tingling, paralysis |
Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset w...
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Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma
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| 61 | 2021-02-24 | tingling |
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder...
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Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
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| 61 | 2021-02-25 | paralysis | [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA) |
| 61 | 2021-02-25 | discomfort |
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe...
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chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
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| 61 | 2021-02-26 | numbness | Lips tingling, throat feels thicker, chest pressure, numbness in fingers. Evaluated by EMS-cleared |
| 61 | 2021-02-27 | numbness, facial paralysis, slurring |
In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was l...
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In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was leaking out when swishing from side to side. As the day progress, the right side of my mouth was getting number. The next morning Friday February 26, the right side of my face was numb, my speech was swirl, eating and drinking became challenging. I went to the emergency rom at Hospital where the team of doctors diagnosed me with Bell's Palsy. I was given Prednisone and Valtrex for a period of 7 days. Physical therapy as also being advised. The hospital advise me to follow up with my Primary Care Doctor (schedule for Monday March 1st), and to see a neurologist (waiting for an appt). As of today, the right side of my face has lost mobility.
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| 61 | 2021-02-27 | pain in extremity | cold symptoms, headache, sore arm, fatigue |
| 61 | 2021-02-28 | weakness |
Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have the...
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Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have these symptoms
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| 61 | 2021-02-28 | weakness, feeling hot | Rash, itchy around neck, hot, weak, drowsy, evaluated by EMS-transported to nearest ER |
| 61 | 2021-02-28 | pain in extremity |
arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips ...
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arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.
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| 61 | 2021-03-01 | tenderness |
Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:...
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Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.
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| 61 | 2021-03-01 | pain in extremity |
The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt ...
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The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal. Doctor visit - January 29, 2021 and February 5, 2021.and February 19th. They put me on high dose of Steroids - 20 mgs Prednisone daily and another round of blood thinner -ELIQUIS mg which helped me with pain and joints.
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| 61 | 2021-03-02 | flushing |
mild persistent headache all symptoms are mild flush...
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mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash
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| 61 | 2021-03-02 | pain in extremity |
pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the...
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pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours . The symptoms had subsided by 2 PM the next day.
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| 61 | 2021-03-02 | pain in extremity, feeling hot |
rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't go...
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rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.
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| 61 | 2021-03-02 | tingling |
shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip ...
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shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 61 | 2021-03-04 | pain in extremity |
Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and nee...
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Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and needing to vomit. Pt denied chest pain, difficulty breathing, and difficulty swallowing. Pt denied any similar reaction to vaccines. Pt stated that she had not eaten anything that day. Pt was offered EMS. Pt refused EMS. Pt was offered an adult dose of diphenhydramine. Pt agreed to take medication. First dose administered at 1222 by RN, second dose administered by RN at 1223. Pt stated at 1250 "I feel like I need to puke." Pt was offered EMS for a second time. Pt refused EMS. Pt left vaccination site with son at 1305 with a steady gait.
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| 61 | 2021-03-04 | slurring |
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso...
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Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
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| 61 | 2021-03-04 | tingling | opposite arm paresthesia |
| 61 | 2021-03-05 | difficulty speaking |
Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD d...
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Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!
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| 61 | 2021-03-06 | hot flush |
I had 2 minutes left from waiting my 15 min after receiving my first vaccine and all the sudden I go...
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I had 2 minutes left from waiting my 15 min after receiving my first vaccine and all the sudden I got very flushed/hot. And then light headed. It lasted about 5 minutes and I ended up staying an extra 30 more minutes. Then I was fine. No other problems.
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| 61 | 2021-03-06 | numbness and pain in extremities |
I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist ...
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I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.
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| 61 | 2021-03-06 | weakness |
On day 2, I developed confusion and could not focus making it impossible for me to complete my work ...
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On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
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| 61 | 2021-03-06 | pain in extremity |
With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., var...
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With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.
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| 61 | 2021-03-08 | pain in extremity |
I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had ...
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I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.
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| 61 | 2021-03-08 | difficulty speaking, burning sensation, tingling, flushing |
Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on...
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Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.
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| 61 | 2021-03-09 | pain in extremity |
Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consume...
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Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event
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| 61 | 2021-03-09 | seizure |
Patient received vaccination at 12:10. At 12:25, patient complained of tongue thickness. EMS called....
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Patient received vaccination at 12:10. At 12:25, patient complained of tongue thickness. EMS called. Difficulty breathing. Developed seizures. Epinephrine 0.3 administered. Seizures continued on/off for approximately 1234. Tongue swelling did improve. Transferred to hospital setting via EMS at 1245.
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| 61 | 2021-03-09 | pain in extremity | Sore arm and neck muscles, headache, chills, and fatigue |
| 61 | 2021-03-10 | weakness |
After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6...
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After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.
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| 61 | 2021-03-10 | difficulty speaking |
Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after ...
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Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight
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| 61 | 2021-03-10 | feeling hot |
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was...
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I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
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| 61 | 2021-03-10 | pain in extremity |
Slight headache and moderate arm pain ; both arm pain and headache gone by next morning; this is fo...
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Slight headache and moderate arm pain ; both arm pain and headache gone by next morning; this is for reporting purposes only; no care needed; all side effects abated in a reasonable time period.
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| 61 | 2021-03-10 | tingling, numbness |
Third and fourth fingers of left hand (vaccination arm) went completely numb for 2 hours. Massaged ...
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Third and fourth fingers of left hand (vaccination arm) went completely numb for 2 hours. Massaged for 2 hours and numbness changed to tingling for another 10 hours. Within 24 hours of vaccination time symptoms cleared.
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| 61 | 2021-03-11 | pain in extremity |
Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot g...
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Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot given in left arm. I?m at home so far nothing dead or hospitalized thank you
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| 61 | 2021-03-11 | pain in extremity |
February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a stro...
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February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.
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| 61 | 2021-03-11 | tremor | Shaking chills, high fever, severe body aches, nausea, diarrhea, vomiting, massive headache |
| 61 | 2021-03-11 | unresponsive to stimuli, weakness, flushing |
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
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| 61 | 2021-03-12 | pain in extremity |
Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and...
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Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and off for the first 2 days All of the above were relatively mild
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| 61 | 2021-03-13 | weakness, pain in extremity | 102 fever, severe left arm pain, weakness |
| 61 | 2021-03-13 | tingling, numbness |
Mild tingling and numbness on right side of face beginning 25 to 30 minutes after getting the vaccin...
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Mild tingling and numbness on right side of face beginning 25 to 30 minutes after getting the vaccine. Right eye began watering later in day. Noticed watering eye after taking 1/2 of a 10mg Zyrtec that evening. This morning, 3/14/2021, the watering right eye continues and the numbness and tingling in right right side of lips continue. The symptom to rest of right side of face appears to have dissipated. The best way to describe it is the feeling to face and lips is it feels similar to the feeling when Novocaine is wearing off.
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| 61 | 2021-03-13 | flushing | Redness, flushing, swelling |
| 61 | 2021-03-14 | burning sensation |
8 days after vaccine, developed burning sensation of skin which has changed locations in upper and l...
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8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.
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| 61 | 2021-03-14 | weakness, feeling hot |
9:00 p.m extremely tired, no energy, head ache body aches. Cold chills then hot. Weak thru Monday 3...
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9:00 p.m extremely tired, no energy, head ache body aches. Cold chills then hot. Weak thru Monday 3/15/2021 feeling better , just still feeling tired.
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| 61 | 2021-03-14 | tingling |
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was ...
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Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
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| 61 | 2021-03-14 | pain in extremity |
Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and ...
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Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.
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| 61 | 2021-03-14 | muscle spasms |
I haven't been able to walk nor stand without very sharp pain in my left lower side.I Been experienc...
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I haven't been able to walk nor stand without very sharp pain in my left lower side.I Been experiencing really bad spasms whenever i stand or sit down.
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| 61 | 2021-03-14 | tingling |
Paresthesia in lower legs bilaterally from mid calf to feet started 3d after second dose COVID vacc...
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Paresthesia in lower legs bilaterally from mid calf to feet started 3d after second dose COVID vaccine.. symmetric. Neuro exam was neg.
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| 61 | 2021-03-14 | unresponsive to stimuli |
Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her plac...
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Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.
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| 61 | 2021-03-14 | pain in extremity |
Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headach...
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Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.
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| 61 | 2021-03-15 | numbness |
3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TO...
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3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.
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| 61 | 2021-03-15 | flushing |
61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She...
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61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers.
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| 61 | 2021-03-15 | speech disorder |
A 61 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 m...
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A 61 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/16/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:42am Patient c/o "dizziness and mumbling noise." Patient alert, oriented, and verbal. Patient assessed in treatment area. Patient was treated/managed as follows: 11:44am VS BP 118/64, HR 67, RR 18, O2 sat 98% on room air. Patient denies shortness of breath or difficulty breathing. No swelling noted to face, mouth, or tongue. 11:59am VS BP 134/80, HR 70, RR 18, 97% on room air. Patient reports feeling better and symptoms have subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:08pm Escorted to car by sister and RN.
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| 61 | 2021-03-15 | breast pain |
Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten...
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Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten older but for 6 weeks after the second dose it felt as bad as it ever has. It kept me up at night and I had to take OTC pain relievers.
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| 61 | 2021-03-15 | weakness |
Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weak...
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Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.
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| 61 | 2021-03-15 | numbness |
Patient received vaccine and remained in pharmacy for 15 min. She had no adverse effects during that...
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Patient received vaccine and remained in pharmacy for 15 min. She had no adverse effects during that period. She then got in her car to drive home and within 5 min (20 min after the vaccine) she began having numbness in her face. She then drove back to the pharmacy to notify us of this. She denied any chest tightness, swelling of lips/throat, difficulty breathing. She was given 25 mg diphenhydramine and remained under our observation for another 15 minutes. Symptoms improved within 10 min after administration of diphenhydramine and drinking a bottle of water.
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| 61 | 2021-03-15 | flushing |
Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient c...
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Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident
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| 61 | 2021-03-15 | tingling, pain in extremity |
Progress Notes Subjective Patient is a 61 y.o. female who was seen at COVID vaccine clinic to...
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Progress Notes Subjective Patient is a 61 y.o. female who was seen at COVID vaccine clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience left arm paresthesia and aching. She denied rash, hives, SOA. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to skin changes. . Pt received injection to LUE, developed paresthesia to LUE, distal to injection site. ROS/PE unremarkable. No red flag findings to warrant further intervention. Clinically, superficial skin nerve involvement. Dismissed after period of observation. Previous Reactions: none Objective Vitals Vitals: 03/16/21 0843 BP: 121/84 Pulse: 74 Resp: 18 SpO2: 100% Physical Exam Vitals reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. No stridor. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion. Skin: General: Skin is warm and dry. Findings: No rash. Comments: No injection site erythema, rash Neurological: Mental Status: She is alert. Sensory: Sensory deficit present. Motor: No weakness. Comments: Paresthesia, mild without weakness Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt received injection to LUE, developed paresthesia to LUE, distal to injection site. ROS/PE unremarkable. No red flag findings to warrant furhter intervention. Clinically, superficial skin nerve involvement. Dismissed after period of observation.
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| 61 | 2021-03-15 | tingling, numbness |
Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting...
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Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot
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| 61 | 2021-03-15 | pain in extremity |
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ...
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nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
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| 61 | 2021-03-15 | pain in extremity | tinnitus beginning day after vaccine and ongoing, sore arm lasting 3 days |
| 61 | 2021-03-16 | numbness and pain in extremities | Left arm Ulner nerve neuropathy... dull ache |
| 61 | 2021-03-16 | flushing |
Patient received 1st Pfizer Covid vaccine (lot# ER2613 Exp 7/21) at 1300. At 1320 client informed nu...
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Patient received 1st Pfizer Covid vaccine (lot# ER2613 Exp 7/21) at 1300. At 1320 client informed nurse of flushed face feeling. First set of vials at 1320: pulse 65, blood pressure 132/74, respirations 18. Alert and oriented. No swelling noted or redness. Client denied shortness of breath, chest pain, dizziness. Per client similar feeling when she received flu shot. nurse offered client benadryl, client declined. Client informed she would be monitored for 30 min observation. Current medications: lisinopril, metformin, lovastatin, and vitamin D. No known allergies. 1335 vitals: pulse 74, blood pressure 130/72, respirations 18. Per client flushed face resolved. No other complaints at this time. Client alert and oriented. 1350 client completed observation, no complaints. Flushed feeling resolved. Last vitals: pulse 74, blood pressure 134/80, respirations 18. Advised client to follow up with primary provider before obtaining 2nd Pfizer dose. ER precautions given. Per client husband waiting in car. Client left facility with a steady gait.
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| 61 | 2021-03-16 | tenderness |
Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and...
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Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and left arm. States that left breast noticeably bigger that the right. Almost double the size from the swelling. Left arm having swelling that started on the inner aspect of the upper arm and has spread down to the elbow. Stated it is tender to the touch and having pain in muscle with moving arm. Not hot to touch. No redness, rash, bruising, shortness of breath, or tightness in throat. Offered an appointment for evaluation at the clinic, but patient declined and preferred to continue to monitor at home. Discussed that if swelling increases or persist to contact the clinic fo an appointment.
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| 61 | 2021-03-16 | tingling, hot flush |
Tingling all over; hot and flushed. No treatments needed. Improved on its own approx. 10 min after i...
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Tingling all over; hot and flushed. No treatments needed. Improved on its own approx. 10 min after it started.
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| 61 | 2021-03-16 | pain in extremity |
Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 mi...
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Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.
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| 61 | 2021-03-16 | tremor |
[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, trem...
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[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.
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| 61 | 2021-03-16 | inability to speak |
acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who...
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acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)
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| 61 | 2021-03-16 | weakness |
woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep...
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woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep. The entire next day I didn't feel well. Weak, slightly nauseous. All the symptoms lasted approximately 24 hours then I was back to normal. In case it matters. I believe I had Covid last February but it was prior to public knowledge and test availability.
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| 61 | 2021-03-17 | pain in extremity | Muscle pain in both upper legs |
| 61 | 2021-03-17 | feeling hot |
Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a g...
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Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a golf ball". Felt similar to GERD she had in the past but she has not had anything other than the shot to trigger this reaction
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| 61 | 2021-03-17 | tingling |
Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour ...
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Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour later, she took tylenol and currently 4-5h later her lip is tingling.
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| 61 | 2021-03-17 | hot flush | anxiety, lightheaded, flushes - resolved; VS 97%, HR 84 |
| 61 | 2021-03-18 | cold sweat |
At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV a...
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At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.
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| 61 | 2021-03-18 | facial paralysis, bell's palsy |
Bell's Palsy, right side. Onset 3/10/21. Facial palsy impairing eating/drinking/speaking/blinking/ey...
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Bell's Palsy, right side. Onset 3/10/21. Facial palsy impairing eating/drinking/speaking/blinking/eye closure unable/facial expression droop/unilateral lack of facial movement or facial expression. Reduced salivation.
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| 61 | 2021-03-18 | depressed level of consciousness |
Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m....
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Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m. 200 mg Some relief by 12p.m.march 19, 2021 Still dizziness, mild pain, cloudy thinking, not able to function
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| 61 | 2021-03-18 | weakness, tremor |
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by ...
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I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
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| 61 | 2021-03-18 | numbness |
My face became numb within 10 minutes of the injection. My throat started to close making it somewha...
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My face became numb within 10 minutes of the injection. My throat started to close making it somewhat difficult to swallow, but not to the point of having trouble breathing. It has been 12 hours since the injection and my face still feels numb, but swallowing is just starting to get a little easier. The numbness is mostly around my nose, cheeks and forehead.
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| 61 | 2021-03-18 | pain in extremity |
Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours...
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Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours and lasted 2 days.
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| 61 | 2021-03-19 | weakness |
Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat...
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Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.
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| 61 | 2021-03-19 | pain in extremity | Body aches Naseau and vomiting Chills Arm soreness |
| 61 | 2021-03-19 | weakness, burning sensation |
patient experienced burning sensation, nauseous, weakness few minutes (around 5-10mins.) after recei...
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patient experienced burning sensation, nauseous, weakness few minutes (around 5-10mins.) after receiving shot while seated and in waiting observation area.
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| 61 | 2021-03-20 | pain in extremity |
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte...
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1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
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| 61 | 2021-03-20 | pain in extremity | Fatigue, fever, chills and arm soreness for 24 hours |
| 61 | 2021-03-20 | pain in extremity |
Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous r...
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Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected
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| 61 | 2021-03-20 | pain in extremity | pain in arm, nausea, funny-dizzy type sensation |
| 61 | 2021-03-21 | pain in extremity |
COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CH...
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COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,
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| 61 | 2021-03-21 | pain in extremity |
Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol ...
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Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol 325 mg caplets and headache was gone within a couple of hours. Also arm was quite sore first night but much better 2nd night.
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| 61 | 2021-03-21 | weakness |
On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with...
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On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.
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| 61 | 2021-03-21 | unresponsive to stimuli |
Patient received vaccine then sat in the observation area. I was called over when she looked pale an...
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Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.
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| 61 | 2021-03-21 | tenderness |
States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/...
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States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/3/21 for evaluation. Reports bloodwork ordered. States she has been getting progressively worse with complaints of bilateral hip pain and discomfort to upper and lower back. Reports she had chills on 3/19/21 but no fever and has been in contact "daily" with PCP.
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| 61 | 2021-03-21 | pain in extremity, numbness |
The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vac...
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The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vaccine, immediately after injection, I felt numbness/tingling in lips, upper & lower & inside left of head/brain area, and also brief very sharp pains in my upper body randomly throughout my arms and chest. Intermittent sharp pain in center of chest.- scale 2/10 After the first 15 min, I sat outside the tent, and noticed a numbness in my left leg and foot and sharp pain in my left big toe - (03/21/21 left big toenail showed a light discoloration). Symptoms subsided within an hour, yet a residual minor numbness in my lips, continued, and intermittent sharp pain in center of chest. 2/10 On March 7, Sunday following the vaccine, at 11:00 am I felt definite numbness on the left side of my face. I touched it to determine if I could detect a sensation with my fingers, and I felt the numbness as I touched my face as well. My right side of my face was normal. Residual numbness to left face/head intermittently. including today more noticeable March 22, 2021.
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| 61 | 2021-03-22 | cold sweat, burning sensation |
12hrs after my 2nd Covid Vaccine I was sleeping got up out of my bed at 4am and the room was spinnin...
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12hrs after my 2nd Covid Vaccine I was sleeping got up out of my bed at 4am and the room was spinning. I layed back down and had a burning sensation in my chest and my hands and feet were clammy. Several hours later at 8am same exact reaction when getting out of bed. Over the course of 3 days I remained Lightheaded.
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| 61 | 2021-03-22 | feeling of body temperature change |
Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump unde...
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Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.
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| 61 | 2021-03-22 | weakness, feeling cold |
I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed...
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I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.
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| 61 | 2021-03-22 | tingling, numbness, feeling cold |
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was nor...
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Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
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| 61 | 2021-03-22 | numbness, tingling | Numbness and tingling in right hand |
| 61 | 2021-03-22 | tremor |
Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started a...
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Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.
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| 61 | 2021-03-22 | pain in extremity | Red, hot, sore patch on arm that developed 6 days after shot |
| 61 | 2021-03-22 | numbness and pain in extremities, pain in extremity, tingling |
Slight neuropathy over thumb into thumb - tingling to outright pain on touch. Is subsiding at this ...
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Slight neuropathy over thumb into thumb - tingling to outright pain on touch. Is subsiding at this time, but still present but less painful.
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| 61 | 2021-03-23 | seizure, tingling, burning sensation |
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ...
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BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
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| 61 | 2021-03-23 | feeling cold |
Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vacci...
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Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.
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| 61 | 2021-03-23 | feeling hot |
Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat bef...
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Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine
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| 61 | 2021-03-23 | facial pain |
I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. B...
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I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.
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| 61 | 2021-03-24 | pain in extremity, hot flush |
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh...
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Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
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| 61 | 2021-03-24 | pain in extremity, tenderness |
Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symp...
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Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.
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| 61 | 2021-03-24 | cold sweat, muscle spasms, pain in extremity |
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10...
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On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
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| 61 | 2021-03-24 | tingling |
Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds....
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Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds. Went to the emergency room and was stable at the time. Toward the latter part of the ER visit, I was given prednisone, Pepcid, and Benadryl. Have had no issues since then.
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| 61 | 2021-03-25 | pain in extremity |
3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed lat...
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3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.
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| 61 | 2021-03-25 | tingling |
3-25-21 2:50PM PT STATES 'LEGS FEEL TINGLING'. PT AMBULATORY GAIT BRISK/STTEADY. NO SOB, NO PAIN. GO...
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3-25-21 2:50PM PT STATES 'LEGS FEEL TINGLING'. PT AMBULATORY GAIT BRISK/STTEADY. NO SOB, NO PAIN. GOOD CAP REFILL TO FINGER TIPS. PT STATES SHE CAN 'FEEL THE MEDICINE ALL IN HER BODY'. A/O, PINK W/D, RESP REG WITH EASE.2:25PM TO EXIT PER WHEELCHAIR TO BE TAKEN HOME PER HUSBAND. NO ACUTE DISTRESS NOTED. 3-26-21 8:17AM PT STATES SHE 'FEELS FINE TODAY; NO TINGLIN IN HER LEGS'.
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| 61 | 2021-03-25 | pain in extremity |
Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressive...
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Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)
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| 61 | 2021-03-25 | tremor, weakness |
Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the che...
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Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.
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| 61 | 2021-03-25 | pain in extremity | Pfizer-BioNTech Covid-19 Vaccine EUA. Tiredness Chills Fever sore arm headache |
| 61 | 2021-03-25 | pain in extremity, cold extremities |
Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen he...
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Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.
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| 61 | 2021-03-26 | tingling |
Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe...
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Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe I also developed a minor rash. I took benadryl that night and slept fine. I felt the same way on 3/23/21 and took benedryl again. It seemed better 3/24/21 but came back on 3/25/21 and has continued today 3/27/21. After a walk outside with no jacket it is feeling better, but I can tell it's still there. Called my doctor on 3/23/21 and she recommended benadryl at night and allegra or claritin during the day. And ibuprofen and pepcid. I only have taken the benadryl. She advised not getting the second shot.
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| 61 | 2021-03-26 | feeling hot, hot flush |
Patient complained of hot flash and feeling "heat across chest." Pt refused ambulance treatment or t...
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Patient complained of hot flash and feeling "heat across chest." Pt refused ambulance treatment or transport to hospital ER. Patient would go to ER on their own.
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| 61 | 2021-03-26 | paralysis, weakness, inability to speak |
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p...
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Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
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| 61 | 2021-03-26 | tenderness |
Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later b...
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Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.
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| 61 | 2021-03-26 | weakness, night sweats, hot flush, feeling cold |
weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain,...
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weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea
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| 61 | 2021-03-27 | weakness |
3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high ...
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3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.
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| 61 | 2021-03-27 | difficulty speaking |
Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my...
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Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice. I was driving home at that point and considered turning back for medical advice (should have but did not). Over the next few hours itching sensation on my tongue, face including eyes, head and back. Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination. The symptoms were not severe but obviously I monitored them. Now 24 hours after the vaccination and still have some itching as described above. Throat is somewhat better. Eyes feel odd more than itchy at this point.
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| 61 | 2021-03-27 | tingling, numbness |
Left index finger from 2nd joint to too is numb and I frequently have tingling in my left index fing...
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Left index finger from 2nd joint to too is numb and I frequently have tingling in my left index finger and left thumb. This started right after I had the vaccine and is ongoing.
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| 61 | 2021-03-27 | pain in extremity, weakness |
total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning...
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total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon
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| 61 | 2021-03-29 | weakness |
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li...
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Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
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| 61 | 2021-03-29 | muscle spasms |
pain / swollen area where injection given. joint pain in every joint in my body - never had this bef...
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pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.
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| 61 | 2021-03-30 | tingling, feeling cold, muscle twitching, tremor, facial pain |
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ...
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Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
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| 61 | 2021-03-30 | tremor |
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet...
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Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
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| 61 | 2021-03-30 | discomfort |
Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse...
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Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse sweating; Never had low blood sugar before/Blood sugar crashed; Left side got tight; This is a spontaneous report from a contactable other hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 08:45 am (Batch/Lot Number: EN6203) at age of 61-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes. No pregnant. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication included semaglutide (OZEMPIC), metformin (METFORMIN), lisinopril (LISINOPRIL), all empagliflozin, linagliptin (GLYXAMBI) taken for an unspecified indication, start and stop date were not reported. The patient experienced left side got tight including brain/ brain was not cooperating with the eyes/ brain shaking, profuse sweating, never had low blood sugar before/ blood sugar crashed on 03Mar2021 09:30. Adverse event: Left side got tight including brain. After maybe 20 minutes while she was driving back. Blood sugar crashed and brain was not cooperating with the eyes. Brain shaking. Profuse sweating. Ate something when she got to work and started improving. Never had low blood sugar before. No treatment for events. The patient underwent lab tests and procedures which included blood glucose: low/crashed on 03Mar2021 09:30. The event outcome recovered in Mar2021.
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| 61 | 2021-03-31 | flushing, tingling, feeling hot |
My face became warmth /her arms felt slightly warm; My face became warm, red/flushed; My face became...
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My face became warmth /her arms felt slightly warm; My face became warm, red/flushed; My face became tight and tingling/her arms felt slightly tingling; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 61-year-old female patient (not pregnant) received first dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), in arm right on 08Mar2021 at 18:45 (at 61 years) at single dose for covid-19 immunisation. Medical history included high blood pressure and high cholesterol.Concomitant medications included atorvastatin, lisinopril, "Multi vit", calcium, ascorbic acid (VIT C) and ergocalciferol (VIT D), all taken for an unspecified indication, start and stop date were not reported. The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergy. On 08Mar2021 at 19:15 the patient's face became warm, red/flushed, tight and tingling and her arms felt slightly warm/tingling. All symptoms were gone within 2 hours of vaccine. No treatment given and patient recovered from all the events on 08Mar2021. No follow-up attempts are needed. No further information is expected
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| 61 | 2021-03-31 | facial pain, involuntary muscle movements |
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen...
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felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
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| 61 | 2021-04-06 | seizure |
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs ac...
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Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.
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| 61 | 2021-04-07 | weakness |
The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The...
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The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.
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| 61 | 2021-04-09 | pain in extremity, difficulty speaking |
feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of...
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feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
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| 61 | 2021-04-09 | pain in extremity |
not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her a...
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not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.
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| 61 | 2021-04-10 | facial paralysis, slurring, speech disorder, pain in extremity |
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press...
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I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
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| 61 | 2021-04-10 | facial paralysis, numbness, bell's palsy |
series of 2 covid pfizer vaccine 3/8/2021 and 3/29/2021 at pharmacy. next 24 hours achy body. Diag...
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series of 2 covid pfizer vaccine 3/8/2021 and 3/29/2021 at pharmacy. next 24 hours achy body. Diagnosed with bells palsy the morning of 4/2/2021. Numbness and drooping on right side of face. Unable to blink or smile. could not eat or drink. Went to local urgent care immediately and then to hospital emergency room. was checked for stroke, determined to be bells palsy. sent home with 7 day prescription of prednisone.
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| 61 | 2021-04-11 | burning sensation |
Later in the evening following injection, began noticing a burning/wearing along my spine itself. Ha...
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Later in the evening following injection, began noticing a burning/wearing along my spine itself. Had not ever felt that before. Took Aleve and and reg Neurontin dose and applied ice packs. Eased up after a couple of hours, but to be honest, I'm not looking forward to the second dose next week if I have a repeat performance. It won't stop me from getting the shot, just a bit concerned it might be worse. Has anyone else with nerve damage to spine or other areas noticed this effect? Just curious.
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| 61 | 2021-04-12 | numbness and pain in extremities, muscle spasms |
very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the...
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very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown. Information about on Lot/Batch number has been requested.
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| 61 | 2021-04-13 | feeling hot, burning sensation, pain in extremity |
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills...
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Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
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| 61 | 2021-04-14 | tingling | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 61 | 2021-04-14 | weakness | dizzy, weak, stomach pain, loose bowel movements, confusion, heart palpitations |
| 61 | 2021-04-17 | weakness | Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021 |
| 61 | 2021-04-17 | tremor |
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water...
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My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
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| 61 | 2021-04-17 | migraine |
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;...
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dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-04-18 | involuntary muscle movements, pain in extremity, muscle spasms, migraine |
anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely r...
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anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.
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| 61 | 2021-04-18 | slurring, numbness, speech disorder |
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef...
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having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 61 | 2021-04-18 | pain in extremity |
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a...
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tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
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| 61 | 2021-04-20 | pain in extremity, tremor |
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started...
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severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 61 | 2021-04-21 | numbness, tingling |
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the ...
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After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
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| 61 | 2021-04-23 | pain in extremity |
Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; ...
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Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; This is a spontaneous report from a contactable Other HCP. A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 13:30 (at 61-years age) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension, obesity, arthritis, copd and patient was allergic to bactrin, perfume. Concomitant medication(s) included doxepin (DOXEPIN); dapagliflozin propanediol monohydrate (FARXIGA); metformin (METFORMIN); temazepam (TEMAZEPAM); dulaglutide (TRULICITY). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.on 08Feb2021 04:00, The patient experienced sore arm and neck on the injection side of body.No treatment received for reported adverse event. The outcome of the event was resolved.
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| 61 | 2021-04-24 | bell's palsy |
Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient...
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Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 61 | 2021-04-24 | bell's palsy, pain in extremity |
Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating...
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Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.
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| 61 | 2021-04-24 | tremor |
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada...
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felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
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| 61 | 2021-04-24 | pain in extremity, muscle spasms, numbness |
she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hur...
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she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.
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| 61 | 2021-04-27 | burning sensation |
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai...
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I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
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| 61 | 2021-04-27 | weakness |
Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseo...
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Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-04-28 | bell's palsy |
Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consume...
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Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (61-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. The patient experienced left side of face is paralyzed, bell's palsy (Paralysis on the Left part of the Face) on 14Apr2021 with outcome of not recovered. No treatment was given.
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| 61 | 2021-04-28 | involuntary muscle movements, pain in extremity, tingling |
passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left ...
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passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 61 | 2021-04-30 | tingling |
heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a sponta...
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heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
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| 61 | 2021-04-30 | pain in extremity, weakness |
severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakn...
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severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-05-07 | tremor, pain in extremity, weakness |
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac...
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Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
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| 61 | 2021-05-07 | burning sensation |
Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with le...
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Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.
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| 61 | 2021-05-13 | pain in extremity |
1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blis...
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1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
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| 62 | 2020-12-31 | flushing |
REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77...
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REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.
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| 62 | 2021-01-01 | pain in extremity |
Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all t...
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Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all the symptoms subsided
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| 62 | 2021-01-02 | pain in extremity |
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours l...
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Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
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| 62 | 2021-01-03 | pain in extremity |
Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe ...
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Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.
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| 62 | 2021-01-03 | hot flush | face feel hot and flushed within 10 minutes after injection and lasted for about 2 hours |
| 62 | 2021-01-04 | pain in extremity |
fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore ...
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fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.
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| 62 | 2021-01-04 | pain in extremity | fatigue chills arm soreness |
| 62 | 2021-01-05 | pain in extremity, nerve pain |
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no...
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1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
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| 62 | 2021-01-05 | hot flush, feeling cold |
Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything e...
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Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay
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| 62 | 2021-01-05 | pain in extremity |
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing...
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swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-06 | muscle spasms, weakness |
I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in di...
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I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in diarrhea turning into bright red bleeding by the late morning on 12/25/20. I continued to bleed for hours (only when cramping) and ended up going to an ED for severe abdominal pain, bleeding, nausea and general weakness. The ED doctor said it was from internal hemorrhoids and the diarrhea and was not sure it was related to the Covid Vaccine and possible being an intestinal flu but I felt like I needed to report. I also had nausea and vomiting the evening of 12/26/20 lasting about 12 hours. It took me a few days of Zofran and Imodium to get it in control and the bleeding did stop by 12/27/20.
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| 62 | 2021-01-06 | pain in extremity | Very sore arm, unable to lift or move, stiff neck |
| 62 | 2021-01-07 | numbness |
10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on r...
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10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.
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| 62 | 2021-01-07 | pain in extremity |
Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day...
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Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 62 | 2021-01-07 | flushing |
My body had started itching and I didn't know why. I had not eaten anything new or changed any sha...
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My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.
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| 62 | 2021-01-07 | feeling hot |
Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and h...
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Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.
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| 62 | 2021-01-07 | flushing, feeling hot |
Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observatio...
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Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
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| 62 | 2021-01-07 | weakness |
Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore th...
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Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 62 | 2021-01-07 | weakness | body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue |
| 62 | 2021-01-09 | tremor |
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the...
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About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
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| 62 | 2021-01-10 | weakness |
Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The ...
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Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better
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| 62 | 2021-01-10 | feeling hot, burning sensation, hot flush, muscle spasms, tingling |
Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tinglin...
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Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.
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| 62 | 2021-01-10 | tremor, weakness |
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever...
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shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-01-11 | numbness |
20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of so...
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20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.
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| 62 | 2021-01-11 | hypersensitivity of all senses |
About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then ach...
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About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin. Took 2 acetaminophen, lots of blankets, able to sleep. No fever, woke up with same symptoms but milder.
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| 62 | 2021-01-11 | tingling |
Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted...
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Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted ~15 minutes. Symptoms in both feet lasted 5-6 hours and continue intermittently.
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| 62 | 2021-01-11 | feeling jittery |
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any att...
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Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-11 | feeling hot, facial pain |
became hot and dizzy and stated she had some facial pain. further assessment determined the respons...
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became hot and dizzy and stated she had some facial pain. further assessment determined the response to be a vasovagal response.
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| 62 | 2021-01-11 | tingling |
pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and ne...
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pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and needles sensation in hand, arm and left leg. NO rash, no itching, no notable other side effects; denies palipations, shortness of breath, no pain , no hives, no cough or swelling
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| 62 | 2021-01-11 | difficulty speaking, discomfort, pain in extremity |
some congestion that just came on; her arm was really aching after the injection; she started coughi...
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some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-01-11 | pain in extremity |
some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was real...
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some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
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| 62 | 2021-01-12 | pain in extremity |
1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itch...
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1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
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| 62 | 2021-01-12 | tremor, unresponsive to stimuli |
No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her bacl...
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No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found.
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| 62 | 2021-01-13 | feeling hot |
0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. E...
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0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED
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| 62 | 2021-01-13 | muscle spasms |
Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy ...
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Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.
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| 62 | 2021-01-13 | pain in extremity |
Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night af...
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Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night after shot. All gone by next morning with the exception of the headache, which is not as severe now.
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| 62 | 2021-01-13 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female pati...
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Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), intramuscular on 28Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included depression and anxiety. The patient was not pregnant and had no known allergies. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. On 29Dec2020, the patient experienced sore arm. The patient did not received therapy for the event. The most recent COVID-19 vaccine was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
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| 62 | 2021-01-13 | pain in extremity | Soreness in the arm , sore throat Mild fever, Pain at the injection site. Headache that |
| 62 | 2021-01-13 | feeling hot |
WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. B...
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WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. BP RANGING 140/60, O2 100. OBSERVED FOR 25 MINUTES. SYMPTONS REMAINS THE SAME SENT TO ER FOR FURTHER OBSERVATION.
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| 62 | 2021-01-13 | feeling cold |
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f...
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was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
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| 62 | 2021-01-14 | pain in extremity |
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ...
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Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
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| 62 | 2021-01-14 | pain in extremity | Body aches, chills, cough, headache, nausea, soreness and swelling of L arm pit. |
| 62 | 2021-01-14 | pain in extremity |
Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due t...
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Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.
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| 62 | 2021-01-14 | pain in extremity |
She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that e...
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She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine
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| 62 | 2021-01-15 | flushing, feeling cold, weakness |
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ...
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Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
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| 62 | 2021-01-16 | numbness |
Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted le...
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Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted less than an hour. Continued symptoms 48 hours after vaccine are moderate persistent headache, moderate fatigue. Feeling of not well. taking tylenol.
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| 62 | 2021-01-16 | pain in extremity |
chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fa...
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chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fatigue, congestion
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| 62 | 2021-01-17 | tremor |
Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right a...
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Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back
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| 62 | 2021-01-17 | pain in extremity |
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflam...
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I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
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| 62 | 2021-01-17 | tingling |
I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and ...
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I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and swollen lymph nodes under my arm and along the side of my breast and a tingly right hand. Fever broke early am on friday (1/8/2021). I was very fatigued and tired and still had a very tingly hand on 8th. Tingly slowly got better and I didn't notice it anymore on Wednesday ,13th. Fatigue was better by Sunday the 1/9th. I felt pretty much back to normal by 11th except for my hand. No treatment.
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| 62 | 2021-01-17 | pain in extremity |
Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not reso...
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Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not resolved 1/18/2021, not as painful now advil and massage therapist therapist treatment
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| 62 | 2021-01-17 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:0...
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Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with no soreness in arm or fever/headache.
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| 62 | 2021-01-18 | weakness |
Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going...
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Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.
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| 62 | 2021-01-19 | seizure |
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ...
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Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
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| 62 | 2021-01-19 | burning sensation | Severe burning sensation to left arm pit area |
| 62 | 2021-01-20 | discomfort |
"pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal,...
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"pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal, but more superficial. It is a general soreness with periodic stabbing pains." --still continuing after 5 days post vaccination
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| 62 | 2021-01-20 | flushing |
rosacea flare up; facial flushing; This is a spontaneous report from a contactable consumer (reporte...
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rosacea flare up; facial flushing; This is a spontaneous report from a contactable consumer (reported for himself). A 62-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1658), via an unspecified route of administration on 06Jan2021 12:15 at single dose at left arm for COVID-19 immunization. Medical history included asthma; osteoporosis; dry eye; Known allergies: Omnipaque CT injection fluid; environmental allergies including pollen and dust mites; rosacea he had many years ago including facial redness and burning. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously took denosumab (PROLIA) injection last taken on 06Aug2020. Facility type vaccine was Hospital. No other vaccine in four weeks. About eight hours after the injection the patient started having facial flushing and was advised to go to an emergency room. Patient saw Dr. (Name) at (Institution name) who prescribed Benadryl, Prednisone and Pepcid and the facial flushing subsided but came back the next day. The patient had been experiencing a recurrence of symptoms due to a rosacea flare up that he had many years ago including facial redness and burning. Adverse events start date on 06Jan2021 20:00 and resulted in Emergency room/department or urgent care. The patient didn't have COVID prior vaccination and didn't have COVID tested post vaccination. The outcome of the events was recovered with lasting effects.
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| 62 | 2021-01-20 | tingling, flushing, numbness |
tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand...
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tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.
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| 62 | 2021-01-21 | weakness, flushing, speech disorder |
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm t...
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A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
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| 62 | 2021-01-24 | weakness |
1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing...
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1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath
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| 62 | 2021-01-24 | muscle spasms |
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ...
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Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
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| 62 | 2021-01-24 | weakness |
Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal f...
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Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.
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| 62 | 2021-01-24 | tenderness | Pain and very tender to touch in left clavicle area. |
| 62 | 2021-01-24 | feeling hot | Tachycardia and hypertension feels hot and heart rate was high |
| 62 | 2021-01-24 | feeling cold, weakness |
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulenc...
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Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 62 | 2021-01-24 | pain in extremity |
arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten wo...
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arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen
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| 62 | 2021-01-24 | pain in extremity, muscle spasms |
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm...
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joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
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| 62 | 2021-01-25 | tingling |
Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy,...
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Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy, prickly, and were reddened. Denied SOB and denied chest pain. Benadryl was offered and taken, client felt better after that and was released, offered a ride home, but left with a friend.
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| 62 | 2021-01-25 | numbness, pain in extremity |
started last week feeling numbness in my right foot. Then went to my right leg and up to my right a...
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started last week feeling numbness in my right foot. Then went to my right leg and up to my right arm and hand . Then went to the left arm. Starting to have pain in my right hand and leg. The numbness grew daily. When i stand the numbness goes away and then when i lay down or sit down it comes back.
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| 62 | 2021-01-26 | tremor |
Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs....
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Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24
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| 62 | 2021-01-26 | pain in extremity |
The next day after the vaccine my arm was red and really painful. Each day the redness got larger a...
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The next day after the vaccine my arm was red and really painful. Each day the redness got larger and by friday it was near my elbow so I went to an Urgent Care. I was given a prescription for an antibiotic because they states infection had set in it and I also took tylenol and antihistimines to help with the pain.
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| 62 | 2021-01-26 | pain in extremity |
Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph ...
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Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.
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| 62 | 2021-01-26 | pain in extremity | bil arm pain, bil wrist pain, mild joint pain |
| 62 | 2021-01-27 | flushing, discomfort, involuntary muscle movements | Itching at injection site Flushing Tachycardia Syncope Unable to control BUE?s. Felt very heavy |
| 62 | 2021-01-27 | pain in extremity | Starting the day after the injection she is having very sore legs and it hurts to walk. |
| 62 | 2021-01-27 | pain in extremity | The day after the injection her legs are very sore and she is having pain walking. |
| 62 | 2021-01-27 | pain in extremity |
Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and uppe...
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Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and upper arm, positional discomfort. Pocket of fluid accumulation above right clavicle.
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| 62 | 2021-01-27 | flushing |
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 ...
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approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
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| 62 | 2021-01-27 | tremor |
approximately 10 minutes after receiving vaccine patient complained of fullness in throat and diffic...
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approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs
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| 62 | 2021-01-27 | migraine |
migraines; arm is sore where the injection; she could hear like blood going through her, and if she ...
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migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
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| 62 | 2021-01-28 | tremor | shaking, dizziness |
| 62 | 2021-01-28 | tremor | shaking, dizziness, felt bad right after injection |
| 62 | 2021-01-31 | inability to speak, numbness, tremor, weakness |
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point...
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(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
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| 62 | 2021-01-31 | numbness |
The vaccine was administered in my left arm, but my right hand started feeling numb. It only lasted...
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The vaccine was administered in my left arm, but my right hand started feeling numb. It only lasted about 30 mins and I was able to drive home, but it was very weird and unexpected.
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| 62 | 2021-01-31 | inability to speak |
she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transpor...
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she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.
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| 62 | 2021-02-01 | tingling, feeling jittery | Metallic taste to mouth Tongue feels funny Tingling/Fidgety to Fingers |
| 62 | 2021-02-01 | weakness |
racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60)...
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racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-02-02 | flushing |
Patient had some flushing, sweating and headache. Patient also had generalized itching over entire b...
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Patient had some flushing, sweating and headache. Patient also had generalized itching over entire body. no rash noted.
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| 62 | 2021-02-03 | muscle spasms |
101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headac...
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101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 62 | 2021-02-03 | weakness |
Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye a...
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Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.
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| 62 | 2021-02-03 | weakness |
chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weaknes...
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chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 62 | 2021-02-03 | tingling |
headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consume...
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headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
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| 62 | 2021-02-04 | weakness |
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible...
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Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
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| 62 | 2021-02-04 | numbness | Numbness in the left arm and left hand for about 2.5 days. Severity lessened as days progressed |
| 62 | 2021-02-04 | pain in extremity | soreness in arm, bad headache, nausea, itching on head, face and upper body. |
| 62 | 2021-02-04 | pain in extremity | soreness in arm, headache |
| 62 | 2021-02-05 | tingling |
Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus heada...
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Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.
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| 62 | 2021-02-05 | weakness | Fever x 3 days Weakness, fatigued, achy Urinary Incontinence day 1 Brain fog |
| 62 | 2021-02-07 | inability to speak |
I had difficulty forming thoughts and speaking in more than a few words at a time. I was aware I was...
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I had difficulty forming thoughts and speaking in more than a few words at a time. I was aware I was trying to think or respond, but felt somehow blocked from access and ability to think and speak. This experience lasted for about 28 hours, and then my access to cognition returned. By the way, I am a doctoral level psychologist for whom these skills are typically easy.
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| 62 | 2021-02-07 | pain in extremity |
Sore arm and mild chills 5 hours after injection. Moderate chills, fatigue, headache, sore arm 20 hr...
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Sore arm and mild chills 5 hours after injection. Moderate chills, fatigue, headache, sore arm 20 hrs after injection. Went to bed and slept 2 hrs, started feeling better 26-36 hours after injection. Completely recovered by 48 hrs.
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| 62 | 2021-02-07 | weakness |
Started to have weird body weakness sensation associated with mild nausea when I lay down at night. ...
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Started to have weird body weakness sensation associated with mild nausea when I lay down at night. Almost every night. As soon as I lay flat. Comes in waves. Causing me having problems falling asleep. Also happens when I tried to fall back to sleep. Mostly when I am about to fall asleep. During the day I am ok if I am upright. No fever or other symptoms. Getting insomnia from it every night.
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| 62 | 2021-02-07 | weakness |
extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthc...
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extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthcare professional (patient herself). A 62-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 16:15 at single dose for covid-19 immunization. Medical history included MS (multiple sclerosis); kidney disease. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included glatiramer acetate (COPAXONE) from 19Jan2021, escitalopram oxalate (LEXAPRO) and antihistamine, magnesium. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme weakness and an increase in her spasticity related to MS on 20Jan2021 12:00. Since the vaccination, the patient had not been tested for COVID-19. The events were reported non-serious. Outcome of events were recovering. No treatment was received for the events. Information on the lot/batch number has been requested.
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| 62 | 2021-02-07 | hot flush, pain in extremity | lots of nausea , hot flashes, sore arm |
| 62 | 2021-02-07 | tingling, pain in extremity |
slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tendern...
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slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tenderness in lower calf but no rash there. No treatment d/t it being mild reaction
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| 62 | 2021-02-08 | feeling hot, feeling of body temperature change |
I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt na...
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I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided. I still feel a little dizzy, very tired and switch from feeling hot to very cold.
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| 62 | 2021-02-08 | numbness |
Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progr...
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Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.
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| 62 | 2021-02-08 | pain in extremity |
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i...
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heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-02-09 | tremor |
Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date...
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Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
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| 62 | 2021-02-10 | feeling hot |
Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contac...
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Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included simvastatin and acetylsalicylic acid (ASPIRIN (E.C.). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypertension, tachycardia, feels hot and heart rate is high on 13Jan2021. The outcome of the events was recovering. The patient received treatment such as Amlodipine and lisinopril oral for the events.
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| 62 | 2021-02-10 | seizure | I had a mild seizure this morning that lasted about a minute. |
| 62 | 2021-02-10 | muscle spasms |
collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and s...
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collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
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| 62 | 2021-02-10 | feeling hot |
woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and ha...
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woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.
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| 62 | 2021-02-11 | tingling |
Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Receive...
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Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.
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| 62 | 2021-02-15 | migraine |
Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertig...
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Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.
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| 62 | 2021-02-15 | flushing | Pt reports heart racing, anxiety, and a flushed feeling with onset at 1800 |
| 62 | 2021-02-15 | flushing |
Pt. received vaccine at 1805 and Pt. came to RN stating she felt heart racing at 1828. RN took patie...
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Pt. received vaccine at 1805 and Pt. came to RN stating she felt heart racing at 1828. RN took patient to sit in observation area. Asked if any trouble breathing, stated no. RN noted patient with flushed face and red sclera. Patient placed on monitor with HR in 113, oxygen saturation 97% and blood pressure 186/108. Oral benadryl given at 1832 with water. Patient continue on monitor with HR in 107, at saturation 97% and blood pressure 186/103. 911 called at 1835 due to blood pressure issue and cont. flushed. EMT arrived 1842 and took over care. Pt. EKG done by them and then taken to ER at 1900.
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| 62 | 2021-02-16 | pain in extremity | Sore arm for one day. Rash started with pain left upper torso on day 7, diagnosed as shingles. |
| 62 | 2021-02-16 | facial pain |
Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth. Chewin...
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Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth. Chewing on back molars hurt. As time went on pain worsened and radiated into my cheek, left eye and left ear. ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises. These didn't help, so ~ a week after that, he gave me antibiotic. No improvement in symptoms until ~ a week after that. I saw pcp, as it felt like something was crawling inside my left ear. Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms. She suggested prescription-strength Naproxen for 10 days, which I did. the pain/ache has been mostly gone since completing the Naproxen. For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.
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| 62 | 2021-02-17 | weakness |
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu...
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The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 62 | 2021-02-18 | weakness |
I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and un...
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I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and uncontrollable vomiting. Suspects cerebral edema because of head ache and vomiting. Took 8 mg of dexmetholzone and Zofran. Neither were helpful. I took a shot of emetrex in case of a migraine. Vomiting has stopped but fatigue and weakness persists.
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| 62 | 2021-02-18 | tingling |
Patient received second dose of Pfizer COVID-19 vaccine today. While in recovery area, patient alert...
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Patient received second dose of Pfizer COVID-19 vaccine today. While in recovery area, patient alerted staff to feeling of swelling in the mouth. Patient was observed sitting in the recovery area in no acute distress, speaking without difficulty, no dyspnea observed. Patient reported feeling of tingling in her mouth/tongue and tingling in the left arm. Patient reported history of reaction to nuts that caused the same sensation in mouth. Denied history of anaphylaxis. Following reaction to nuts, the patient sought care at an Urgent Care facility where they administered benadryl and a steroid. Patient stated she was very nervous to receive this vaccine. I requested for an additional RN to observe patient and assess condition. Second RN assessed patient, discussed recommendation to visit emergency department, and escorted patient to the Emergency Department for treatment.
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| 62 | 2021-02-21 | facial pain, pain in extremity |
The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teet...
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The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
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| 62 | 2021-02-22 | tingling | Body aches, low blood pressure, tingling sensation in hands, symptoms lasted for a week. |
| 62 | 2021-02-24 | burning sensation |
Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also report...
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Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.
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| 62 | 2021-02-25 | flushing |
Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and ...
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Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73
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| 62 | 2021-02-25 | weakness, tremor |
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, t...
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body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.
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| 62 | 2021-02-26 | pain in extremity |
Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within ...
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Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.
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| 62 | 2021-02-26 | feeling cold |
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my ...
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For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
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| 62 | 2021-02-27 | tenderness |
Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are g...
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Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are getting better.
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| 62 | 2021-02-27 | pain in extremity |
Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with...
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Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with Tylenol
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| 62 | 2021-02-28 | difficulty speaking |
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar...
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Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
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| 62 | 2021-02-28 | tingling |
Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongu...
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Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongue and lip; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient received the second dose of the COVID-19 vaccine in the morning of 26Jan2021. From that afternoon on (26Jan2021), the patient had tingling in her tongue and lip. The patient did not have this side effect before. The patient was also feeling it on the lower part of her face today (28Jan2021) and is also feeling a tingling sensation on her fingertips. The patient was now (28Jan2021) experiencing a tingling sensation on her tongue, lips, and chin and it doesn't go. The patient wanted to speak with someone to ask if this is a normal side effect or if she should be concerned. The patient was asking what she can do about this. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 62 | 2021-03-01 | bell's palsy | Bell?s Palsy |
| 62 | 2021-03-01 | numbness | Throat tightness, dry mouth, numbness in L arm- evaluated by EMS-cleared |
| 62 | 2021-03-02 | weakness |
Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like...
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Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.
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| 62 | 2021-03-02 | pain in extremity |
One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the b...
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One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the body aches after the vaccine to be worse than having the virus itself. Second day after vaccine I noticed lymph node in my armpit to be very swollen. This was the same side of my body the shot was given. I am worried about getting the second dose but I am still going to get it.
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| 62 | 2021-03-03 | burning sensation |
0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALL...
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0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALLS MADE TO CLINIC AND PCP. I REFUSED TO GO TO EMERGENCY DEPT (HOSPITAL WAS TOTALLY FULL AND SOME). ALL DAY FEVER, NEVER BROKE. SAT. 102-103 SUN. WOKE FEELING FINE.
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| 62 | 2021-03-03 | pain in extremity | Extreme pain , weakness in right arm . Can?t lift arm . For two weeks already |
| 62 | 2021-03-03 | tenderness |
On or around December 22, I noticed pain in my left forehead as though someone had hit me with a bas...
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On or around December 22, I noticed pain in my left forehead as though someone had hit me with a baseball. The next week around the 29th, it got very noticeable - pain to the touch but no swelling. It continued. Between the first dose and second dose I didn't recover, it just stayed.
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| 62 | 2021-03-03 | weakness |
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm coul...
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Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
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| 62 | 2021-03-04 | tingling, numbness |
Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left a...
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Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left arm vaccine rm tingled and numb all the way to finger tips
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| 62 | 2021-03-04 | weakness, flushing |
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day...
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I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
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| 62 | 2021-03-04 | pain in extremity |
My husband also had the same vaccine at the same time but did not experience my symptoms as describe...
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My husband also had the same vaccine at the same time but did not experience my symptoms as described below: Vaccination was given very high on the should blade instead of upper arm of left arm. After the injection on 2/27/21 arm was mildly sore, but on the third day, there was more pain. On March 3, the pain was worse, very painful to lift or bend left arm, constant throbbing pain, there is no inflammation on the injection site but whole left arm especially the injection site is very very painful. To this day, March 5, 2021 the pain and throbbing persists, It is very painful to lift or bend the left arm. Will start take OTC CVS Ibuprofen 200 mg every 6 hours to ease the pain.
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| 62 | 2021-03-05 | weakness, feeling hot, cold sweat |
15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card,...
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15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.
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| 62 | 2021-03-05 | pain in extremity, flushing |
On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall ache...
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On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall aches and by evening had 101.5 temp and flushing of face along with mild headache. Tylenol taken along with warm shower and early bed. Woke in am with mild headache, loss of appetite. Felt better by 11am and after a cup of tea. By afternoon I felt 100% back to normal. No rashes or even a sore arm post vaccination in the days prior to this event on day 10.
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| 62 | 2021-03-05 | numbness, tingling |
Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) ...
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Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) Light headedness 2) Increase heart rate 3) Hands tingling 4) Upper Lip numbness
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| 62 | 2021-03-06 | throat numbness | back of throat felt numb |
| 62 | 2021-03-07 | tingling, numbness, pain in extremity |
About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and ...
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About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.
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| 62 | 2021-03-07 | tingling |
Patient complained of tingling in the neck, shoulder & arms. onsite EMS was called vitals BP 168/78 ...
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Patient complained of tingling in the neck, shoulder & arms. onsite EMS was called vitals BP 168/78 96% O2. Diphenhydramine 25mg orally griven. she was monitored, felt better, released againt medical advice.
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| 62 | 2021-03-07 | pain in extremity, feeling jittery |
Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable he...
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Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization. Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 62 | 2021-03-08 | hypersensitivity of all senses, weakness, pain in extremity |
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ...
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Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
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| 62 | 2021-03-08 | weakness |
Presented with weakness, generalized, and mild sweating. per patient " I typically get weak and swe...
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Presented with weakness, generalized, and mild sweating. per patient " I typically get weak and sweaty when I stand prolonged periods of time." patient states symptoms pre vaccination and continued after vaccine." patients symptoms improved after sitting in chair, no other symptoms.
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| 62 | 2021-03-08 | weakness |
Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of...
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Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours
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| 62 | 2021-03-08 | pain in extremity |
Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/...
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Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/2021; Called Dr. - telemed visit - 1/18/2021. I had not recovered from the adverse symptoms of first dose before getting second dose. I had the second dose on January 19, 2021 - had joint pain but I did so much easier than this first dose.
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| 62 | 2021-03-08 | muscle spasms |
Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after ...
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Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after vaccination requiring hospitalization.
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| 62 | 2021-03-09 | pain in extremity | Sore arm that lasted several days, took tylenol |
| 62 | 2021-03-09 | migraine |
Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea be...
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Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea began and lasted for 24 hours. Then, I began to have the chills and a migraine-like headache. The migraine is still continuing past 24 hours.
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| 62 | 2021-03-10 | tingling |
8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported ti...
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8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported tingling in fingers of right hand and burning of throat. CRNP notified and came to assess patient. Patient reported tingling in fingers of right hand but rest of right upper extremity felt fine. Having "upset stomach" and "throat soreness" which patient states she did not have prior to vaccine. She then stated her throat was burning. Able to drink water. Denied difficulty breathing or shortness of breath. Patient listed her allergies of Morphine and Percocet causing itching and scopolamine patch causing delirium. She reports taking all her prescribed medications this morning as well as 2 Tylenol. 9:29AM: Benadryl 25mg PO administered and patient continued to be monitored in observation area 9:44AM: CRNP reassessed patient and she stated she feels better and her throat was only sore and no longer burning 9:58 AM: CRNP reassessed. Patient states she is still feeling okay and would like to leave. MA walked with patient outside where patient got a taxi and was staying at her daughters house the rest of the day so she would not be by herself.
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| 62 | 2021-03-10 | feeling hot |
After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stro...
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After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
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| 62 | 2021-03-10 | cold extremities |
Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose dischar...
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Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.
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| 62 | 2021-03-10 | burning sensation |
Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortne...
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Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortness of breath,
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| 62 | 2021-03-10 | weakness | nausea, dizziness, weakness. Evaluated by EMS-Cleared |
| 62 | 2021-03-11 | pain in extremity |
Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 ...
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Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 hours and 40 minutes after injection. Wheezing...Began about 4 and a half hours after injection. Shortness of breath occurred overnight. 8 hours after injection. ...checked oxygen level at 93 Moderate widespread aching...8 hours after injection. 15 hours after injection...oxygen level at 88 15 hours after injection...Temperature of 99
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| 62 | 2021-03-11 | tremor |
Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees an...
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Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.
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| 62 | 2021-03-12 | tingling, tenderness |
I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on ...
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I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on March 11 and still today, March 13, I have had tingliness on my face and chin and nausea. It seems to be getting worse and not better. I have been taking Benedryl. Is this normal or what should I do?
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| 62 | 2021-03-12 | flushing |
Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it...
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Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it was injected, and tingling. No shortness or breath or chest pain, patient was removed from cell and taken to the observation area, her chest was red and flush. her blood pressure at 1145 was 178/122 and heart rate 89 and pulse ox 95% in her let wrist, patient was placed on litter and laid down, she was observed . Follow up blood pressure at 1208 on her left wrist was, 167/112, HR 87, pulse ox was 99 on room air. Blood pressure check in her right wrist was 175/99 . Patient stated that her symptoms were resolving with additional observation. Patient was then placed on the edge of the bed for additional time and patient was released from observation at 1215.
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| 62 | 2021-03-13 | muscle twitching |
About 2 AM all of the muscles in my arms, legs and torso started twitching. This continued until ab...
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About 2 AM all of the muscles in my arms, legs and torso started twitching. This continued until about 5 AM, at which time I dozed off. When I woke up (about 7:30 AM), I noticed that all of the twitching had stopped. It never returned.
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| 62 | 2021-03-13 | breast pain, tenderness |
After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morni...
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After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender
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| 62 | 2021-03-13 | pain in extremity |
The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain w...
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The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.
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| 62 | 2021-03-14 | flushing |
Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under ja...
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Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw. Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM. A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.
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| 62 | 2021-03-14 | feeling cold, tenderness |
Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of sk...
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Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.
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| 62 | 2021-03-14 | tenderness, pain in extremity |
The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30...
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The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30pm, I got nauseous, a really bad headache and had really bad chills. I got two heating pads out, one for my arm and one to warm me up. It lasted ?til about 3am and then it was over. My arm is still a little tender, but otherwise I am back to "my normal".
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| 62 | 2021-03-14 | pain in extremity |
she felt something in her foot (right foot) under the toes like she had sept on something like the l...
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she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.
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| 62 | 2021-03-15 | pain in extremity |
Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting...
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Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.
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| 62 | 2021-03-15 | pain in extremity, hot flush |
Got the vaccine, and a few minutes or so she felt like a funny sensation up around/left side of her ...
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Got the vaccine, and a few minutes or so she felt like a funny sensation up around/left side of her head, like something was crawling inside her head, like something bulging. Throbbing type pressure sensation. She did not say anything at the time, and went home. She went home and still felt the feeling on her head. She did also notice that her hot flashes got a little worse than usual. Had a sore arm for a couple of days. When she laid down at night she could feel that sensation/throbbing in her head a little more. She put a ice compress on it but could feel it a little bit, not as bad as it was as of today 3/16/21. She called the pharmacy on Wednesday 3/10/21 who advised her to go see her PCP. She went to the UC last Friday 3/12/21 as she could not see her PCP. They checked her scalp and did not see any rashes or anything, and advised her to take Motrin intermittently with Ibuprofen. She also told her to check back if she continued to have problems, but she decided to see her regular PCP.
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| 62 | 2021-03-15 | pain in extremity |
Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after...
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Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after the vaccine, was diagnosed by a doctor as "superficial thrombophlebitis, pain swelling in leg. Treatment of ibuprofren started. Wondering if I should take my second shot which is scheduled for MArch 26
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| 62 | 2021-03-15 | pain in extremity | Slight arm soreness initially. 12 hours later developed nausea, chills, body aches, temp of 100.5. |
| 62 | 2021-03-15 | pain in extremity |
These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore ...
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These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching. Still hot to the touch and red.
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| 62 | 2021-03-15 | pain in extremity |
Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurt...
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Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurts. Legs especially hurt.
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| 62 | 2021-03-15 | flushing | flushing, tongue tingling, redness chest, neck and cheeks. Evaluated by EMS-Cleared |
| 62 | 2021-03-15 | numbness | right side of face numb |
| 62 | 2021-03-16 | pain in extremity |
Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? ac...
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Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? across at injection site. Fatigue and body aches beginning 4 days after vaccination.
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| 62 | 2021-03-16 | slurring |
Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Cal...
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Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Called her neuro doctor on 3-1-21 he said to take her to the eye doctor so I did. They told me her eyes are dry to put eye drops in. Called her neuro next day he told me to take her to the ER. They diagnosed her with Graves Disease and now she is showing symptoms of Graves Disease. She has never had any problem with her Thyroid. Had blood work done back on Jan 20th 2021
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| 62 | 2021-03-16 | numbness | body warm, numbness left side of face,blood pressuure spick |
| 62 | 2021-03-17 | burning sensation, tingling |
About 4 hours after injection I started feeling pins and needles in my hands and then I started fee...
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About 4 hours after injection I started feeling pins and needles in my hands and then I started feeling it all over. It would come and go. A few days later it felt like burning, stinging and itchy. I?m still getting it but not as frequently. There?s no rash. I?m concerned about getting a 2nd vaccine. I know this could be related to the vaccine or anxiety. I saw blogs that this happened to others after the Covid vaccine.
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| 62 | 2021-03-17 | cold sweat |
After my fourth day (March 16th) of the vaccine this is what happened: Day started great and about ...
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After my fourth day (March 16th) of the vaccine this is what happened: Day started great and about 1pm started having severe diarrhea with intervals of 15 to 30 minutes apart. At approximately 2:30pm I started having projectile vomiting. All of this lasted until approximately 5pm, I was also very clammy and cold, no fever. by 7pm I felt somewhat normal. The next day I felt great! It was an experience I've never had before so that why I am sending this to you!
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| 62 | 2021-03-17 | muscle twitching, tremor |
March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extrem...
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March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extremities associated with difficulty walking due to the "jerking twitching"..
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| 62 | 2021-03-17 | pain in extremity, nerve pain, burning sensation |
tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertip...
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tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-03-18 | pain in extremity |
About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swolle...
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About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swollen every day for about 5 days. I had aches and pain all over, itchiness, headache, joint pain over the next week. Around the 22nd, it stopped. It took almost 10 days for me to feel somewhat normal.
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| 62 | 2021-03-18 | weakness |
Extreme headache. Could not lift head off of pillow. Light bothered me and made headache worse. So t...
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Extreme headache. Could not lift head off of pillow. Light bothered me and made headache worse. So tired could hardly stay awake.
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| 62 | 2021-03-18 | weakness, pain in extremity |
I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper a...
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I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.
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| 62 | 2021-03-18 | pain in extremity | Sore left arm Exhaustion Fever Headache |
| 62 | 2021-03-18 | pain in extremity | sore throat, dizziness, right eye pain, diarrhea, leg pain, fatigue, soreness at site area |
| 62 | 2021-03-19 | feeling hot, inability to speak | Hot, dizzy, feel like I going to pass out could not talk differently breathing |
| 62 | 2021-03-19 | pain in extremity |
My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the wa...
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My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the way down to my hand at time. My armpit is swollen and painful. The pain goes thru my underarm down to my hand. The pain makes it difficult to sleep. Tylenol doesn't take the pain away. At first I thought the pain was a side effect to the initial vaccine, but it got worse as time went on. Finally I researched it on line and saw that lymph nodes have been reported as swelling due to the vaccine.
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| 62 | 2021-03-19 | tingling | tingling in legs, nausea, headache, pressure in chest, back pain |
| 62 | 2021-03-20 | cold extremities, tingling, numbness |
Patient complaints as COVID vaccination as following; numbness, tingling, and cold sensations on lef...
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Patient complaints as COVID vaccination as following; numbness, tingling, and cold sensations on left 4th finger. After 15-20 minutes later, the patient had full sensation, color, ROM, and temperature on all 4 fingers. No further medical intervention needed.
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| 62 | 2021-03-20 | cold sweat |
woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1p...
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woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1pm broke out in cold sweat and became nauseated. 1:30 began vomiting. Remained nauseated, cold sweats off and on, multiple episodes of vomiting until 5pm
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| 62 | 2021-03-21 | cold sweat |
3/22/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screeni...
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3/22/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate. And clammy Assessment : Time of assessment 1613 Alert and oriented. Actions taken: Vs taken at 1613 BP- 121/69 P- 72, water offered Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/22/2021 3:36 PM 0.3 mL 12/11/2020 Intramuscular
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| 62 | 2021-03-21 | burning sensation, flushing |
After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after ...
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After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after 96 hours bumps more pronounced with some small pimple sized and covering a larger portion of the cheeks . It was also warm to the touch and beginning to feel like a mild sunburn. It stayed this way until Monday morning , 6 days later when I contacted my doctor. Doctor instructed me to take benedryl and see if this relieves it. Also informed me to take benedryl before I get my next injection. It is still ongoing at this level at the middle of day 6 as I am submitting this report.
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| 62 | 2021-03-21 | pain in extremity | Chills, nausea, aches, sore arm |
| 62 | 2021-03-21 | feeling hot |
Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours ...
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Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours later swelling was gone.
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| 62 | 2021-03-21 | tenderness |
Large lump appeared in left armpit 3 days after Vaccine It is very sore to touch and hurts most of t...
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Large lump appeared in left armpit 3 days after Vaccine It is very sore to touch and hurts most of the day. Went to Dr. Told me to keep taking Tylenol and using a pain rub (Hemp Vana) on it. Said it should die down in 4 to 6 weeks.
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| 62 | 2021-03-21 | tenderness |
Sever body aches including to touch skin throughout body. Sever pain shooting through body and musc...
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Sever body aches including to touch skin throughout body. Sever pain shooting through body and muscle. Severe headache and lethargy. Swollen painful lymph node under left arm pit that continues...
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| 62 | 2021-03-21 | pain in extremity | Very sore arm, fever and fatigue |
| 62 | 2021-03-21 | tingling |
complained of tingling in legs and itchy throat approximately 10 minutes after injection. Monitored...
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complained of tingling in legs and itchy throat approximately 10 minutes after injection. Monitored in observation area and when symptoms didn't resolve after 30 minutes, transferred to triage 1 for observation and evaluation. 1330-BP 186/82, p-118, O2 sats- 98% Declined a Zyrtec 1337 BP 156/72, p-60, O2 sat-99%, no further tingling in legs. No scratchiness in throat. Denies difficulty swallowing, no shortness of breath, no swelling in mouth, lips or tongue. Evaluated by Dr., Patient released to home. Reviewed symptoms to seek care for- shortness of breath, trouble swallowing, difficulty breathing
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| 62 | 2021-03-21 | tremor, hot flush |
high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog...
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high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.
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| 62 | 2021-03-21 | seizure |
pt had a seizure while waiting on observation area she reports her family was with her and told her ...
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pt had a seizure while waiting on observation area she reports her family was with her and told her about seizures medical staff alerted and 911 called. pt awoke from seizure and declined to go to ER reports she felt okay. unclear if generalized seizure.
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| 62 | 2021-03-22 | pain in extremity, nerve pain |
1 week after 2nd dose, on 1/24/21, woke up with stiff neck (left rear cervical area) which proceeded...
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1 week after 2nd dose, on 1/24/21, woke up with stiff neck (left rear cervical area) which proceeded with nerve pain down left shoulder and arm. After 2 weeks with no relief OTC remedies, saw PCP on 2/8/21, who ordered PT. Saw chiropracter for neck pain on 2/8/21. Weekly PT appts x 5 weeks, no relief. Saw PCP again on 3/5/21 for extreme nerve pain in arm. Prescribed Tramadol for pain, put on 11-day course of Prednisone. Some pain relief, but not resolved. MRI ordered and completed on 3/19/21 with no findings except arthritis. Now being referred to Spine Clinic for further diagnosis.
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| 62 | 2021-03-22 | tremor |
62 years old female called to report an adverse reaction after she received her first Pfizer dose on...
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62 years old female called to report an adverse reaction after she received her first Pfizer dose on 03/18/2021 @1330. patient report that on 03/20/2021 @1030 she developed dizziness, lost balance, fever and shaking. patient denies any allergies. patient reported that she is taking Lyrica, Lamictal for facial nerve pain. and amitriptyline to help her sleep. patient was instructed to drink plenty of water and keeping hydrated to help with the dizziness, patient was instructed to take tylenol to help with the fever. patient was instructed to seek medical attention if the symptoms got worse.
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| 62 | 2021-03-22 | facial paralysis | Left side of face completely paralyzed |
| 62 | 2021-03-22 | pain in extremity | Low fever, body aches/chills, exhaustion, sore arm |
| 62 | 2021-03-22 | seizure | Patient had a seizure blood pressure and pulse elevated. Known history of seizures. Went to ER |
| 62 | 2021-03-22 | tingling, numbness | Throat tightness, R arm tingling, Rt side facial numbness. Evaluated by EMS-Cleared |
| 62 | 2021-03-23 | feeling cold | Chills, nausea, passed out, muscle aches |
| 62 | 2021-03-23 | feeling hot, flushing, burning sensation |
Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got...
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Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got better after 15 minutes. Tingling of lips & tongue better after 1 hour, but still present. Face felt hot & flushed 40 minutes after shot. Also had some "burning" of veins in wrist . Metallic taste continues.. Some itching of face.
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| 62 | 2021-03-23 | flushing, feeling hot |
I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer ...
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I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.
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| 62 | 2021-03-23 | hot flush |
Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot fl...
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Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot flashes (more intense than usual) and occasional fatigue (usually starting around mid-afternoon) and lasting for three days, starting about 24 hours after second dose. No fever.
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| 62 | 2021-03-23 | speech disorder |
Pt received 2nd dose pfizer @ 0800 Pt found by observer @ 0802 with increased WOB, pale skin, pt una...
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Pt received 2nd dose pfizer @ 0800 Pt found by observer @ 0802 with increased WOB, pale skin, pt unable to speak in full sentences due to SOB. Lungs sounds assessed and noted to be wheezy, x1 does Epi administered, 911 called. 0803- BP 100/60, HR-100, RR 32, SPO2- 92, Pt breathing improved after 2 mins, pt verbalizes decreased WOB. Second set of vitals- BP 110/70, HR 106, RRR- 20, SpO2, 96%. 0809- AMR arrives and assumes care of pt
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| 62 | 2021-03-23 | pain in extremity | Sore arm Fever 102 F Headache |
| 62 | 2021-03-23 | tingling, numbness |
Waited 15 minutes and seemed fine. Drove away and began to get a numb/tingling lips and face. Initia...
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Waited 15 minutes and seemed fine. Drove away and began to get a numb/tingling lips and face. Initially lasted 10 minutes, but came back periodically during the day.
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| 62 | 2021-03-23 | hot flush, tremor |
Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minut...
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Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minutes got a full body heat flush and starting shaking all over. Heart beating fast and having some pain in chest. Drove to her work place and was assessed by MD and RN on staff. BP was 220/120, pulse over 100. She took a Claritin and was monitored in the work place. She became lethargic and chest pain continued so she went to the closest Emergency Room.
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| 62 | 2021-03-24 | pain in extremity, tremor |
2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, n...
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2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.
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| 62 | 2021-03-24 | tremor, weakness |
Initially light headed and sever headache. The next day, developed severe skin burning sensation al...
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Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.
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| 62 | 2021-03-24 | muscle spasms |
Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger t...
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Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger tips, hand cramping off and on for 2 days. Not able to eat. Had to start taking Zofran on 4th day to be able to start slowly getting soft food in system.
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| 62 | 2021-03-24 | weakness |
Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site....
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Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site. The patient was hypertensive (175/97) with a FSBG of 152 mg/dl. EKG demonstrated NSR, rate 86bpm, no ST elevation. EMS transported the patient toEmergency Department for further evaluation. In the ED, the patient reported dizziness, lightheadedness, near-syncope, aching headache, generalized fatigue, and weakness. Physician administered 25mg PO Meclizine. Upon reevaluation, the patient reported improvement and was discharged with diagnoses of Vaccine reaction and Dizziness.
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| 62 | 2021-03-25 | depressed level of consciousness |
Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept ...
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Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept 5 hours. Spouse woke me up to eat. I was polite and took a few bites. Went to bed @ 10 pm. The next morning I woke in the fetal position and COULD NOT MOVE! Called husband for help. He lifted me to the sit up position by my rib cage. Very difficult to move for 4 days. Had Gammagard treatment on March 16. 2021. That was a mistake, I guess. I could not even think clearly enough to try to fill out this form.
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| 62 | 2021-03-25 | flushing |
FELT FLUSH, DEVELOPES RASH ON CHEST. GIVEN IV DIPHENHYDRAMINE AND NORMAL SALINE BOLUS. DECLINED EMS ...
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FELT FLUSH, DEVELOPES RASH ON CHEST. GIVEN IV DIPHENHYDRAMINE AND NORMAL SALINE BOLUS. DECLINED EMS AFTER RECEIVING ADVICE FROM ER DR, NP AND EMS
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| 62 | 2021-03-25 | pain in extremity |
On 3/25 I had a sore arm with firmness around the injection site. Today I woke up very early with f...
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On 3/25 I had a sore arm with firmness around the injection site. Today I woke up very early with fever and chills and feeling pretty ill. Urinated and crawled into bed and put electric blanket on high until I felt warm. Got up about 7:00 and took my temperature and it was about 100. Then it varied between 99 and 102.5 all day. Had blurred vision and body aches and bad headache and nausea. .Took Tylenol or hydrocodone which helped with keeping temp closer to 100 but I?d fall asleep and forget to take Tylenol and it would go back to 102. I didn?t have anyone to drive me that I felt comfortable enough to risk exposure in case it was an actual illness and not the vaccine. I considered calling an ambulance but decided to wait and see if I could get my temp under control. This evening I?m at 100 again (I just took it again) but thought my fever had broken as I didn?t feel I was radiating heat like I felt when it was 102. My normal temp is usually around 97. I haven?t taken anything Tylenol or hydrocodone since about 3:00 but I will take just plain Tylenol now.
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| 62 | 2021-03-25 | tremor |
Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to ...
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Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to be lessening now
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| 62 | 2021-03-25 | tingling, weakness |
Tingling in lips and swelling, tingling traveled under both eyes, up into her head, it also traveled...
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Tingling in lips and swelling, tingling traveled under both eyes, up into her head, it also traveled down her right arm. She experienced weakness on her right side, She also thought her ears swelled to the point that she had to remove her hearing aids.
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| 62 | 2021-03-26 | night sweats |
I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night ...
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I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night sweats, severe fatigue, loss of appetite, head aches, and blisters on my skin. I have not been exposed to Mononucleosis that I know of and have been isolated from the public because my husband had not been vaccinated yet. Mononucleosis has a 4-6 week incubation period which is when I took my second vaccine shot
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| 62 | 2021-03-26 | tingling |
Prickly rashes on ankle and back of thigh, started ~9 hrs after injection. I tried to describe rash...
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Prickly rashes on ankle and back of thigh, started ~9 hrs after injection. I tried to describe rashes in detail, but was kicked out of site after spending time to describe them carefully. Plese call if you need more info
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| 62 | 2021-03-26 | hot flush |
Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme v...
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Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme vertigo/non- stopped vomiting for a few hours. Zofran from doctor stopped vomiting. Excessive sweating chills and hot flashes But no fever. Could not walk on own for 24 hours. Still experiencing dizziness if stand up or bend over too fast. Ringing in ears.
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| 62 | 2021-03-26 | flushing |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications
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| 62 | 2021-03-27 | pain in extremity |
1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. ...
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1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. on 3/26/21. Woke up the next morning at 4:00 a.m. with pain in my arm and basically feeling terrible. I had pain in the arm, soreness under arm, achy and severe joint pain all over, headache over my eyes, extreme fatigue, chills on and off, a few instances of sweating, Generally felt really sick. Appetite decreased. The next night woke up in the middle of the night sweating, then later in the night with chills. Aching and pain in joints was miserable. By noon on 3/28/21 was feeling a lot better, still tired and arm just sore. Stomach still a little off.
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| 62 | 2021-03-27 | feeling jittery, feeling hot |
3/28/2021 (patient) was observed post Covid-19 immunization for 30 minutes based on pre-vaccinatio...
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3/28/2021 (patient) was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Hot, jittery. Assessment : Time of assessment 1332 Alert and oriented. And anxious Actions taken: VS taken at 1332, BP- 199/147, P- 123, O2- 100%,placed on stretcher, offered water and drinking, patient reports that she took her BP meds late today, VS recheck at 1344- BP- 182/73, P- 90, O2- 100%, symptoms residing, daughter in room. 1350 BP- 175/72. P- 89, O2- 100%, at 1400, BP- 174/89, P- 64, discharge with daughter at 1402. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 1:27 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8733
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| 62 | 2021-03-27 | pain in extremity |
Very itchy right eye, for 2.5 days, (same length of time as arm soreness), followed by sudden onset,...
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Very itchy right eye, for 2.5 days, (same length of time as arm soreness), followed by sudden onset, noticeable vision loss with diagnosis of epiretinal membrane and vision loss from BCVA from 20/20 or 20/40
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| 62 | 2021-03-28 | pain in extremity | 1 week later, left calf pain, SOB |
| 62 | 2021-03-28 | numbness |
Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, ...
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Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN
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| 62 | 2021-03-29 | muscle spasms |
diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 ...
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diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was Health Department. The outcome of the events were recovering.
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| 62 | 2021-03-30 | pain in extremity |
I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes...
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I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; my neck arm and shoulder were killing me; my neck arm and shoulder were killing me; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; This is a spontaneous report from a contactable consumer. A 62-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 18:45 (at the age of 62 years old) as SINGLE DOSE for covid-19 immunization. The facility in which the vacation was given was a Pharmacy or Drug Store. Medical history included hypertension, blood cholesterol increased and covid-19 (prior to vaccination). The patient has no known allergies. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient 'was' diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 04Mar2021 at 00:00, The patient experienced flu like symptoms for 2-3 days, Pain chest, Neck pain, Arm pain and Pain. No Treatment was given. The clinical course was as follows patient had the normal flu like symptoms for 2-3 days. Then noticed that her neck arm and shoulder were killing me. Now it is the whole upper left quadrant of her body. This includes the chest area around where my heart is. It is very painful and I do cry out with a pain sound if I move a certain way. No treatment was given for the events. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 62 | 2021-03-30 | pain in extremity, numbness |
Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body a...
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Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-03-30 | tingling |
difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide...
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difficulty swallowing; jaw got very sore like it started popping out of joint and couldn't open wide/large dime size knot on the left side of jaw right at tmj area; jaw got very sore like it started popping out of joint and couldn't open wide; tingling down left leg down to toes, left leg only/tingling on the left leg; large cyst on the left side of her jaw; sore right jaw with clicking sounds; large dime size knot on the left side of jaw, right at TMJ area;hardness; pimple; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN8203; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. There were no medical history and concomitant medications. On 04Mar2021, reports getting the vaccine on 04Mar2021 and has had a large cyst on the left side of her jaw, sore right jaw with clicking sounds and tingling on the left leg, an hour and a half after. Also reported difficulty swallowing. Reported that she had reactions, not immediately, but 1 hour and 15 minutes after the vaccine. Caller reports a large dime size knot on the left side of jaw, right at temporo mandibular joint (TMJ) area. Injection was on left side. Caller reported that minutes later, her jaw got very sore like it started popping out of joint, and couldn't open wide. She also states that she had tingling down the left leg, down to the toes, left leg only. States this all happen pretty much right at the same time, maybe 5-10 minutes of each thing happening. She is at home with grandson. She was on hold for a while already. Weird reactions, not the common ones. States that she is not going to take the second vaccine, is afraid to take it. At this point, it is just a hard knot (described as a large dime size knot), and he (the doctor) said to take a Benadryl, which she did. Knot, hardness resolved gone by 06Mar2021, but a pimple remained for 7 days. The outcome of the event jaw disorder, jaw pain, was recovered on an unspecified date, for the event tingling of extremity was recovered on 04Mar2021, for the event large dime size knot on the left side of jaw, right at TMJ area;hardness was recovered on 06Mar2021, while unknown for the other events. No follow-up attempts possible. No further information expected. Batch/lot number already provided; Sender's Comments: Considering the close temporal association (reportedly, the reactions occurred hour and 15 minutes after the vaccine), a causal association between the reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-04-10 | tremor |
2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days...
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2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days also then had chills hand tremors loss of appetite nausea this continued for 2 more months. I went to Urgent care and on March 26 then found a clot in my right lung. I am on warfin now and none of these symptoms did I have prior to the vaccine. I had 5 covid tests to see if I had COVID but all the tests were negative.
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| 62 | 2021-04-11 | depressed level of consciousness |
Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19...
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Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose
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| 62 | 2021-04-13 | one side paralysis |
Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER...
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Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER, admitted to NeuroScience ICU. Diagnosed with small blood clot and small bleed in brain--- dural venous sinus thrombosis. The neurology team said this was very unusual and very rare in this part of brain--where the blood flows back to the heart from the brain. They did alot of tests on every part of my body looking for the cause and found nothing. They think it was vacine induced and repoted it to the CDC. Left leg and arm weakness remains with no changes yet. Now taking blood thinner and doing physical therapy
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| 62 | 2021-04-14 | weakness | Death SHORTNESS OF BREATH WEAKNESS - GENERALIZED |
| 62 | 2021-04-14 | weakness |
N17.9, N18.9 - Acute kidney injury superimposed on chronic kidney disease (CMS/HCC) E87.5 - Hyperkal...
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N17.9, N18.9 - Acute kidney injury superimposed on chronic kidney disease (CMS/HCC) E87.5 - Hyperkalemia R06.00 - Dyspnea, unspecified type R53.1 - Weakness R73.9 - Hyperglycemia E11.10 - DKA, type 2, not at goal (CMS/HCC)
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| 62 | 2021-04-15 | numbness |
Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continue...
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Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.
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| 62 | 2021-04-17 | weakness, pain in extremity, tingling |
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ...
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eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 62 | 2021-04-17 | weakness, night sweats |
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs...
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passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
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| 62 | 2021-04-18 | weakness |
Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache ...
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Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache that tylenol couldn't dull, fatigue and weakness, weak shoulders could keep them raised for more than a few seconds, swelling of abdomen, rapid fluid retention, lack of appetite, chest felt constricted, nose bleeds, black sticky stools Treatment: 2 units of blood, ferrouse sulfate IV, saline IV, protonix IV, endoscopy Outcome:health back to normal, after blood transfusion, will continue to take pantoprazole for six weeks and Iron Note: used to have ulcers years ago due to H. Pylori bacterium suspect Pfizer mRNA vaccine interacted with H. Pylori antibodies as has been found in other patients with H. Pylori.
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| 62 | 2021-04-23 | unresponsive to stimuli |
-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -N...
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-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -No reactions were observed at the pharmacy (within 15 min waiting period) following either covid-19 vaccine (1st dose administered 8am on 3/26/21 -Left Deltoid) -When asked (4-16-21) how she tolerated the 1st dose, Patient reported minor side effects (mild Headache, tiredness) but had no reservations about receiving the 2nd dose. No additional information.
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| 62 | 2021-04-24 | numbness |
Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower par...
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Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower part of face; throat constriction, lasted for 45 minutes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 10:00 AM as single dose in right arm for COVID-19 immunisation. The patient's medical history included auto-immune disease, RA, Hashimoto. Patient had no prior allergies except to bee venom. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 60 minute after the shot, throat constriction, lasted for 45 minutes. On 20Mar2021, the patient experienced severe anaphylactic-like reactions to foods. Patient experienced throat swelling, closing, numbness of lower part of face which resulted in emergency room visit and physician office visit. Reactions are muted since taking antihistamines but persisted even on 08Apr2021. Adverse events treatment included Allegra, Zyrtec. All allergy tests were negative. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not recovered.
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| 62 | 2021-04-24 | tremor, seizure, pain in extremity |
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking,...
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She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot. Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,. The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021. The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
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| 62 | 2021-04-24 | feeling of body temperature change, weakness |
cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose;...
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cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.
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| 62 | 2021-04-24 | weakness |
heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt...
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heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt her heart racing; Heart rate goes up and down; could not do anything and was laying in bed or on the couch; white blood cell count is higher than it should be; has allergies to medications but not what was in the Pfizer shot. She adds that maybe she had a reaction to the chemicals in there.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6206 and expiry date: was not provided), via an unspecified route of administration, in arm left, on 10Mar2021 at 03:30 PM, as a single dose for COVID-19 immunization, at hospital. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19, before the vaccination, however, results not provided. The patient has not been tested for COVID-19, after the vaccination. Patient's medical history included breast cancer survivor, chronic lymphatic leukemia. Patient had known allergies with penicillin and sulfa. Concomitant medications included calcium, colecalciferol (D3), macrogol 3350 (MIRALAX), multi vitamin, and ibuprofen (ADVIL DUAL). The patient previously took ciprofloxacin (CIPRO) and morphine: and had allergies with both drugs. The patient reported that on 11Mar2021, her heart was fluttering and beating it out of her chest with elevated heart rate which goes up and down. She also felt her heart was racing. It was very erratic. The highest heart rate was 130 (non-sustained). It was started since morning after the vaccination and was still happening now and wanted to know that it was a normal side effect. She had a cardiac work up and couldn't find anything however, everything was normal. Her heart rate went up to 130, 140, 150 and went to 80. This was happened over a period of 5 or 6 days. She felt like she could not do anything and was lying in bed or on the couch for three days. Her white blood cell count was higher that it should be. She went to her regular doctor who did the EKG, however, results not provided. Further, she went to a Cardiologist and they did another EKG and wore a monitor for a week and did echocardiogram and blood work all results were normal. She was wondering, if this could possibly be a side effect from the vaccine because it did occur in the morning after she got vaccinated. She also reported that she had allergies to medications but not what was in the vaccine and that maybe she had a reaction to the chemicals in the vaccine. She was supposed to get the second shot of vaccine which was scheduled on 31Mar2021 and had concerned about getting the second shot because she had some allergies and now this happened. She was very frightening and thought that she was going to die. It was very scary for her. The product complaint was not reported. The patient did not receive any treatment for the event. Outcome of the event Allergy to chemicals was unknown and for all other events it was recovered on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.
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| 62 | 2021-04-27 | tenderness, pain in extremity |
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee...
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Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
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| 62 | 2021-04-27 | inability to speak |
I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got li...
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I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 62 | 2021-04-30 | facial paralysis, numbness, pain in extremity, electric shock sensation |
blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo ...
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blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo and dizziness; really bad vertigo and dizziness; facial palsy; vision in her right eye got fuzzy; face got numb on the right side; hot electrical nerve zinging entire right arm, right shoulder blade and right calf; sore arm; feel sick; hangover; vomiting; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 16Apr2021 11:15 (Batch/Lot Number: EW0162) as single dose (at the age of 62-years-old) for COVID-19 immunisation. Medical history included anaphylaxis: carries an epi pen, and has allergies to wasps. The patient also took unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient got her first vaccine dose on 16Apr2021 and reported having a history of anaphylaxis and carried an epi pen. She stayed at the vaccination facility for an hour and a half and she got facial palsy and her vision in her right eye got fuzzy. Then her face got numb on the right side. It took 4 hours for it to go away but by dinner she felt ok. She added that immediately after the shot (16Apr2021), she experienced hot electrical nerve zinging entire right arm, right shoulder blade and right calf that lasted 30 minutes; blurry vision right eye started 15 minutes after shot, recurred off and on for 6 hours; facial palsy on right side that started about 30 minutes after shot that lasted 4 1/2 hours; vertigo/dizziness that started 7 hours after the shot; and blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85. She filed a report online when her symptoms began to subside. A couple hours later, she began to feel sick again and went to bed. When she walked to her mailbox, she was feeling ok but when she bent over to get the mail, that made it all worse. She woke up feeling as if she had a hangover and reported vomiting right away after getting out of bed. She had really bad vertigo and dizziness. She also had a sore arm (unspecified which arm) and stated that she was "experiencing everything on the freaking list." The patient wanted to know if this was normal and asked if she should get the second dose. She was advised that if she had a severe allergic reaction after a previous dose of the vaccine, she should not get the Pfizer-BioNTech Covid-19 vaccine. She also wanted to know if her symptoms got worse over the weekend and wanted to know what were the signs if she should go to the hospital. The patient did not receive any treatment for the adverse effects. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient recovered from hot electrical nerve zinging entire right arm, right shoulder blade and right calf 16Apr2021 11:45; face got numb on the right side on 16Apr2021 15:15 and facial palsy on 16Apr2021 16:15. The outcome of the remaining events was unknown.
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| 62 | 2021-04-30 | feeling hot, seizure, weakness, pain in extremity |
felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell h...
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felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.
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| 62 | 2021-04-30 | flushing |
hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and th...
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hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and throat; swelling of lips, tongue and throat; known allergy clearly the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer. A 62-year-old female consumer reported that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) intramuscular into the left arm on 01Apr2021 at 09:00 am (at the age of 62-year-old) at single dose for COVID-19 immunization. Concomitant drugs included vitamins only. Known allergies included all shellfish, Percocet, adhesives on bandages. On 01Apr2021 at 09:15 am the patient experienced facial flushing, hives on face, swelling of lips, tongue and throat. As per reporter the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient was treated with IV with epi, solu-medrol, prednisone and Benadryl. The patient reported as known allergy 'clearly the Pfizer Covid vaccine'. The patient recovered from the events on an unknown date.
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| 62 | 2021-05-03 | weakness, pain in extremity |
She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy;...
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She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.
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| 62 | 2021-05-04 | sensory loss, numbness, throat numbness |
Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and...
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Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.
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| 62 | 2021-05-05 | weakness |
Patient received COVID-19 vaccine on 1/28 and 1/6/2021. On 4/25 patient developed cough, back pain,...
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Patient received COVID-19 vaccine on 1/28 and 1/6/2021. On 4/25 patient developed cough, back pain, and weakness/fatigue. Tested positive for COVID. Treated with monoclonal antibodies.
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| 62 | 2021-05-06 | flushing |
I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, wai...
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I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, waited a bit hoping it would go away and when it didn?t we alerted the EMT on site. My lungs sounded ok so I was instructed to go home and take Benadryl. On the way home my tongue began to swell and get a tingling sensation. My cheeks became extremely hot and had a red rash. I ended up having to take two Benadryl to get the symptoms to go away.
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| 62 | 2021-05-07 | weakness |
Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too ...
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Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-05-07 | weakness |
Fever up to 100 (degree) Farenheit; Tiredness; Feeling weak; This is a spontaneous report from a con...
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Fever up to 100 (degree) Farenheit; Tiredness; Feeling weak; This is a spontaneous report from a contactable physician reporting for herself. This 62-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number EN5318, intramuscularly on the left arm on 03Feb2021 at 11:00 AM (at the age of 62-year old) at single dose for COVID-19 immunization outside a church. Relevant medical history was none. Historical vaccination included first dose of the same vaccine intramuscularly in the left arm on 13Jan2021 at single dose for COVID-19 immunization. Family history included an aunt died from encephalomyelitis disseminate in 1975. Concomitant medication included cyanocobalamin (VIT B12) from 2019 and ongoing orally. On 04Feb2021 at 06:00 AM the patient experienced fever up to 100 degree Farenheit, tiredness and feeling weak. On 02Feb2021 the patient had a PCR test for COVID with negative result. On 03Feb2021 at 3 PM the patient received metamizole (NOVAMISULFON) 1 tablet orally to treat an unspecified event. Treatment for the above events was reported as "No". The patient recovered from the events. The patient commented "Expected side effect of vaccine, personally easy to react to vaccines with fever". Follow-up attempts are completed. No further information is expected.
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| 62 | 2021-05-07 | pain in extremity |
right foot is in a lot of pain feels like its broken, barely can walk; right foot is in a lot of pai...
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right foot is in a lot of pain feels like its broken, barely can walk; right foot is in a lot of pain feels like its broken, barely can walk; This is a spontaneous report from a contactable consumer (the patient). This 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in in the right arm in Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. The patient's medical history and concomitant medications were not reported. The patient previously had blisters on the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in in the right arm in Mar2021 at 14:30 (at the age of 62-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 03:00 AM the patient experienced her right foot is in a lot of pain feels like its broken, barely can walk. She considered these events resulted in disability. No treatment was received for the adverse events. The clinical outcomes of the "right foot is in a lot of pain feels like its broken, barely can walk" were resolving as of 24Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
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| 62 | 2021-05-11 | hot flush, migraine |
Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing e...
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Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events. Follow-up attempts are completed. Information about lot/batch number cannot obtained.
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| 62 | 2021-05-11 | nerve pain, cold sweat |
To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; ...
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To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-01-01 | difficulty speaking |
Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively...
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Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.
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| 63 | 2021-01-04 | pain in extremity |
6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she start...
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6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.
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| 63 | 2021-01-05 | numbness |
My right face, around the cheek/mouth area had a feeling like when you get Novacaine and lasted abou...
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My right face, around the cheek/mouth area had a feeling like when you get Novacaine and lasted about an hour.
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| 63 | 2021-01-05 | facial paralysis, numbness, tingling |
right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and nee...
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right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing. On 31Dec2020 04:15 PM, the patient reported "Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop." The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.
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| 63 | 2021-01-06 | tingling |
Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the E...
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Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the ED due to a shellfish allergy for which she carries an epipen. Pt experienced mild symptoms c/w allergic reaction after receiving Pfizer COVID vaccine #1. Symptoms included tingling lips and sensation of swollen tongue. She was given Diphenhydramine 50mg PO. Condition did not progress and her symptoms resolved within about one hour of oral Diphenhydramine. She was observed for 3 hours and discharged to home with prescriptions for an epipen and benadryl. Employee states - "15 min after the vaccination my hands got tingly on the palms. 5-10 min after that the front of my lips were tingly then my tongue felt thick. I also got a headache They gave me benadryl pills in the ED and within 10 min tingling on my lips went away and my tongue felt normal. My headache also went away." She was discharged from the ED back to work and reports no other symptoms.
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| 63 | 2021-01-06 | night sweats |
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, c...
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Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
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| 63 | 2021-01-06 | muscle spasms |
This is a self report: two days after the vaccine I developed severe heart burn ( something I have ...
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This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.
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| 63 | 2021-01-07 | tingling |
Patient experienced paresthesia in the face from the eyebrow down to the chin within a few hours aft...
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Patient experienced paresthesia in the face from the eyebrow down to the chin within a few hours after the first dose of the Pfizer COVID-19 vaccine. Aside from the paresthesia under the eye that lasted approximately 48 hours, the remainder of this effect slowly improved within hours. The patient has no contributing medical conditions, chronic or short-term medication use, or drug allergies.
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| 63 | 2021-01-07 | pain in extremity |
Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the i...
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Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.
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| 63 | 2021-01-07 | pain in extremity |
heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontan...
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heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm on 30Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included pulmonary embolism (PE's x 2) and left nephrectomy for kidney cancer (CA). Concomitant medications included apixaban (ELIQUIS), losartan and hctz. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 18:00, the patient experienced heart rate in the 120's which lasted 15 minutes while at rest and left arm deep aching for 2 days. Outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 63 | 2021-01-08 | pain in extremity |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.
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| 63 | 2021-01-09 | tremor |
I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I hav...
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I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG
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| 63 | 2021-01-09 | pain in extremity |
Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slight...
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Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.
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| 63 | 2021-01-10 | weakness | Extreme fatigue/weakness body aches, especially hips |
| 63 | 2021-01-10 | tremor |
severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is ...
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severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is - should I get the #2 dose in light of the robust antibody response to #1. Could it be even worse?? Any information on this?
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| 63 | 2021-01-10 | weakness | weakness, fever, cough |
| 63 | 2021-01-11 | weakness |
I felt ok right after the injection but about 2 hours later I started experiencing a pressure headac...
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I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
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| 63 | 2021-01-11 | pain in extremity |
Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old fe...
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Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK 9231, via an unspecified route of administration in the right arm on 31Dec2020 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history included hypothyroidism, hypertension, high cholesterol, penicillin allergy; all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan, levothyroxine/liothyronine (NP THYROID), simvastatin, vitamin B, vitamin c [ascorbic acid], colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 01Jan2021 at 12:00, the patient experienced a sore right arm. Treatment was not received for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the sore right arm was resolved on Jan2021.
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| 63 | 2021-01-12 | tremor |
Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors ...
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Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.
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| 63 | 2021-01-12 | one side paralysis, face paralysis |
She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face ...
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She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.
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| 63 | 2021-01-12 | pain in extremity |
horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat;...
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horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-12 | pain in extremity, muscle spasms |
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both leg...
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temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.
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| 63 | 2021-01-13 | pain in extremity | Developed DVT in left leg around January 9. Developed pain, redness and swelling in left calf |
| 63 | 2021-01-14 | facial paralysis |
Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21, 2nd dose on 1/10/21 immediate numbne...
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Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21, 2nd dose on 1/10/21 immediate numbness in mouth and tightness in throat which triggered bells palsy symptoms immediately
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| 63 | 2021-01-14 | weakness | Fever, chills, headache, body aches, nausea, generalized weakness |
| 63 | 2021-01-14 | pain in extremity | Left arm severe pain, swelling, redness, and hot to touch |
| 63 | 2021-01-14 | tingling, numbness | numbness tingling in both arms into hands |
| 63 | 2021-01-17 | pain in extremity |
Severe chest pain ( like a vice was tightening around chest). Lasted 20-25 minutes. No nausea. Had...
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Severe chest pain ( like a vice was tightening around chest). Lasted 20-25 minutes. No nausea. Had to go to ER, Labs all negative, could find no reason for pain. Went home after approximately 3-4 hours in ER. Also arm pain x 1 month now
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| 63 | 2021-01-18 | feeling cold |
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10)...
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10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94). 10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at 10:34am - Temperature: 37 degrees Celsius. 10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale. 10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90. Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
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| 63 | 2021-01-18 | weakness |
12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided ...
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12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided weakness; transported to ER. I couldn't lift left leg, 1" off bed and couldn't do the push pull. 1-2 hours symptoms lasted. Everything went back to normal, sent home. 12/30 huge flare up with fibromyalgia; lasted couple days. Flare up occurred the following week. Getting second shot 1/19/2021
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| 63 | 2021-01-18 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patien...
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Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.
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| 63 | 2021-01-18 | tingling | Bottom lip tingling and both hands tingling |
| 63 | 2021-01-18 | weakness, pain in extremity |
Injection was administered very high on left arm(at joint level). It felt like a nail went in, and t...
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Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine. Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.
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| 63 | 2021-01-18 | tingling |
Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in...
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Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in hands and feet.
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| 63 | 2021-01-18 | flushing | Systemic: Nausea-Medium, Systemic: Flushing-Medium |
| 63 | 2021-01-18 | cold extremities |
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade f...
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from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees) treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol 3 days post vaccine- headache, nausea (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
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| 63 | 2021-01-19 | pain in extremity |
12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,hea...
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12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,headache,body aches,very sore arm 36 hrs after vaccine swollen lymph nodes under rt arm, temp 99.8
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| 63 | 2021-01-19 | tingling |
Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before le...
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Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic. She returned 2 hours later with anxiety, hyperventilation and paresthesia. Vital signs showed improvement before symptoms resolved.
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| 63 | 2021-01-19 | feeling hot, pain in extremity | felt warm, slight fever, headache, very sore arm. Dizzy. |
| 63 | 2021-01-20 | facial paralysis |
Bells Palsy; This is a spontaneous report from a contactable Other HCP (patient). A 63-year-old fe...
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Bells Palsy; This is a spontaneous report from a contactable Other HCP (patient). A 63-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL1284) intramuscular at single dose at left arm on 29Dec2020 16:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, thyroid disorder, high cholesterol, fibromyalgia, allergy to sulfur drugs and codeine. The patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient previously took codeine and experienced drug hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced bells palsy on 11Jan2021. The event resulted in Emergency room/department or urgent care. The event bells palsy has been treated with steroids. Post vaccination, the patient has been not tested for COVID-19. The outcome of event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 63 | 2021-01-20 | feeling cold | Pain at injection site, headache, chills muscle aches, joint pain, restless |
| 63 | 2021-01-20 | flushing | Patient experienced "flushing" after receiving her Dose 2. Symptoms resolved within 15 minutes. |
| 63 | 2021-01-20 | pain in extremity |
The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection w...
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The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.
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| 63 | 2021-01-20 | tingling, muscle spasms |
severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour...
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severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour and a half then I still feel tired I ended up going back to sleep for another 4 hours; almost like pin pricking; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included blood pressure, thyroid disorder and hormone level abnormal. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation, with no side effects. The concomitant medications was reported Levothyroxine at 5 ug 1x/day for thyroid; atenolol, chlorthalidone (ATENOLOL AND CHLORTHALIDONE) 50/ 25 for Blood pressure; estradiol (ESTRACE) at once a day For hormones. blood pressure management. Patient had second shot on Friday (08Jan2021), she was fine until about 09Jan2021 2:30 in the morning then patient woke up with severe cramps and quick stools, she had about 4 dumps throughout the day she was trying to work and then by 4:30, 5 O'clock patient was having enough drinking water and a whole lot of fluids, stools along with a lot of severe cramping, so she ended up calling in today for work which was definitely not her. Then patient went ahead and she have slept 'many parts of today' (not clarified), she slept like, wake up probably about an hour, hour and a half then she still feel tired ended up going back to sleep for another 4 hours. Patient worked only 3, 3 and a half hours a day because of her health, she had 7 or 8 round so don't normally sleep long but she was healthy. 'Problem is' (voice feeble), now that patient had gotten herself a little more relaxed patient was having a bunch of spasms with legs and arms and almost like pin pricking, so said just to call and let you know she tried but couldn't do it online." Treatment was received for events, took the Tylenol 500 (unit not probed) 1 tablet, took that at 4 O'clock.. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-01-21 | pain in extremity |
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou...
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Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
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| 63 | 2021-01-21 | feeling cold | Chills, diarrhea. Improved. |
| 63 | 2021-01-21 | feeling hot |
I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, abou...
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I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, about 15 hours after receiving the vaccine, I woke up from my sleep suddenly, with an acute episode of chest tightness, cough, severe running nose and lacrimation. I did not have hives or lip/throat itching or swelling. I felt a little warm in the face. I took Ventolin inhaler two puffs twice 30 minutes apart + Aller-flo nasal sprays. I began to feel a bit better and then took Benadryl 25 mgms (because of my history of Angioedema) around 2:30 am. I feel better now, which is 12 hours after onset of episode, but had to take Ventolin inhaler this morning for a bit of chest tightness. I do not have a history of asthma, but have had seasonal allergies in past years. But if this is seasonal allergy, it is very unusual, since I have never had an acute episode like this without any early milder symptoms. And I haven't needed Ventolin in a couple of years. I am now concerned about taking the second dose.
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| 63 | 2021-01-21 | pain in extremity | pt. experiencing arm pain, vomiting, shortness of breath, dizziness |
| 63 | 2021-01-22 | hot flush | Throat and back of tongue swelling, hot flushes in head and face. High blood pressure and pulse. |
| 63 | 2021-01-23 | pain in extremity |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. Incident Report filed at the hospital. MRI done on 1/20/2021-saw Doctor on 1/22/2021 who diagnosed adhesive capsulitis.
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| 63 | 2021-01-24 | pain in extremity |
Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extr...
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Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.
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| 63 | 2021-01-24 | weakness |
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s...
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Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
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| 63 | 2021-01-24 | pain in extremity |
lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle cap...
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lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation. Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin. Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
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| 63 | 2021-01-24 | pain in extremity |
right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, ...
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right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.
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| 63 | 2021-01-25 | muscle spasms |
Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imod...
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Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imodium, motrin, soft bland diet. Six + episodes of diarrhea in one hour on 1/21/2021 with significant cramping. Went to ER. Received fluids and IV Zofran. CBC and CMP WNL. Stool test also done--negative. Discharged. Severe diarrhea morning of 1/22/2021. Missed work on 1/21 and 1/22. Diarrhea and abdominal cramping continued intermittently. Worked Monday. Stool samples provided. C.Diff negative. Lactoferrin positive. Enteric bacterial panel negative. CT of abdomen scheduled for 1/27/2021
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| 63 | 2021-01-25 | pain in extremity | Sore arm, dizziness, nausea , lightheaded |
| 63 | 2021-01-25 | migraine |
Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days...
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Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
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| 63 | 2021-01-25 | pain in extremity | headache, body ache, chills, fatigue, sore arm, Nausea |
| 63 | 2021-01-26 | difficulty speaking |
: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning...
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: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.
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| 63 | 2021-01-26 | tremor | Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches, |
| 63 | 2021-01-27 | discomfort |
Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been ...
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Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.
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| 63 | 2021-01-27 | pain in extremity |
fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. F...
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fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. Fever persisted from 1/7/21 to 1/10/21. Seen in ER 1/9/21 with T 101.9 again & workup (-) for bacterial infection /sepsis , COVID neg, flu neg.
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| 63 | 2021-01-28 | feeling hot, tingling, numbness |
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest...
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8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-28 | throat numbness |
My face got red and warm. A single hive developed on my left jaw. After a few minutes later my thr...
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My face got red and warm. A single hive developed on my left jaw. After a few minutes later my throat and tongue started to feel numb like I had gone to the dentist and gotten a novacaine shot. We went to a pharmacy immediately and got some Bennedryl which took the symptoms away within the hour.
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| 63 | 2021-01-28 | weakness, pain in extremity |
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac...
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Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
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| 63 | 2021-01-28 | weakness, cold sweat |
starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved -...
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starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening
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| 63 | 2021-01-29 | tingling, numbness |
10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling &...
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10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling & numbness followed & also went to my hands. 9 days later I still have some residual tingling, mostly in my feet.
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| 63 | 2021-01-29 | feeling cold |
Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high o...
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Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high of 100.0 F, joint pain, headache, fatigue. Lasted about 24 hours, improved by second day after shot with minor fatigue for another day, by 3rd day felt normal.
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| 63 | 2021-01-29 | flushing |
The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes af...
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The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes after receiving the injection, she felt itchiness of the ears, facial flushing and developed neck hives. She was taken to the MSB emergency room, where she was closely monitored. There, she was given dexamethasone 6 mg IM once, diphenhydramine 50 mg orally and famotidine 20 mg orally once. After about 2 hours of observation, he was discharged home on the following: prednisone 40 mg orally daily and diphenhydramine 25 mg q8h PRN.
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| 63 | 2021-01-31 | difficulty speaking | Hoarseness for 3 hrs in the morning. |
| 63 | 2021-01-31 | pain in extremity |
Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contacta...
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Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included Sjogren's Syndrome, connective tissue disorder, high blood pressure, was pre-diabetic, and had a known allergy to penicillin. The patient had other medications in two weeks (unspecified). The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to the vaccination. The patient experienced sore arm at injection site on 13Jan2021 at 21:00. The patient did not receive any treatment for the events. She was not COVID tested post-vaccination. Outcome of the event was recovered.
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| 63 | 2021-01-31 | weakness |
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions...
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The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
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| 63 | 2021-01-31 | tremor, weakness | itching 3-4 days tremors, weakness |
| 63 | 2021-02-01 | tingling |
Pt began complaining of itching and tingling. Made contact with patient and within a few minutes she...
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Pt began complaining of itching and tingling. Made contact with patient and within a few minutes she developed a rash and difficulty breathing
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| 63 | 2021-02-01 | pain in extremity | severe bone pain, arms, back pain, hands, and fingers. |
| 63 | 2021-02-02 | numbness |
Patient complained of numbness on her ring and pinky fingers of left hand. Numbness resolved. Obser...
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Patient complained of numbness on her ring and pinky fingers of left hand. Numbness resolved. Observation done.
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| 63 | 2021-02-03 | pain in extremity, feeling hot |
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,...
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1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
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| 63 | 2021-02-03 | pain in extremity |
Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperatu...
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Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-03 | numbness |
Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactabl...
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Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration, injection in upper left arm, on 20Jan2021 at 10:45 at single dose for COVID-19 immunization; administered in a clinic, like the county clinic. The patient's medical history included ongoing over weight (stated she is 100 pounds over weight), ongoing slight heart disease, ongoing thyroid issue, ongoing blood pressure, and feeling like claustrophobic with the mask. The patient previously received swine flu shot in 1976 and experienced odd headache, and received flu shot two months ago (Nov2020). She mentioned that in 1976 she was in the military and had the Swine Flu Shot. The president made it mandatory they get it because they were afraid there was going to be an attack and they all had to get this vaccine. After getting this vaccine she had an odd headache. She also had a headache after getting the COVID 19 Vaccine, but it was not as bad. She had a little headache with the numbness after she got the COVID 19 Vaccine. While in the military when she got the Swine Flu shot they administered it with an air gun. She does not have any details to provide a lot/exp/NDC. They were just hurrying up to administer because afraid of possible biologic attack. She mentioned a lot of people have had bad reactions to the swine flu shot, but no additional details provided. Concomitant medication included metoprolol and ongoing lisinopril; both for blood pressure. There were no additional vaccines administered on same date of BNT162B2, and there were no prior vaccinations within 4 weeks. The patient experienced numb feeling from head all the way to nose on 20Jan2021 10:46, and headache on 20Jan2021. The patient called to report minor adverse reactions that occurred after getting the vaccine. She did not want her HCP contacted because she wants to ensure she gets the second shot. She clarified the reaction was odd. She had her face mask on when she got the shot. Normally she has the feeling like claustrophobic with the mask on which also occurred after she got the shot. After she got the vaccine, she also started to feel numb from her head all the way to her nose. It lasted 45 minutes. She started to feel this numb feeling 1 minute after getting the vaccine. She could tell something was not right. She thought at first it was the face mask, but after she took the mask off after waiting the 15 minutes under observation, she still had the numb feeling as it had not gone away yet. She could touch her face and could feel the numb feeling. The numb feeling was like getting a tooth filled, not that bad, but something like that. The outcome of the event numb feeling from head all the way to nose was recovered on 20Jan2021 at 11:31, and the outcome of the event headache was unknown. She mentioned she has some friends who have passed away from COVID and who were hospitalized from COVID. That is why she is so grateful for the vaccine and putting it out there.
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| 63 | 2021-02-03 | feeling cold |
delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get...
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delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.
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| 63 | 2021-02-03 | discomfort |
muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a ...
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muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm on 02Jan2021 at a single dose for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.
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| 63 | 2021-02-05 | pain in extremity |
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hour...
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Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
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| 63 | 2021-02-07 | muscle spasms |
Got covid 4 days after vaccine, severe cough, loss of taste, smell, aches, pain especially in my lef...
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Got covid 4 days after vaccine, severe cough, loss of taste, smell, aches, pain especially in my left side of neck. Went to E.R due to muscle spasms, taking motrin, tylenol. Still have severe neck pain.
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| 63 | 2021-02-07 | feeling hot |
My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under...
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My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-02-08 | tingling, night sweats |
Experienced severe cold chills whereas my body felt like pins and needles all over including body ac...
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Experienced severe cold chills whereas my body felt like pins and needles all over including body aches and fatigue. Woke up with night gown damp, so I probably had a low grade fever.
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| 63 | 2021-02-08 | flushing, tingling |
Patient felt flush, lips and face tingling while waiting her 15 minutes. We brought her back to moni...
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Patient felt flush, lips and face tingling while waiting her 15 minutes. We brought her back to monitor vitals. At 5 min post vacine BP 166/87 HR 98 O2 99%, 10 min post vaccine 143/80, 88 and 99%, 30 min post 140/76, 86 and 99%. Pt was then discharged to home feeling "much better"
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| 63 | 2021-02-08 | migraine |
Severe head pain started at about 4 am on 1/29 and progressively got worse. By 7 am it led to nausea...
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Severe head pain started at about 4 am on 1/29 and progressively got worse. By 7 am it led to nausea, vomiting, and incapacitating pain. I would rate this a 10 out of 10 on pain scale. My Dr. was contacted and I was prescribed Zofran for nausea and Imitrex for the migraine about 11 am. The medications eased the symptoms to a manageable level. I have no current history of migraines, and have had two subsequent migraines, but not as severe.
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| 63 | 2021-02-09 | burning sensation |
Got like the burning sensation too; This is a spontaneous report from a contactable consumer. A 63-y...
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Got like the burning sensation too; This is a spontaneous report from a contactable consumer. A 63-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3249) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, menthol, zinc oxide (CALMOSEPTINE [MENTHOL;ZINC OXIDE]), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included hiatus hernia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated, "I just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that I used on it. But I kind of got like the burning sensation too." The outcome of the event was unknown.
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| 63 | 2021-02-09 | muscle spasms | Low grade fever, headache, muscle spasms, fatigue, aches and stiff muscles |
| 63 | 2021-02-09 | feeling cold |
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up...
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Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
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| 63 | 2021-02-09 | burning sensation |
burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blist...
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burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blistering raised rash on right leg, arm, buttcheek and back; Dermatitis; the rash/it is red; This is a spontaneous report from a contactable Consumer (patient). A 63-year-old female patient received bnt162b2 (lot number: EL3249, Expiry Date: May2021), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included Hiatal hernia, heartburn and stuff. The patient's concomitant medications was unspecified medication for heartburn and stuff. The patient previously took clindamycin and allergy. The patient received vaccine on 15Jan2021, started developing severe blistering raised rash on right leg, arm, buttcheek and back on Jan2021. The patient experienced rash, now raised and blistering. On 15Jan2021, legs butt cheeks on back right side of body (same side of body) burning sensation. Patient got a dermatitis on Jan2021. She don't know what dermatitis looks like but the rash she got, it like raised up and it is red and some of it is like blistered. Because she got like a blistering rash at first it was just a rash then it started kind of blistering. They have gotten worsened, they started Monday or Tuesday (Jan2021), the rash started but its got worse since then and spread. She just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that she used on it. But she kind of got like the burning sensation too. Its an ointment. It is like a diaper rash ointment. She figured she would try that because she did an antibiotic ointment (Unspecified Ointment) and it didn't work at all. The outcome of the event burning sensation was unknown, other events was not recovered.
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| 63 | 2021-02-09 | weakness |
left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report...
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left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Elo142), via an unspecified route of administration into the left arm on 14Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included calcium (CALCIUM), vitamin d3 (VITAMIN D3) and monascus purpureus (RED YEAST RICE). On 14Jan2021, patient experienced bad headache, was nauseous, had no energy and was not feeling well. On 15Jan2021, patient also experienced left ear ringing. The patient received no treatment for the events reported. Outcome of events was recovering.
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| 63 | 2021-02-10 | pain in extremity |
The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a t...
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The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.
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| 63 | 2021-02-10 | pain in extremity |
Very sore arm Tightness in high chest, near collarbone only on right side Felt like I needed to co...
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Very sore arm Tightness in high chest, near collarbone only on right side Felt like I needed to cough but couldn?t. No true shortness of breath.
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| 63 | 2021-02-10 | seizure |
my lips were tingling followed by naushia , high blood pressure and heart rate. the ambulance was c...
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my lips were tingling followed by naushia , high blood pressure and heart rate. the ambulance was called i was then transported to hospital. where i had two sezuires. i was given adavan and sent home. with the instructions i was not allowed to have a follow up shot
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| 63 | 2021-02-11 | seizure |
Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema. ...
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Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema. On 2/5 @ 1307 start having seizure activity that lasted for over 20 minutes. Per hospital policy code blue was called. This resulted in an ER send out.
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| 63 | 2021-02-14 | pain in extremity |
Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild...
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Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating. Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling. It was a very unusual feeling of unconscious then conscious delirium feeling.
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| 63 | 2021-02-14 | facial pain, numbness |
strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my f...
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strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face. Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't. after 1 hour the feeling began to fade. and then went away.
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| 63 | 2021-02-15 | feeling jittery |
Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clea...
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Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clearing of throat observed. Bilateral breath sounds were clear and equal. No angioedema noted. Vital sings were monitored. Pulse was 98-99% on room air. Later felt a headache and felt jittery. Benadryl 50 mg PO was administered. Within 20 minutes of Benadryl symptoms improved. Prior to discharge the patient was no longer clearing her throat. Patient states she felt better. Husband reports chest and hive are basically gone. Patient remained alert and oriented x4 the entire visit. Reviewed to continue with over the counter Benadryl and take per directions on bottle. Husband reported he would stop and get Pepcid to take with Benadryl. Patient ambulates out of clinic without problems. 4:28 pm 161/88 89 16 97% 4:36 pm 149/82 79 17 99%. 4:43 pm 142/66 71 17 99%. 5:00 pm 124/ 83 72 15 98%.
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| 63 | 2021-02-15 | pain in extremity, speech disorder, weakness |
Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wanderin...
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Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wandering places she should not. She was in another residents room. She is speaking to staff in another language. VERY confused. Trying to eat her napkin. Unable to dress herself. 2-16-2021 incontinent. not normal for her. unable to stand up. very weak. still very confused. left arm pain. falling asleep mid sentence.
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| 63 | 2021-02-15 | weakness, tingling |
Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the...
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Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep. I tried to called my doctor but their phones are down and I will try reach back out this afternoon.
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| 63 | 2021-02-17 | nerve pain |
I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine...
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I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine. On Jan 6, 2021 I went to the ER for severe abdominal pain, 2 days later broke out with rash and diagnosed with Shingles. I took steroid, Valtrex and Gabapentin. Rash on abd and around to lower back, left side. The rash was not bad but the nerve pain was horrible. 2nd dose was due Jan 22, 2021, I was advised to wait due to still having shingle pain. I was getting better, pain was subsiding so I got my 2nd dose on Feb 5, 2021. I experienced an increase in my shingle pain, from a 2 up to a 5, for about another week. It is still some pain, I am still on Gabapentin and Tylenol to keep the pain at about a constant 1-2 (Feb 18, 2021).
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| 63 | 2021-02-17 | numbness |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
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| 63 | 2021-02-17 | pain in extremity |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK9231, intramuscularly into the left arm on 05Jan2021 at single dose for covid-19 vaccination. Medical history included in Dec2020 around 23Dec2020 she tested positive for Covid-19. There were no concomitant medications. Patient said that because of the time of her retirement, she went to the VA and got the vaccination the first week of Jan2021. She said that with the first vaccination she said that she had chills, fever, and her arm hurt real bad. She said that her symptoms came on during the night. She mentioned she had experienced some side effects which went away after a few days. She had herself tested last 06Jan2021 (also reported as 07Jan2021, pending for clarification) for Covid-19 antibodies which turned out positive and PCR which turned out negative. The outcome of the event "Covid antibodies which turned out positive" was unknown, while outcome of other events was recovered in Jan2021.
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| 63 | 2021-02-18 | tingling, pain in extremity |
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ...
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Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
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| 63 | 2021-02-19 | feeling cold |
24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stom...
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24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stomach, and back One lymph node enlarged under left arm - size of a golf ball, lasted 2 days
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| 63 | 2021-02-21 | numbness |
Sudden numbness, dizziness on and off, numbness receded. Pt encourage to stay but refused and left ...
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Sudden numbness, dizziness on and off, numbness receded. Pt encourage to stay but refused and left facility. Instructed to follow up with PCP. 1520 BP 108/58, HR 76, OSat 98% 1540 BP 110/64, HR 76, OSat 97%
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| 63 | 2021-02-21 | flushing |
nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after secon...
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nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after second immunization (approx. 18 hours post) and lasting approx. 12 hours, some residual abdominal pain and nausea for an additional day
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| 63 | 2021-02-23 | tenderness |
Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous ras...
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Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous rash to L arm and hand with blister present on medial aspect of proximal forearm. Not pruritic, not painful. Area with blister is tender to the touch. Rash is not present on the L shoulder, R arm, or back. Denies fevers. 2nd dose of COVID vaccine to L arm last Thursday. The rash seems to originate from the vaccination site and does not extend upwards. The rash was noticed only today during an office visit. Patient has an intellectual disability, and very independent. always wears a long sleeve and her caregivers had not noticed it until today when rash extended down to her hands below the long sleeve.
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| 63 | 2021-02-24 | pain in extremity, night sweats |
I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to ...
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I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.
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| 63 | 2021-02-24 | feeling cold, pain in extremity |
Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm g...
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Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm got sore, painful to lift or move around. Icy feeling and aching when arm is quiet. Painful to rotate shoulder. Some dizziness and lightheadedness.
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| 63 | 2021-02-25 | tingling, tremor, cold extremities, numbness |
Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in...
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Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
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| 63 | 2021-02-25 | discomfort |
Inflammation on right side of neck throat and back area. Causing choking feeling of right side of n...
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Inflammation on right side of neck throat and back area. Causing choking feeling of right side of neck/ throat for approx. 8-10 hrs. .............Took several days to a gradual subsiding. Pressure felt in back of neck as well.... Same side loud tinnitus in right ear....took a couple days to subside.........during heightened swelling in nick muscles chest/ heartburn. Subsided after a short while.
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| 63 | 2021-02-25 | discomfort |
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Detai...
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Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient stated she was experiencing some \"pressure and swelling under her upper ribcage\" and that she has had this reaction in the past when she accidently inhaled some chemicals. Patient was given one dose of Epinephrine IM into her left thigh and felt relief in pressure after 3 minutes. Patient was advised that if she experiences other symptoms to go to the ER.
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| 63 | 2021-02-25 | burning sensation |
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s...
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anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
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| 63 | 2021-02-25 | pain in extremity |
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar...
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general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
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| 63 | 2021-02-25 | feeling hot |
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf...
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got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
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| 63 | 2021-02-25 | tingling, numbness |
tingling and numbness on left side of mouth and face, beginning immediately after injection, and con...
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tingling and numbness on left side of mouth and face, beginning immediately after injection, and continuing intermittently for two days so far. Exacerbation of rash on right hand that usually occurs when exposed to wheat, beginning 24 hours after injection. Muscular pain in back beginning 12 hours after injection and subsiding 40 hours after injection.
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| 63 | 2021-02-26 | difficulty speaking |
10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no s...
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10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no swelling noted to throat/lips/face. Pt's HR 74, BP 150/90. Ambulance called to scene and pt reporting improvement in symptoms upon ambulance arrival. Report provided to Paramedic, pt transported via ambulance to local hospital.
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| 63 | 2021-02-26 | migraine |
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific....
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Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
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| 63 | 2021-02-28 | weakness |
Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction...
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Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.
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| 63 | 2021-02-28 | numbness |
PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD ...
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PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD SHORTNESS OF BBREATH, CHEST TIGHTNESS, NAUSEA AN VOMITING, FACE NUMBNESS AND TINGLING, AND HIGH BLOOD PRESSURE.
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| 63 | 2021-02-28 | muscle twitching |
Patient experienced twitching in her arm following injection. BP readings 150/110 and 130/100 HR 64 ...
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Patient experienced twitching in her arm following injection. BP readings 150/110 and 130/100 HR 64 95% O2 on RA BGL 90
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| 63 | 2021-02-28 | burning sensation |
Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chi...
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Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chills aches and pains and headache the latter lasted three days
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| 63 | 2021-02-28 | tingling, nerve pain |
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, E...
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Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Dose potentially administered too high but patient didnt bleed. Banaid placement described as one finger width below acrimion bone. Immediately \u2026 at the time of injection \u2026 shooting nerve pain radiating down the arm into fingers. Pain became a hot tingle over the next 15-30 minutes. Impaired right arm mobility and range of motion \u2026 shoulder pain with motion beyond a modest range. Three days later still experiencing some pain with certain arm motions \u2026 primarily raising arm above shoulder
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| 63 | 2021-02-28 | feeling hot |
heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable co...
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heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 26Jan2021 11:00 at a single dose for Covid-19 immunization, and potassium chloride ER, via an unspecified route of administration from an unspecified date at 10 mg, daily (every day) for low potassium. Medical history included anxiety and was afraid to take her anxiety medicine; hypertension, and iron deficiency; all from an unknown date. Concomitant medications included amlodipine besilate (NORVASC) for hypertension, and colecalciferol (VITAMIN D [COLECALCIFEROL]). It was reported that when the patient got the shot it did not hurt but when she sat down for about a minute (26Jan2021), her heart start palpitating, and racing and then she got kind of warm and then it went away. She didn't pass out, had no shortness of breath. She just wanted to know if it was one of the side effects and that's why she need to report this. The patient was looking at the ingredients that Pfizer have like potassium and stuff. The patient takes potassium every day. She added that maybe she should have not taken her potassium at the same day, would make your heart raise that's why she was wondering. Otherwise the patient felt fine. She just needed to report this. Furthermore, patient stated that maybe because she was nervous, she was scared to take certain anxiety medicines (unspecified medications) she did not know would had it though. The outcome of the events was recovered.
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| 63 | 2021-02-28 | pain in extremity |
sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a ...
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sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular in left arm near shoulder on 25Jan2021 10:20 at a single dose for COVID-19 immunization/prevent covid. Medical history included ongoing arthritis diagnosed years ago, ongoing arthralgia, has two titanium knees and she had the hip pain prior to the COVID injection but now her hip pain is radiating down to her leg. Concomitant medications included celecoxib (CELEBREX) from an unknown date and ongoing at 100mg capsule once a day by mouth for arthritis. The patient previously received the first dose of BNT162B2 (Lot: EK9231) administered on 05Jan2021 around 13:00, intramuscular injection in left arm near shoulder for COVID-19 immunization, SHINGRIX two shot dose, she had one in Dec2018 and the second one in Mar2019, stated that it hurt to where she could not even lift the arm. It was reported that on 25Jan2021, patient had the second dose of the vaccine and she had the typical sore arm 6 hours later that lasted 24 hours. She clarifies it recovered completely 48 hours later and she does not have the soreness as of today, states it does not bother her. Reports she also has it to where her knees and hip are hurting her. She has two titanium knees and she had the hip pain prior to the covid injection, but now her hip pain is radiating down to her leg. She has arthritis and with weather changes she experiences the hip pain. Her daughter told her it is a side effect of the shot. She is asking why this hip pain is radiating down. The knee and hip pain started around 9pm on 25Jan2021. Reports it is a tad better but it is painful. She does not have a fever. Treatment for the events knee pain included putting ice and heat on her knee and hip. The outcome of sore left arm/hip pain is radiating down to her leg was recovered on 27Jan2021, knee pain was recovering.
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| 63 | 2021-02-28 | tingling |
tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report fro...
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tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
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| 63 | 2021-03-01 | tingling |
Sharp deep pain in the center of chest, feeling of constriction around chest; pain and tingling in b...
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Sharp deep pain in the center of chest, feeling of constriction around chest; pain and tingling in both feet
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| 63 | 2021-03-01 | weakness |
This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled u...
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This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled up & sore difficult to swallow. Extreme long lasting exhaustion. Body is weak & sore muscles & joints. I have not been ok since my 2nd shot. I had a hard marble lymph node in my neck after the 2nd shot too.
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| 63 | 2021-03-02 | flushing |
2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am hea...
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2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am heart rate 108, no temp scratchy throat 10am diarrhea ; unease and rapid heart rate continue 5pm read about adverse events, called doctor, took Benadryl and began to feel better. 3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd
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| 63 | 2021-03-02 | pain in extremity | Bruising and pain at palm up to mid-arm. Swollen arm. 24 hours Fever and chills. 4 hours |
| 63 | 2021-03-02 | difficulty speaking, muscle spasms |
COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot ...
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COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot nausea Day four of shot back and joint pain Day five of shot sick feeling aching all over. Muscle and joint pain and fatigue. Chest pressure, cough, Hoarse voice Day six of shot headache fatigue pain through right eye. 2/5Temp 96.6, 98.6, 1:00pm SPO% 93% Resting heart rate 90 6:30pm SPO% 89%-91% Resting heart rate 102 Tylenol 100 mg 9:00am, 3:30pm TEMP 4:30pm 99.7* Symptoms of the freezing chest and cough as well as headache and feeling poorly kept rising several times a week. Covid 3/1/21 Covid symptoms return just like after Covid 19 1st vaccine. Body aches, joint pain, Chest pain, muscle aches, frozen feeling in lungs, cough, abdominal pain,eye ache, headache and fever. Temp 95.5 SPO 89% - 94% Resting heart rate 92 - 95 (After Covid shot 89%SPO, RHR 105, temp 99.7) 12:25pm temp 99 2/2/21 Feeling a little better. Still fatigue and ill feelings. At nighttime cough comes back with freezing lung feeling. Also started and body aches and joint stiffness. Went to bed took ibuprofen. 2/3/21 Still feeling ill . Woke with productive cough a little looser. Headache fatigue just feeling crummy.
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| 63 | 2021-03-02 | feeling hot |
Complaint of dizziness and feeling warm. Alert and oriented x 4. Respirations even, skin within norm...
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Complaint of dizziness and feeling warm. Alert and oriented x 4. Respirations even, skin within normal limits. Denies shortness of breath, chest pain and palpitations. BP 122/60, P 84, O2 94%, R 16. Patient states that she was feeling dizzy before she came in to clinic and that she had not eaten anything. BP 124/64, P 84, O2 95%, R 16. Patient discharged from clinic.
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| 63 | 2021-03-02 | pain in extremity, discomfort |
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at...
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Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
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| 63 | 2021-03-02 | facial paralysis |
Was notified by nurse at clinic that Patient started having right eye dripping, swelling and burni...
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Was notified by nurse at clinic that Patient started having right eye dripping, swelling and burning starting on Monday 3/1/21. Patient went to see her Family Dr. with complaint of right side drooping starting today 3/3/2021. She was sent to the ED at Hospital for evaluation.
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| 63 | 2021-03-03 | pain in extremity |
2 lumps on the collarbone, in the front. She guesses, they were lymph nodes; arm hurting; This is a ...
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2 lumps on the collarbone, in the front. She guesses, they were lymph nodes; arm hurting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982), via an unspecified route of administration on 29Jan2021 (1:00-1:30pm) at single dose on the upper left arm (arm left) for COVID-19 immunisation (reported as "age 63, diabetes, is lucky to get being a part-time educator"). Vaccination facility type was school. Vaccine was not administered at military facility. Medical history included ongoing diabetes.The patient's concomitant medications were not reported. No other vaccines given the same day or 4 weeks prior. On 29Jan2021 (Friday), patient got her first COVID shot. On 01Feb2021, patient noticed she has 2 lumps on the collarbone, in the front. She guesses, they were lymph nodes. Patient called her doctor's office and was told to call Pfizer to ask for guidance. No other vaccines given the same day or 4 weeks prior. Patient had the usual arm hurting. In the past, she had the Shingles vaccine, felt kind of achy and a little tiredness, but never had this happen before (also reported as "AE(s) following prior vaccinations: arm hurt, kind of achy and a little tiredness). Patient was going to wait to see if they go away, hoping they would go away and then if not she would make an appointment. Patient has diabetes and takes medication for that, but does not provide any further details. She wanted to know if this is something others have experienced or if this side effect has been reported or to possibly be expected. The events did not require emergency room and physician office visit. There were no family medical history relevant to events and relevant tests. Outcome of the events was not recovered (reported as ongoing).
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| 63 | 2021-03-03 | pain in extremity, tingling, numbness |
It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I sta...
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It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I started having a lot of pain in my legs (calves and feet) at first it was extreme pain that led to tingly prickly sensations. I went home, went to bed, was up all night in bed groaning because of the pain, and when I tried to stand, was unable to. I crawled to my phone and called my sister (who lives next door) who ran over. She has a wheelchair and took me to the hospital. I was unable to walk alone for four days and the pain was not as extreme after 5 days. I am now 3 weeks out and still have numbness in my legs.
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| 63 | 2021-03-03 | pain in extremity, pain in extremity |
Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to ex...
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Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to experience acute upper arm/ clavicular joint pain and bilateral hands were "cupped". Received steroid treatment from PMD.
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| 63 | 2021-03-03 | tingling |
Pe state her left corner of her mouth is "tinging" pt states the same thing happened with first dose...
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Pe state her left corner of her mouth is "tinging" pt states the same thing happened with first dose vaccine but this time "was worse". Pt refused Benadryl at first. Pt denied shortness of breath. Vitals at time of report 136/83. 1700 vitals 142/73. 1702 pt took Benadryl 25mg PO. at 1710 137/77 pt declined any further treatment and was released ambulator
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| 63 | 2021-03-03 | burning sensation |
Skin around the eye area feels like it us burning. No outward signs or rash, no swelling. Just burni...
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Skin around the eye area feels like it us burning. No outward signs or rash, no swelling. Just burning feeling and face feels like it's cracking when blinking or squinting. No fever or rash.
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| 63 | 2021-03-04 | pain in extremity |
Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as w...
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Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as well as my cheeks. Then my lower lip began to swell. I would consider these symptoms somewhere between mild to moderate. The symptoms began around 4:30 in the afternoon and subsided as the evening progressed. The next morning (today), my face feels basically normal again. My only symptoms now are a sore arm and a slight headache. I have experienced allergic reactions before but never from a vaccine.
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| 63 | 2021-03-05 | feeling hot |
No issues during 15 minute observation period after receiving the vaccine. So I left the facility to...
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No issues during 15 minute observation period after receiving the vaccine. So I left the facility to go to my car. Then about 15 minutes later my face started to get really hot with slight swelling. Then after several more minutes throat became tight and started to experience extreme difficulty swallowing. I was still in the parking lot so I immediately went back inside to the vaccination area asking for help. I did not experience any breathing difficulties during the entire time but did experience extreme difficulty with swallowing and throat tightening. The staff did the usual checks. I was not too awarre of all the things they did but I was given a benedryl tablet which I was able to swallow thankfully. I was told my vitals were very high. Not sure of exact times but sometime shortly after the benedryl things started to fell better. The throat/swallowing started to get better. Face burning started to cool. Stayed in this area for about 20 or 30 more minutes and then told I could go with a comment that I should see my doctor about my high blood pressure. Which I explained I do not have high blood pressure and when checked later in the day it was back to my usual 115 - 125 range . I was concerned about getting the second shot later and was told to take a benedryl either just before I get the next shot or right after.?????? After checking the online cdc guidelines that does not jive at all.
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| 63 | 2021-03-06 | flushing | Pressure in chest, trouble breathing, facial flushing |
| 63 | 2021-03-07 | pain in extremity |
2:40PM 'TONGUE FEELS NUMB AND LIGHTHEADED'. DENIES ANY SOB, DYSPNEA OR DIFFICULTY SWALLOWING. STATE...
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2:40PM 'TONGUE FEELS NUMB AND LIGHTHEADED'. DENIES ANY SOB, DYSPNEA OR DIFFICULTY SWALLOWING. STATES SHE CAN'T TAKE BENADRYL. SPEECH CLEAR, A/O, NO CYANOSIS, W/D, RESP REG WITH EASE. NO ACUTE DISTRESS. SIPS OF WATER AND COMFORT GIVEN. 3PM 'FEELS BETTER NOW'. 3-5-21 3:30PM 'FEELS BETTER TODAY - LEGS ACHE SOME'.
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| 63 | 2021-03-07 | pain in extremity |
Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles ...
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Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles all lasting to 30 hours after vaccine. Itchy Rash on arm and hard sport for 4 days.
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| 63 | 2021-03-07 | migraine | Headache that progressed to Migrane with severe Vertigo that lasted 48 hours. |
| 63 | 2021-03-07 | flushing, feeling hot |
Hot, flushed face and ?stuffy? nose within 20 minutes of vaccine. Abated within two hours. Extreme ...
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Hot, flushed face and ?stuffy? nose within 20 minutes of vaccine. Abated within two hours. Extreme fatigue within 7 hours of vaccine. Woke up next day with burst blood vessels in R eye.
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| 63 | 2021-03-07 | seizure |
Patient finished observation, then suffered a seizure and fall on the way out of the clinic. Paramed...
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Patient finished observation, then suffered a seizure and fall on the way out of the clinic. Paramedics were called and the patient was monitored and transferred to the hospital on site
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| 63 | 2021-03-07 | pain in extremity, weakness, numbness |
Symptoms. Extreme leg and leg pain. Unable to stand for any length of time. Unable to feel my feet...
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Symptoms. Extreme leg and leg pain. Unable to stand for any length of time. Unable to feel my feet. My left knee froze up . Weak wobbly legs. Bleeding gums. Back pain radiating up to my neck. My Neuropathy was pretty much in control until I took the vaccine. I am back in a wheelchair .
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| 63 | 2021-03-07 | flushing |
The vaccine is the only variable that could have caused this reaction. Started mid-morning with a d...
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The vaccine is the only variable that could have caused this reaction. Started mid-morning with a deep flushing in my face, and then spread to arms(bright red elbows) and chest and upper thighs. Raised bumps but not large lesions, very itchy. Onset was this morning, so I do not know how long this may last. Ongoing two hours later. No other reactions.
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| 63 | 2021-03-07 | migraine |
classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-prese...
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classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-present nausea 03/05-present L foot & ankle swelling 03/06-present
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| 63 | 2021-03-08 | feeling hot, flushing, pain in extremity |
1st Day after vaccine - arm soreness, sluggish feeling 2nd Day after vaccine - flushed/warm feeling ...
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1st Day after vaccine - arm soreness, sluggish feeling 2nd Day after vaccine - flushed/warm feeling in face
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| 63 | 2021-03-08 | tenderness |
About two hours after my injection, the muscles in my upper left arm were very sore. It felt like a ...
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About two hours after my injection, the muscles in my upper left arm were very sore. It felt like a bruise, tender to the touch.
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| 63 | 2021-03-08 | weakness, tenderness |
As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did t...
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As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did that in order to sleep better. I did have a lot of stool prior to bedtime, but didn?t think much of it, as I had a lot of water, and thought it might be due to nerves and eating a larger dinner than typical. I went to work, had lunch, and shortly after had explosive diarrhea. I went to clock out, felt weak, and had another episode. I took immodium so I could drive home, had 2 more bouts, took one more immodium, and have not had more. I do feel tender, but am not running a fever. I presume this is not related to the vaccine, but was advised to let you know.
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| 63 | 2021-03-08 | pain in extremity |
I had a sore arm the next day. I had a lot of health issues but not sure they are related to the vac...
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I had a sore arm the next day. I had a lot of health issues but not sure they are related to the vaccine.
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| 63 | 2021-03-08 | slurring |
Patient reports having slurred speech beginning 2000 the evening following vaccination. She presente...
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Patient reports having slurred speech beginning 2000 the evening following vaccination. She presented to the ER on 02/11/2021 and admitted to hospital for Acute CVA. Discharged on 02/14/2021. Patient's PCP recommended completion of series.
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| 63 | 2021-03-09 | feeling hot |
Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and b...
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Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and body felt hot General tired and achy lasting 4 days
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| 63 | 2021-03-09 | flushing |
Pt mentioned some flushing and slightly scratchy throat. Previous history of anaphylactic rxn to all...
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Pt mentioned some flushing and slightly scratchy throat. Previous history of anaphylactic rxn to allergy shots
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| 63 | 2021-03-10 | difficulty speaking, throat numbness |
(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Bena...
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(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Benadryl 25 mg with relief). Prior to second dose, took Benadryl 25 mg at 310pm.... at 350pm, received second dose of Pfizer vaccine.... tingling of lips and tongue within 10 minutes, took Benadryl 25 mg at 4pm...?. progression of tingling of tongue to some numbness of tongue, towards back of throat, some difficulty swallowing, throat hoarseness, chest discomfort, sporatic spot itching of eyeballs - shoulder-forehead-top of right arm. Went to Emergency room around 5pm.... given corticosteroid and Pepcid IV... with relief. Left Emergency room around 730 with minimal tingling of tongue....no other symptoms. Took Benadryl 25 mg by mouth before bed. 3/6/21- woke up with no symptoms.
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| 63 | 2021-03-10 | tingling |
10 hours after first dose of Pfizer Vaccination, I developed an itchy, raised bump that looked like ...
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10 hours after first dose of Pfizer Vaccination, I developed an itchy, raised bump that looked like a mosquito bite on the inside of my left elbow (same arm as vaccination). It resolved over the following couple of hours. 24 hours after vaccination (14 hours after the original presentation of the itchy bump on my elbow), I developed a couple of itchy bumps on my leg and trunk. Over the following 16 hours (24-40 hours after vaccination) I had what was diagnosed by health care professionals as an outbreak of hives affecting both forearms, both ankles, left knee and trunk. This episode resolved about 40 hours after vaccination. One week later, I have had mild, generalized, off and on itching and prickly skin sensation but no obvious outward signs of bumps or rash. I am seeking advice from an allergist on whether to proceed with second vaccination. Will be tested for PEG reaction before then. This is my second report. I requested a key to update my initial report (VAERS E-Report) but never received one.
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| 63 | 2021-03-10 | flushing |
Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO...
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Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO.
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| 63 | 2021-03-10 | pain in extremity |
HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at...
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HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30 minutes at 14 hours post dose - no treatment, self-resolved
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| 63 | 2021-03-10 | tingling | Heavy tongue, pain at injection site, tingling bilaterally in arms. Cleared by EMS |
| 63 | 2021-03-10 | feeling jittery | Jittery, elevated HR, cleared by EMS |
| 63 | 2021-03-10 | pain in extremity |
Pfizer was administered as 1st dose Moderna was administered as the 2nd dose Reported no symptoms ...
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Pfizer was administered as 1st dose Moderna was administered as the 2nd dose Reported no symptoms except sore arm
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| 63 | 2021-03-10 | numbness, pain in extremity |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced c...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.
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| 63 | 2021-03-10 | pain in extremity | headache, fatigue, arm pain, body aches |
| 63 | 2021-03-10 | feeling hot, pain in extremity |
pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness...
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pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness under eyes, checks, and inside her mouth. She had some pinching feelings in her chest which she said this may be acid reflux. Her right leg was hurting near her ankle and foot. Nurse at vax site checked her stats and everything was normal. She was given Benadryl. These symptoms subsided. After getting home she had some tickling in her throat. Pt only has soreness and redness in her left arm today.
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| 63 | 2021-03-10 | pain in extremity |
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; S...
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pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.
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| 63 | 2021-03-11 | difficulty speaking |
11:18 am-Patient stated she felt as though throat was swelling. Clearing throat often- she said more...
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11:18 am-Patient stated she felt as though throat was swelling. Clearing throat often- she said more often than usual. Voice slightly hoarse sounding. Patient states it is more hoarse sounding than usual and husband agreed. Vital signs: B/P 150/90, pulse 75, pulse ox 98%, lung sounds bilaterally, slightly coarse sounding (pt has lung cancer), No wheezing noted, No stridor noted. 11:29 am- 25 mg Benadryl given. Monitored patient. 11:41 Vital signs B/P 154/86, Pulse 75, pulse ox 98%. No changes in lungs sounds with auscultation. 12:08pm - Advised client to proceed to ER due to current lung cancer treatment and recent prednisone. Client refused ambulance. 12:13- Patient left for hospital ER, with husband driving.
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| 63 | 2021-03-11 | pain in extremity, hot flush, tingling |
Immediate pain from injected arm, across back up the neck, causing headache and going across to ot...
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Immediate pain from injected arm, across back up the neck, causing headache and going across to other arm, down arm and making left hand tingle. Sensitivity to use of finger on left hand. That went away next day. Residual effects pain in my jaw and teeth sensitivity, continues to date. Hot flashes, shooting pains in foot, arm, hand, eye, leg randomly. raised blood pressure.
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| 63 | 2021-03-12 | flushing |
Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very sever...
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Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very severe dizziness and lightheaded.
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| 63 | 2021-03-12 | pain in extremity |
Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at ...
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Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at 11 pm 3/12 and Soothsayer herbal tea at 7 am 3/13. Very tired both shoulders hurt noon 3/13. Took an hour and a half nap from 1-2:30 pm 3/13. Still tired
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| 63 | 2021-03-13 | weakness | Bruised injection site and very sore for 2 days; fatigue; headache; body aches; very weak |
| 63 | 2021-03-13 | cold sweat | epigastric pain, nausea, clammy, chills Hospitalized inpatient Hospital |
| 63 | 2021-03-14 | tingling, burning sensation |
1st Vaccination on 3/4; Symptoms began 3/11 - itchy rash on upper back and left underarm; underarm r...
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1st Vaccination on 3/4; Symptoms began 3/11 - itchy rash on upper back and left underarm; underarm rash became tingley and burning; rash has spread to the rest of my left arm and onto my right arm; very little itching on arms, more on back; only left underarm tingles and burns
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| 63 | 2021-03-14 | feeling cold, pain in extremity |
Beginning at approximately 9pm on 03/13/2021, my upper arm became very sore and nausea started. By...
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Beginning at approximately 9pm on 03/13/2021, my upper arm became very sore and nausea started. By 7am on 03/14, I was extremely chilled and still nauseated, however my arm soreness was subsiding. I fell back to sleep and woke up about 2pm. I had finally warmed up but still slightly nauseated. By 6pm, I ate some dinner and today, 3/15, I feel normal.
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| 63 | 2021-03-14 | pain in extremity |
Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Bo...
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Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.
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| 63 | 2021-03-14 | burning sensation |
Patient called the pharmacy on 03/15/2021 to report adverse effects experienced post-vaccination. Pa...
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Patient called the pharmacy on 03/15/2021 to report adverse effects experienced post-vaccination. Patient reported feeling a burning sensation in front of / underneath knee cap area of right leg with symptom onset of about 3-5 days post-vaccination. Patient noted that symptoms escalated to severe swelling of both knees about a week post-vaccination.
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| 63 | 2021-03-14 | flushing |
Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fin...
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Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fine and left. She returned to the clinic an hour (or so later) reporting feeling flushed and "off". We had patient sit back down and began observing again. Patient developed a cough which became progressively worse. We monitored her O2 sat, pulse and BP. At 3:30pm Patient received epinephrine 0.5mg IM and Diphenhydramine 50mg IM. EMS was called. Patient's cough subsided. She refused transport to the hospital AMA. Patient left the clinic on her own, accompanied by her husband. ;"
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| 63 | 2021-03-14 | feeling hot |
So-called "Covid Arm" - itchy, hard, warm, red area appeared on Day 7 after vaccination. It was stil...
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So-called "Covid Arm" - itchy, hard, warm, red area appeared on Day 7 after vaccination. It was still present 2 days later (currently)
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| 63 | 2021-03-14 | migraine |
Vaccine triggered migraine. Relief from sumatriptan and motrin. Continued to come back for 2 more da...
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Vaccine triggered migraine. Relief from sumatriptan and motrin. Continued to come back for 2 more days but was relieved by motrin. Also stiffness in shoulder and neck on opposite side of body that was damaged years ago in car accident causing whiplash. That is still ongoing 11 days later, but seems to be resolving slowly.
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| 63 | 2021-03-14 | feeling cold |
drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of n...
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drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing. Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure. The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021. The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 63 | 2021-03-15 | seizure |
Pt received vaccine at 15:25. At 15:33 pt. reported her lips felt tingly. At 15:38 patient began s...
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Pt received vaccine at 15:25. At 15:33 pt. reported her lips felt tingly. At 15:38 patient began seizing and was lowered to the ground by 2 staff members. Oxygen was placed on patient at 5L via nonrebreather mask. Initial BP 160/80 manually on right arm, Heart rate 26, oxygen saturation 84%. Oxygen increased to 10L and EPI 0.5 mg administered IM into right anterolateral by, APN at 15:43. 15:44 vitals: BP 182/90 manual R arm, 110 heart rate, 99% 02. Oxygen decreased to 8L. Seizure ended at 15:45. Vitals at 15:45 180/105 BP, 115 heart rate, 98% O2.Vitals at 15:48 185/100, HR 102, oxygen 99%. EMS arrived at 15:50 & 2nd seizure began at 15:50. 15:50 vitals BP 245/110, 131 HR, 99% O2. 15:52 vitals 240/110 BP, 107 HR, 99% 02. Pt. left via ambulance at 15:55.
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| 63 | 2021-03-15 | weakness, pain in extremity |
Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became ...
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Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became very ill around 1pm with incontrollable chills, severe spinal pain from Cervical to sacrum, and severe radiating pain on both sides of my back. Pain ranked as a 7-8/10. Took 800 mg of Advil and then took Tylenol 3 hours later and no change. Thought about going to ER but did not go. The next day pain was reduced to a 3/10 and was extremely tired and no energy and was lying down most of the day with extremely fatigue. Gradually better the next two days for full recovery.
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| 63 | 2021-03-15 | tenderness |
The following day after the 2nd vaccine, I felt a small itching on the left side of my neck/shoulder...
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The following day after the 2nd vaccine, I felt a small itching on the left side of my neck/shoulder blade. I didn't scratch but I felt swelling. After softly rubbing my neck, I felt a little bubble as if there was liquid in the bubble area. I thought maybe it was a side effect so I waited a full week. Along with the itching & swelling, there was a small amount of tender pain. The swelling still persists. On the 10th day after the vaccination (March 15th), I saw my doctor. He felt the same area sensation of a bubble around my shoulder blade. So far, there has been no treatment.
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| 63 | 2021-03-15 | difficulty speaking, inability to speak | Throat hoarseness severe unable to speak and beginning of closure, hives. |
| 63 | 2021-03-16 | throat numbness |
14:40 Started reaction throat and tongue numbness, I drank 2 glasses of water. 15:00 lost my voice, ...
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14:40 Started reaction throat and tongue numbness, I drank 2 glasses of water. 15:00 lost my voice, my eyes puffed up a bit and my face was not well, lungs wheezing, Epi administrated by PA vaccination clinic. 15:32 UC for observation. Administered Decadron 10 MG injection. Blood Pressure 150 /80- HR 88.
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| 63 | 2021-03-16 | burning sensation, feeling hot |
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hi...
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I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
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| 63 | 2021-03-16 | weakness |
patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad...
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patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad that evening , had 1 emesis episode and felt "crummy" with fatigue/weakness/sweats/malaise for 3 subsequent days without recorded fever, rash , change in color of urine but decreased oral intake and began to feel better 3/14 Sun, she then awoke with Heart racing and presented to our ER 0300 3/15 with A fib with RVR which resolved after approx 30 min while receiving IV fluids in ER without other treatment. She was treated and released to followup here today 3/17/21 at our office. I noticed on routine ER labs that she had elevated transaminases (ALT/AST) in 300 unit range (normal up to 40-50) which she has never had on previous panels with normal bili, alk phos , and otherwise normal CMP. At the time of followup her EKG was normal and she has had no further symptoms but transaminases are redrawn and she is advised not to get her second Covid shot. Patient is elderly CHADS VASC score is 1, nonsmoker , family hx of heart disease.
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| 63 | 2021-03-17 | migraine |
I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that...
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I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that night but I couldn't hardly slee because of the pain. I had to call out because I could hardly walk. Steroid dose was for 9 days and after wards it resolved.
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| 63 | 2021-03-17 | numbness | Numbness of forehead, jaw and tongue. |
| 63 | 2021-03-17 | flushing | Red burning ears ..came on in a rush/flush like way |
| 63 | 2021-03-17 | pain in extremity, weakness |
Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, ...
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Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak, slight headache and nausea. Tired and weak, achy and slight headache when woke up on 3/18. Still somewhat painful to take a deep breath and injection arm painful. Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18
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| 63 | 2021-03-17 | weakness |
Tues. March 16 10:20 am - Received shot. Tues. March 16 11:00 pm - Started feeling tired, achy, a...
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Tues. March 16 10:20 am - Received shot. Tues. March 16 11:00 pm - Started feeling tired, achy, and started having chills. Went to bed. Felt like I had fever, but did not take temp. Wed March 17 Throughout early morning - same symptoms except no chills anymore. Fever varied from 99.5 - 100. Wed. March 17 - Throughout day and evening - Too weak to function, fever in morning, not in afternoon, when getting up weak and had to go back to bed. Thursday, March 18 3:00 -3:30 am Running fever 99.5 - 100.1 with mostly just headache. Thursday, March 18 7:00 am Woke up with sweat and temp. was gone.
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| 63 | 2021-03-17 | facial paralysis |
Twenty seven days after my second vaccination I developed Right side of face paralysis and went to E...
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Twenty seven days after my second vaccination I developed Right side of face paralysis and went to ER. After steroids and valcyclovir I was 100 percent recovered.
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| 63 | 2021-03-17 | tingling | tingling around mouth; resolved |
| 63 | 2021-03-18 | feeling hot | Feels super warm and abnormal. Felt better after sitting or 5 minutes without any interventions |
| 63 | 2021-03-18 | tingling, feeling cold |
Guest received first dose of Pfizer Vaccine. While in the Observation Area she reported - Metallic ...
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Guest received first dose of Pfizer Vaccine. While in the Observation Area she reported - Metallic Taste, Left arm tingling, cold feeling, and light ? headedness.? Vital signs assessed. Discussed symptoms and guest reported improvement within two to three minutes. VS: B/P: 150/72, P ? 71, SPO2 ? 100% R/A. Interventions: Water, snack, observed for 30 minutes. Guest reports no further symptoms upon departure.
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| 63 | 2021-03-18 | bell's palsy, facial paralysis |
I was vaccinated on Friday morning. Everything seemed OK. On the next day Saturday, I felt some numb...
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I was vaccinated on Friday morning. Everything seemed OK. On the next day Saturday, I felt some numbness on me left upper lip and right tooth. The numbness increased and changed to my left face paralysis. I could not chew or close my left eye totally. My husband brought me to the ER on Tuesday morning. They diagnosed that I had peripheral Bell's palsy and gave prescription to me with antivirus medicine, prednison, eye oilment and eye drops, and shield to cover my left eye while I go to sleep. Today is Friday, one week after I got vaccinated. I also go to get acupuncture.
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| 63 | 2021-03-18 | pain in extremity, burning sensation |
Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morni...
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Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morning started to feel terrible - sore arm, headache, severe body aches, fever, chills, nausea. Continued through to Thursday. Pt started to feel intermittent SOB, difficulty with getting in air. This subsided after some time. NO rash, hives, tight airway, vomiting. Patient reports today feels a little better but entire body still has burning sensation. Going to Urgent care for evaluation.
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| 63 | 2021-03-18 | tingling |
Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feel...
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Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feeling all over. She was moved via wheelchair to an observation area. Initial vitals at 1245 98% on room air, 100 HR, BP 157/94. Pt stated she was feeling better and was then escorted at 1330 to the bathroom via wheelchair. Upon her return, she reported now experiencing chills and was shaky. Vitals at 1340 were 176/86, 96%, and HR 99. Pt denied SOB, fullness in mouth, and itchiness. Further vitals: 1357 175/85, 96%, HR94. 1405 183/105, HR 107, 97%.; 1406 173/80, HR 104, 97%. It was determined by RN that 911 would should be called to further evaluate the patient. Patient was taken via EMS to the hospital with her husband in attendance.
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| 63 | 2021-03-18 | weakness, tremor |
Pt started having new onset of left hand swelling of medial pal, and forearm. PT also had weakness, ...
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Pt started having new onset of left hand swelling of medial pal, and forearm. PT also had weakness, tremors and high blood pressure (159/98). Pt blood sugar was in the 330s; decrease cap refill. Pt states she did not ear or drink much this morning. EMS assist was called. Pt was transferred to Emergency Room
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| 63 | 2021-03-18 | tingling, feeling cold, tremor |
She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her who...
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She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her whole body from her head to her toes. They called a doctor to stand by her, and spoke with her, and she was explaining what she had with reactions had a very warm sensation through her body. They have a medic station at the event center, and started taking her VS which her BP was high, and kept an eye on her, and kept talking to her. She still had the tingling feeling through her. She had this similar sensation from bee stings in the past. She then got very cold and started shaking all over and her went to 175/101. At that point she had probably been there for about 2 hours and she was then taken to Hospital. She was monitored at the hospital for her BP and did oxygen levels which were fine, and her heart rate was elevated, but then dropped down to 98-99. She asked for something to drink and something to eat, and they gave that to her, and was only at the hospital for about an hour. They told her that she was okay, and they did not give her any medications as the reaction had passed and her BP was down to 149/87, pulse rate 102, and her respiratory rate was good and they dismissed her. She did have fatigue since coming home from the hospital but is otherwise okay. She is scheduled to see her PCP on Monday, 3/22/21.
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| 63 | 2021-03-18 | pain in extremity |
Sore arm, severe headache, 101.2 fever, chills, body aches i have had 3 vaccinations at a time, all...
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Sore arm, severe headache, 101.2 fever, chills, body aches i have had 3 vaccinations at a time, all in the same arm and NEVER gotten sick at all.
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| 63 | 2021-03-18 | pain in extremity |
Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus sym...
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Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus symptoms, headaches- continue to have sinus symptoms- "congestion, headaches, nasal drainage daily with bleeding" Not sure if related to the Pfizer vaccine- just have had continuation of sinus symptoms post 2nd vaccine. Nasal bleeding miner however, frequently throughout day when blowing nose- have been using OTC saline gel or spray-
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| 63 | 2021-03-18 | pain in extremity |
first shot i woke up 7 days later to rash and itchy at site and very Hard...this SECOND shot i got i...
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first shot i woke up 7 days later to rash and itchy at site and very Hard...this SECOND shot i got i woke up next day with swollen arm and pain..took benedryl and icepack..will watch it and tell my family doctor. thank you...i did NOT get sick..
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| 63 | 2021-03-19 | pain in extremity |
Chills started 11pm day of shot.. Headache started shortly after. Aches pains especially in legs , f...
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Chills started 11pm day of shot.. Headache started shortly after. Aches pains especially in legs , fever, and sore injection area.
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| 63 | 2021-03-19 | difficulty speaking |
coarseness, SOB, Itchy throat, swelling to the tongue, normal Vital signs and alert and oriented, hx...
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coarseness, SOB, Itchy throat, swelling to the tongue, normal Vital signs and alert and oriented, hx of anaphylactic reactions given epi, Benadryl and famotidine
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| 63 | 2021-03-20 | tremor, weakness | Disregard, hives, extreme weakness, chills and shaking |
| 63 | 2021-03-20 | feeling jittery |
Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vit...
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Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vitals taking, pt reassured, symptoms resolved within minutes
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| 63 | 2021-03-20 | pain in extremity |
Slight pain in left forearm and hand. Hand felt like I had squeezed a ball a thousand times in a row...
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Slight pain in left forearm and hand. Hand felt like I had squeezed a ball a thousand times in a row. Feeling lasted apx 15 minutes. No pain since.
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| 63 | 2021-03-21 | flushing |
20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER ...
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20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER AND TIGHTING OF MY CHEST. I TOOK ORAL BENEDRYL 10 MINUTES AFTER THE SHOT BUT UNFORTUNETLY IT DID NOT HELP. I WAS GIVE IV BENEDRYL IMMEDIATELY AFTER THAT AND WAS MONITORED FOR 4 HOURS AT THE HOSPITAL. ALSO GIVEN TYLENOL FOR A HEADHACHE DURING MY HSPTALIZATION. IT TOOK APPROX. 30 MINUTES FOR THE SYMPTOMS TO SUBSIDE. I WAS RELEASED 4 HOURS LATER.
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| 63 | 2021-03-21 | pain in extremity |
Started with a bad headache and very sore arm the first night. The morning of the day after I was va...
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Started with a bad headache and very sore arm the first night. The morning of the day after I was vaccinated, I took my temperature and it was up to 101, which is high for me. I ached everywhere and my neck was so stiff, I could hardly stand to turn my head. My left arm, where I was vaccinated felt sore and tight in my shirt, but I couldn?t turn my head far enough to look at it to see if it was red or not. My temp went up to 102, the highest it?s been since I had osteomyelitis after my accident- no kidding! I slept most of the day both Thursday and Friday. I woke up Saturday at 2 pm and felt fine again- like nothing happened. But, I thought it was Friday. I was sick enough & sleeping enough that I acted lost a day completely! I never got nauseous- just terrible headache, stiff neck, joint & muscle pain , fatigue and 102 fever. There is a question of whether I have had Covid. I was very sick for 4 weeks- the whole month of February, 2020. My daughter had been in (Country) on business and met with collegues from all over the (Country), including (Country), in January, 2020. My brother died unexpectedly while she was gone. She flew back to (State) on a Thursday night and then got right back on a flight to (city) to stay with me for a week. She missed the wake, but was a comfort to me. I get very sick about a week after she left.
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| 63 | 2021-03-21 | muscle spasms | c/o of left arm cramping and dizziness. required a wheelchair. no meds for intervention needed. |
| 63 | 2021-03-22 | numbness, tingling |
Numbness and tingling in face within 30 min. after vaccine administration. No other symptoms; no dif...
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Numbness and tingling in face within 30 min. after vaccine administration. No other symptoms; no difficulty breathing, shortness of breath or chest tightness, no facial swelling. Symptoms resolved after about 4 hrs. No medications taken and no treatment.
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| 63 | 2021-03-22 | facial paralysis, bell's palsy |
Patient noticed facial drooping and increased drowsiness. She went to the emergency department on 2/...
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Patient noticed facial drooping and increased drowsiness. She went to the emergency department on 2/19 and was diagnosed with Bell's palsy. She was treated with valacyclovir 1000mg PO TID for 7 days and prednisone 20mg PO TID for 5 days. She completed the course of treatment and as of 3/16/21, symptoms had resolved.
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| 63 | 2021-03-22 | seizure |
The day following the vaccine, the above noted patient had a suspected seizure, the first one of her...
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The day following the vaccine, the above noted patient had a suspected seizure, the first one of her life. Upon investigation at the hospital, there are no signs of any other causation?s of this occurrence. Therefore considering the close proximity of the vaccination, we believe it may be an adverse event that should be reported.
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| 63 | 2021-03-22 | burning sensation |
Unidentifiable taste in mouth w/in 5 minutes, burning sensation bottoms of both feet w/in ten minute...
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Unidentifiable taste in mouth w/in 5 minutes, burning sensation bottoms of both feet w/in ten minutes, lips became numb on way home, (reside 5 minutes away) burning sensation continued to below knees within hour, dissipated during day but not completely. Similar to adverse reaction years ago to Avelox.
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| 63 | 2021-03-22 | numbness |
Within 10 minutes of vaccine administration, pt c/o tongue and lip numbness. Progressed to nose numb...
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Within 10 minutes of vaccine administration, pt c/o tongue and lip numbness. Progressed to nose numbness and palate itchiness. VSS. Lungs clear. 50 mg po Benadryl administered. Within 20 minutes, sx free and d/c home with husband and daughter
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| 63 | 2021-03-23 | difficulty speaking |
10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no s...
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10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no swelling noted to throat/lips/face. Pt's HR 74, BP 150/90. Ambulance called to scene and pt reporting improvement in symptoms upon ambulance arrival. Report provided to Paramedic, pt transported via ambulance to local hospital.
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| 63 | 2021-03-23 | pain in extremity |
3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatig...
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3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatigue on 3-12 & 3-13. On 3-14 developed intense pain right side lower back and kidney. 3-16 went to Doctor as felt I had kidney infection but urine checked find, she thought it was muscle spasms. 3-19 broke out with shingles and back to doctor on 3-22 and given Acyclovir and Gabapentin. 3-23 went to ER. In as woke with pain so severe I broke out in sweat and threw up. Gave me Hydrocodone, nurse commented was worse break out she had ever seen. Internal pain is worse than the rash which is naval to spine and 3 to 4 " wide.
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| 63 | 2021-03-23 | feeling cold |
First felt coldness in elbow region and a little itchy. Nausea about 30 minutes later and coldness ...
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First felt coldness in elbow region and a little itchy. Nausea about 30 minutes later and coldness crept up arms, back and neck
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| 63 | 2021-03-23 | burning sensation |
Pt. stated she felt burning sensation in her left arm, one minute after she got vaccinated, and then...
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Pt. stated she felt burning sensation in her left arm, one minute after she got vaccinated, and then she started feeling palpitations. Vital signs taken. BP 99/56, HR 68, O2 Sat 95%, R 18. At 2:21 pm pt. stated she is feeling better and refused to go to the hospital. At 2:43 pm pt. stated she is OK and wants to go home.
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| 63 | 2021-03-24 | weakness |
2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by...
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2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by severe pain in muscles "all over her body". She had severe headache. She had a fever of 101.9. She had no appetite and "could not eat" . She remained in bed, barely able to walk to the bathroom for 7-8 days. She was "so weak", could not get up. She did not have solid food for 1 week and was not able to take more than sips of liquid. She has continued weakness fever. Now 3 wks following the vaccine, her temp is 100.2.
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| 63 | 2021-03-24 | feeling cold |
Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever o...
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Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever of 99 so I took Tylenol and tried to sleep. Woke with a headache and cold not get warm all night.
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| 63 | 2021-03-24 | weakness |
Next day, March 24: 6:00 am: headache, achy joints, fatigued, feeling "punk" or heavy limbs. 10:00 ...
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Next day, March 24: 6:00 am: headache, achy joints, fatigued, feeling "punk" or heavy limbs. 10:00 am: severe headache, aches and fatigue much worse, in bed and sleeping. 3:00 pm: Added chills. 7:00 pm: Added mild fever (100). Thursday, March 25. Woke up with very mild symptoms, but still fatigued and without energy. 3:00 pm back to normal.
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| 63 | 2021-03-24 | burning sensation |
On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives. Burning right ...
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On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives. Burning right side .. (back) then the shingles 3/22 called doctor...
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| 63 | 2021-03-24 | weakness |
Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating...
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Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating really hard/pounding chest; Weakness; Fast heartbeat/Pounding chest; Lightheadedness; Insomnia; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported). A 63-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 at unspecified route in left arm on 08Mar2021 11:30 as a single dose (at the age of 63 years) at for COVID-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing severe allergy , drug hypersensitivity from an unknown date and unknown if ongoing severe allergy , dysphagia from an unknown date and unknown if ongoing , ongoing Sjogren's syndrome diagnosed 33 years ago , ongoing systemic lupus erythematosus diagnosed 3 years ago , ongoing headache , ongoing intervertebral disc degeneration diagnosed with this about 15 years ago , ongoing fibromyalgia diagnosed 10 years ago , Meniere's disease from an unknown date and unknown if ongoing , supplementation therapy from an unknown date and unknown if ongoing Vitamin c (Verbatim): recommended by dentist bone health and teeth. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from 2020 and ongoing; vitamin d3 (VITAMIN D3) taken for hypovitaminosis from 2019 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for hypovitaminosis from Apr2020 and ongoing; timolol (TIMOLOL) taken for glaucoma from 2011 and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for dyspepsia from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) taken for fibromyalgia from an unspecified start date and ongoing; cetirizine hydrochloride (GENERIC ZYRTEC) taken for hypersensitivity from 2011 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; olanzapine (OLANZAPINE) taken for bipolar disorder from an unspecified start date and ongoing; docusate sodium (COLACE) taken for constipation from an unspecified start date and ongoing; lactulose (GENERLAC) taken for constipation from 2018 and ongoing; acetaminophen (TYLENOL GENERIC) taken for headache, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for intervertebral disc degeneration, headache from Dec2020 and ongoing; triamcinolone diacetate (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) taken for rash from 2018 and ongoing; meclizine hydrochloride (MECLIZINE HYDROCHLORIDE) taken for dizziness, start and stop date were not reported. The patient experienced heart was racing, her heart was beating really hard/pounding chest on 08Mar2021 with outcome of recovered , pale and shaky on 09Mar2021 with outcome of recovered weakness on 08Mar2021 with outcome of recovered , fast heartbeat/pounding chest on 08Mar2021 with outcome of recovered , lightheadedness on 08Mar2021 with outcome of recovered , insomnia on 08Mar2021 with outcome of unknown , blood pressure bottomed out on 09Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 'bottomed out' on unspecified date 09Mar2021, heart rate: 95, heart rate: 98-101, heart rate: fast. Therapeutic measures were taken as a result of , insomnia. No vaccines administered on same date with the Pfizer vaccine. No vaccinations within four weeks prior to the first administration date. No ER visit or physician office visit reported.
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| 63 | 2021-03-24 | cold extremities, depressed level of consciousness |
Pt presented today for 1st Pfizer mRNA COVID vaccine. She received the vaccine at 11:06am and proce...
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Pt presented today for 1st Pfizer mRNA COVID vaccine. She received the vaccine at 11:06am and proceeded to the check out area and scheduled her second appointment and checked out at 11:10am. She was sitting in the secondary seating area, she looked scared, then she indicated to the APP she felt dizzy, eyes fluttered back, and slumped back into the chair and into APP's arms. With the assistance of another RN, we laid her down on the ground and lifted her legs. She was arousable to sternal rub and complained of dizziness. She was able to report her name and that her husband was outside in the car waiting for her, however, she was slow to answer questions and still appeared distressed. We made several attempts to obtain a BP, however, it would not register on machine, O2 sat 100%, HR 42, manual HR 50 at pericordium. Her bilateral upper extremities were cool to touch and appeared mottled. We attempted to give her apple juice just she was only able to take a few sips. We placed her on 100% non-rebreather. Given low HR, unable to obtain BP, and semi-conscious state, we elected to call 911 at 11:30am. Her husband was retrieved and at patient side when EMS responded. He reported that she has fainted in the past with blood draws and has a past medical history of "leaky valve, low platelets" and later it discovered via her medical records that she has a history of seizures and was on vimpat and lisinoril. EMS arrived, assessed the patient, and moved her to stretcher and transported patient at 11:39am.
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| 63 | 2021-03-24 | pain in extremity |
Soreness in Arm started almost immediately. Very tired throughout day. Then around 3:00PM arm got v...
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Soreness in Arm started almost immediately. Very tired throughout day. Then around 3:00PM arm got very sore and hurt to move. At 12:15AM developed severe chills. took tylenol and seems to be working
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| 63 | 2021-03-24 | pain in extremity |
fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barel...
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fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barely move it or sleep on it, tired feels like a mild flu
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| 63 | 2021-03-25 | weakness, pain in extremity |
Eight days following first shot, my arm started itching near the injection location and two quarter ...
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Eight days following first shot, my arm started itching near the injection location and two quarter sized red spots showed up. This lasted a few days. 2nd shot was Mar 18 at 11 am at same facility. Had severe arm and shoulder blade pain the remainder of the day. Used an ice pack. Mar 19 had slight fever in the morning. Severe arm pain had resolved. Severe achiness in lower back and jaws and general achiness. Started taking Tylenol in afternoon. Vomited at 6pm and 10:30pm. Mar 19-21: Severe headache. Barely ate Mar 19-20. Stayed in bed or resting on couch. Experienced intermittent hiccups. No energy. Headache resolved. Mar 22. Mar 26. Still don't feel 100% normal energy level, but pretty much resolved
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| 63 | 2021-03-25 | discomfort |
Five min. after injection: Pulse raced for short period of time (15 sec), during that time felt pre...
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Five min. after injection: Pulse raced for short period of time (15 sec), during that time felt pressure in left wrist, later that day experienced large bruise on the on the left wrist,
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| 63 | 2021-03-25 | nerve pain |
I began to experience very painful nerve pain in my body, most noticeable in my feet area making it ...
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I began to experience very painful nerve pain in my body, most noticeable in my feet area making it painful to walk. I had been exercising and after the Pfizer covid vaccine shot, it hurt too much to exercise.
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| 63 | 2021-03-25 | pain in extremity, tenderness |
Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd...
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Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd vaccine & got worse through the night. Couldn?t sleep, left arm & left side of neck were sore & hurting in the beginning, then spread to my entire body. (1st vaccine 3 weeks before, no problems except my left arm was sore for a day.) Took ibuprofen & alprazolam before getting in bed & it seemed to help for a short time. My nerves felt like they were on top of my skin. Didn?t sleep much at all, maybe couple hours. Now, 3pm the next day, I?m still very sore, tender all over my body.
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| 63 | 2021-03-26 | pain in extremity | Fever 101.8, achy legs, face extremely red and hot, headache, nausea |
| 63 | 2021-03-26 | pain in extremity |
Monday pm had very sore arm. Tuesday, I had a temp of 99.9 (my normal is 97.8), all over body aches,...
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Monday pm had very sore arm. Tuesday, I had a temp of 99.9 (my normal is 97.8), all over body aches, and fatigue . This lasted 24 hours. Wednesday everything was gone except the fatigue. Thursday I was back to normal. I took Tylenol on Tuesday.
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| 63 | 2021-03-26 | pain in extremity |
Muscle ache in both power legs. Bottom and top of right foot extremely painful to walk. Bottom left...
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Muscle ache in both power legs. Bottom and top of right foot extremely painful to walk. Bottom left side of left foot extremely painful. Calves muscles on right leg extremely tight. Top of right foot extremely tight and painful.
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| 63 | 2021-03-27 | tingling |
0925 pt reported feeling dizzy and lightheaded with blurry vision while sitting for 15 minute post ...
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0925 pt reported feeling dizzy and lightheaded with blurry vision while sitting for 15 minute post observation time. transported via wheelchair to observation area and placed on gurney in trendelenburg position. 0930 BP 156/84 P 121 pox 96%. 0945 pt reports feeling "better" BP141/73 P 103 , placed in supine position. 0950 placed HOB at 45 degree angle with pt reports feeling "well". BP 167/83 P 83. 0956 pt report feeling "heavy headed and vaccine arm tingly" . Drank 3 oz water. Pt reports being T2 diabetic on metformin. did not check BS this am, but ate breakfast as routine. Reports not regularly checking BS with breakfast. Primary care provider called and spoke with pt. at clinic. PCP advised pt to return to home and self monitor and contact their office if not feeling well today. Husband present and verbalized understanding along with pt of PCP instruction . PT reports BP is occasionally high when anxious. 1010 Pt sitting in chair and feeling well w/o furthur c/o dizziness or blurry vision or heavy headedness . States "feeling good to leave". BP 165/81 P 85 pox 96%. Pt left on foot with husband.
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| 63 | 2021-03-27 | tenderness |
7 days after my first vaccine my arm got swollen, a little tender and itchy. I had the typical sore...
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7 days after my first vaccine my arm got swollen, a little tender and itchy. I had the typical sore arm immediately after the injection for about 48 hours and it went away.
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| 63 | 2021-03-27 | pain in extremity |
Left arm pain for 1-2 days after both shots; headaches after 1st shot (3/5/2021), worsening of left ...
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Left arm pain for 1-2 days after both shots; headaches after 1st shot (3/5/2021), worsening of left jaw pain due to TMJ dysfunction after 2nd shot
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| 63 | 2021-03-27 | seizure |
Patient received CoVID vaccine #1 in drive thru lane. Approx 10minutes after vaccine patient driver...
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Patient received CoVID vaccine #1 in drive thru lane. Approx 10minutes after vaccine patient driver reported something was wrong with patient. When patient was assessed, it appeared she was having a seizure. Medical alert called. Driver stated patient had history of seizures, but was not a good historian of medical information. EMS transported patient to ED.
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| 63 | 2021-03-27 | tingling |
severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss i...
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severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .
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| 63 | 2021-03-28 | feeling hot |
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (...
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Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
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| 63 | 2021-03-28 | feeling cold |
At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30...
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At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30 minutes, I began to get chills and felt very cold. Took two Tylenol and went to bed. Fell asleep and slept approximately 5 hours. Woke up feeling very tired but not chilled or headache. Ate soup and a grapefruit. Went back to bed and slept until approximately 06:30 the next morning. I felt great except for the soreness around the injection site. The injection site showed no evidence of swelling or redness at any time.
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| 63 | 2021-03-28 | cold extremities |
Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands ...
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Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands Vital Signs: B/P: 140/88 HR:63 Resp.: 20 O2Sat:99 Skin Signs: Warm and Dry Circulation: Cap Refill <2Sec Resp.: Breath Sounds Clear Bilaterally Treatment: 11:40 symptoms subsiding, improvement noted. Reassessment @11:45 Vitals: 132/84 HR:60 Resp.: 20 O2Sat: 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath sounds clear bilaterally Treatment: Advised patient to call 911 if symptoms return or notify PCP. Symptoms resolved at 11:45, encouraged to monitor symptoms, encourage hydration throughout the day. D/C home by self
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| 63 | 2021-03-28 | tremor |
had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since ...
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had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
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| 63 | 2021-03-28 | muscle spasms |
sudden back and muscle spasms lasting 2-3 weeks, mild overall but persistent and reported back to us...
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sudden back and muscle spasms lasting 2-3 weeks, mild overall but persistent and reported back to us as PCP clinic. Seemed to resolve by shot 2 on 2/11/21
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| 63 | 2021-03-30 | hot flush, feeling cold |
Thyroid test spiked; Hot and cold flashes; Hot and cold flashes; Tired; This is a spontaneous report...
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Thyroid test spiked; Hot and cold flashes; Hot and cold flashes; Tired; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Mar2021 (Sunday) 18:30 (Lot Number: EN6205; Expiration Date: 30Jun2021) (at 63-year-old) at single dose in arm right for COVID-19 immunization. Medical history included mitral valve and atrial valve leaking from last year (2020), thyroid removed. No additional vaccines administered on same date of BNT162B2, no prior vaccine within 4 weeks, and no family medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration Date: 30Jun2021) on 14Feb2021 18:30 at single dose in the right arm for COVID-19 immunization. She noticed on "Monday" (08Mar2021) she had some hot and cold flashes and she felt tired, which went away the same day. They always checked blood test for thyroid levels randomly because she had her thyroid removed in the past. It has been three months since the last test and the nurse called her "today"/ "this morning" (09Mar2021) to report the result was spiked (thyroid test spiked). She didn't know the actual result, just it was spiked. She usually took 125 mcg levothyroxine sodium (SYNTHROID) once daily by mouth. The events didn't require a visit to physician or ER, and no other relevant test. The outcomes of events tiredness, hot and cold flashes was resolved on 08Mar2021, while of event thyroid function test abnormal was unknown.
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| 63 | 2021-03-30 | feeling hot, tremor |
feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, n...
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feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; heart rate started pounding; lightheaded and dizzy feeling; shaking all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in arm left on 02Mar2021 12:45 as a single dose (at the age of 63-years-old) for covid-19 immunisation. Medical history included high blood pressure that was treated with metoprolol from an unknown date. The patient had known allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medications included metoprolol succinate taken for high blood pressure, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone and ciprofloxacin and experienced drug allergy. At about 25 minutes after receiving the vaccine (02Mar2021 13:15 as reported), the patient had a feeling of extreme warmth or heat in the center of her chest (about where her sternum was). It was a sudden feeling that started radiating outward, seemingly along her arteries and at the same time, her heart rate started pounding, accompanied by a lightheaded and dizzy feeling. The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related. It wasn't a panic attack either. The patient started shaking all over while was driving up and immediately looked for a place to pull over, and began texting someone close by (her brother) to let him know what was happening. No treatment was received for the reported events. The reported events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.
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| 63 | 2021-03-31 | breast pain, pain in extremity, tingling |
Tingling on her lip/ zap or electrical like feeling in her upper lip; tingle on the right hand finge...
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Tingling on her lip/ zap or electrical like feeling in her upper lip; tingle on the right hand finger/ electrical feeling; sharp pain in her breast/ painful zinging sensation on her right breast; excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf; pain that came up the outside left ankle/ zinging sensation left ankle; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in the left arm on 02Mar2021 11:00 AM as a single dose for COVID-19 immunisation. Medical history predating treatment with the Pfizer COVID 19 vaccine included fracture on that left foot where the toenail came off and she had a wound that wouldn't heal. She was fully recovered from the foot injury in Dec2020. Then she came down with a positive COVID 19 test on 11Dec2020. Symptoms started on 07Dec2021 with a fever and everything and she ended up in the ER with bilateral pneumonia and they sent her home on 17Dec2020. Then later, she was admitted to the hospital on 25Dec2020 with excruciating pain in her chest, lungs and legs; and she was having shortness of breath. She was found to have a DVT, PE and bilateral pneumonia. She was discharged 30Dec2020. She thinks she has the long time syndrome after COVID. She was still having shortness of breath, itchiness, and extreme fatigue from the COVID 19 infection but her HCP advised her to get the COVID 19 vaccine anyway. She thinks the chest congestion and cough were cleared up now, but she has noticed hair loss. The patient had no concomitant medications. The patient stated that her husband, son and herself received the first dose of the Pfizer COVID vaccine on 02Mar2021. They all waited the 15 minute waiting period after receiving the vaccine for a reaction and was fine. Her husband and son went ahead to the car and she went to use the restroom. 20 minutes later, while in the restroom, she got a random ting outside her left foot like an electrical type very painful pain that came up the outside left ankle, leg, and calf. She had an excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf/ zinging sensation left ankle on 02Mar2021. The pain was from the same foot that she had broken before. It happened once and she was like what was that and then it stopped. Maybe 5 seconds went by then it happened again this random zap of electrical feeling that she cant really explain but it gave her whole body goosebumps. It did it 5 times in a row with pauses in between in the same exact place left lower leg. After it stopped and as she was washing her hands she had a really sharp pain in her breast on 02Mar2021 and then that was it. She walked out to the car and she didn't say anything to her husband or son because she didn't really understand what was happening and she felt fine other than the crazy pain and once it ended it ended. When she got home and in the afternoon because she was home working remotely it happened again the same exact spot left lower leg and the pain was excruciating when it was happening. This time she thinks it was four times in a row with pauses in between same exact spot just in her left lower leg. This time she told her husband "I didn't say anything before but its happening again and its weird." She never had this feeling before. Adds it was so excruciating. She was just holding her breath counting how many times it will occur. It happened again that night and then she almost afraid to go to sleep because the pain would wake her up but nothing happened as she slept. She woke up the next morning and had to go to an ophthalmologist appointment and happened again while she was sitting in the chair. She had another episode of the painful zing in her foot. That was the last time it did and it might have happened again but altogether she had 4-5 episodes in a 24 hour period after receiving the vaccine. Each time she would have several painful zings. She also noticed a tingling on her lip on 03Mar2021; a painful zinging sensation on her right breast; and a tingling sensation on one finger of her hand that happened one time on 03Mar2021. That day, she had a tingling in one finger and a zap or electrical like feeling in her upper lip and that was it those didn't really bother her they were more tingling and electrical feeling. She called her primary doctor and he hadn't heard of anything like it before but he cant rule it out. He said the only way you would know is if you got the shot again but she states she is a little scared. She would like to know if this side effect has been reported before and if she should get the second dose of the vaccine. She was scheduled to receive the next dose on next Tuesday, 23Mar2021. She mentioned she had blood work this week but she has no results at this time. The outcome of sharp pain in her breast/ painful zinging sensation on her right breast was recovered on 02Mar2021, of excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf was recovered on 03Mar2021, of pain that came up the outside left ankle/ zinging sensation left ankle was recovered on 04Mar2021, of tingling on her lip/ zap or electrical like feeling in her upper lip was recovered on 03Mar2021, and of tingle on the right hand finger/ electrical feeling was recovered on 03Mar2021.
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| 63 | 2021-03-31 | pain in extremity, nerve pain |
Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple ...
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Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple of days with no relief. Went to ED Triage nurse to ask for guidance on next steps. Went to urgent care on 3/15/21 and was prescribed muscle relaxers for muscle pain with no relief in my shoulder and arm. Appointment with orthopedic doc, on 3/17/21. He ordered an MRI of C-spine and diagnosed nerve pain. Pain traveled from arm to hand and back to shoulder then repeated 24/7. Used ice-packs, and alternated with heat. Second appointment with Dr. on 3/23/21. Discussed nerve pain and Parsonage Turner Syndrome.
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| 63 | 2021-04-01 | bell's palsy |
onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue,...
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onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-01 | muscle spasms, weakness, feeling cold |
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso...
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rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-04-07 | pain in extremity |
Only initial side effect following both injections was moderately sore arm and fatigue. Following 2...
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Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.
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| 63 | 2021-04-09 | tenderness |
Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, ...
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Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, anorexia, bladder irritation-persistent
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| 63 | 2021-04-09 | pain in extremity |
arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a li...
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arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 63 | 2021-04-09 | pain in extremity, muscle spasms |
pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circ...
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pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.
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| 63 | 2021-04-09 | weakness |
sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weak...
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sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weakness; lower abdomen hurt; tired; vomiting; diarrhea; sweaty; little bit of rectal bleeding after diarrhea; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Left upper arm on 24Mar2021 (Batch/Lot number was not reported; Time the Vaccination Was Given was around 15:30) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid, renal disorder from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, blood pressure measurement from an unknown date and unknown if ongoing, vaginal disorder from an unknown date and unknown if ongoing, colitis from an unknown date and unknown if ongoing. Reported following prior vaccinations was stated she had a sore arm sometimes with the flu shot and felt kind of sick but not always. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid from an unspecified start date and ongoing (reported she started taking this decades ago); metformin (METFORMIN) taken for diabetes from an unspecified start date and ongoing ((reported she started taking this decades ago); lisinopril (LISINOPRIL) to protect kidneys with diabetes and for blood pressure, started years ago and took a small dose, stated her blood pressure was usually fine; estradiol (ESTRACE) taken for when the vaginal tissues get disintegrated from an unspecified start date and ongoing (stated she started this a very long time ago). The patient experienced little bit of rectal bleeding after diarrhea on 25Mar2021 with outcome of unknown, sick on an unspecified date with outcome of unknown, tired on 25Mar2021 with outcome of not recovered, vomiting on 25Mar2021 with outcome of unknown, diarrhea on 25Mar2021 with outcome of unknown, sweaty on 25Mar2021 with outcome of unknown, exhausted/wiped out on an unspecified date with outcome of unknown, stomach kind of hurts on 25Mar2021 with outcome of unknown, started to feel lousy on 25Mar2021 with outcome of unknown, tiny bit of dizziness on 25Mar2021 with outcome of not recovered, weakness on 25Mar2021 with outcome of unknown, lower abdomen hurt on 25Mar2021 with outcome of unknown. The event little bit of rectal bleeding after diarrhea considered serious as medically significant. The AEs not require a visit to Emergency Room or Physician Office. Received the first dose of the Pfizer Covid 19 vaccine Wednesday afternoon, yesterday, patient felt okay, but was off, got really sick in the middle of the night. during the day , tired, expected that, but at night vomiting, diarrhea and weak, sweaty, kind of bad. it stopped today she was just exhausted and her stomach kind of hurts. She was better than last night, today she was just more worn out by this, she took a Imodium. She had the vaccine Thursday afternoon and yesterday she felt lousy, nothing severe and last night she was very sick. Stated she was still trying to get better today. Stated she called and left a message with the FDA/CDC vaccine adverse event reporting system a little while ago. Caller clarifies she got the vaccine on Wednesday 24Mar2021 and that she started to feel a little lousy 25Mar2021, more like the symptoms that are described, she was tired and had a tiny bit of dizziness that came and went, it was mostly tired. Stated in the middle of the day she laid down for an hour and that was around lunch time. Stated the dizziness was off and on like when she was driving and just here and there. Stated the tired was still persisting. She stated she did not have NDC, lot, expiry date or dose to provide. Stated she see EUA on the sheet but not much else. Stated it was the 1st dose. Stated she forgot to tell about last night. Stated she woke up around midnight very sick with vomiting and had diarrhea and was sweaty. Stated her stomach hurt and her lower abdomen hurt. Stated she was not sure if these are from the vaccine or a coincidence. Stated she had stopped throwing up, just did that a few times. Stated the diarrhea stopped after a little while. Stated she still has abdominal pain today and weakness was with the diarrhea and she would lay down in bed. Stated she was still a little weak, that she was more wiped out and tired. Caller stated she was bleeding a little bit after the diarrhea and it scared her because a couple years ago she had colitis and it scared her, that she called a relative who is a retired nurse and she thought it was from the diarrhea. Caller clarified she contacted her relative about this current event with the bleeding. Caller provided that she took Imodium this morning and has been sipping on water and had a little breakfast, she thought she may be a little dehydrated. Patient stated her symptoms were pretty bad last night, it was acute. Patient clarified that it was rectal bleeding and it was just a little this morning. Stated it happened last night and again this morning. Stated she was not sure if it was still occurring and hopes it stopped as it it's scary. Stated today she was just resting and trying to get better. Patient said that if it gets worse she will call her doctor and that she had called the hospital last night and they didn't have anything to say. Stated that if it was from the vaccine she was hoping that it's very temporary and went away and be gone if it was from the vaccine. Patient was asking if there was information about the chance that this was related to the vaccine, stated they were not listed as possible side effects. Stated she had people from the hospital and relatives she has talked to that say it may be. Information on the lot/batch number has been requested
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| 63 | 2021-04-11 | pain in extremity |
12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on...
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12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on 4-7-21, my left leg calf was very sore and hard for me to walk, Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf. (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)
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| 63 | 2021-04-11 | weakness | Severe headache, nausea, weakness, fever and chills. Only headache remains 2 days later. |
| 63 | 2021-04-13 | muscle spasms |
2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg ...
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2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg and ankle. 3/9/21 Work clinic advised to seek medical attention 3/9/21 Hospital Emergency Room Diagnosis: Deep Vein Thrombosis (DVT)- Blood Clot 3/10/21 Thrombectomy Surgery & Released 3/11/21 Swelling in right leg and ankle Returned 3/12-16/21 Readmitted - Blood Clot returned Currently under several doctors care.
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| 63 | 2021-04-13 | bell's palsy, facial paralysis | Bell's palsy. Developed L facial droop on 3/29/2021; COVID vaccines on 1/16/2021 and 2/8/2021. |
| 63 | 2021-04-15 | weakness |
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine sit...
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Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat. Also, broke my knee cap 2 years ago and it had become painful
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| 63 | 2021-04-17 | pain in extremity |
has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart ra...
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has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.
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| 63 | 2021-04-18 | weakness |
Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third...
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Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.
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| 63 | 2021-04-18 | pain in extremity |
intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up...
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intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.
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| 63 | 2021-04-18 | facial paralysis, numbness |
left side face numb, drooping, couldn't move it, stroke ruled out, appeared to be symptoms of Bell's...
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left side face numb, drooping, couldn't move it, stroke ruled out, appeared to be symptoms of Bell's palsy
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| 63 | 2021-04-24 | facial pain, cold extremities, pain in extremity |
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ...
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Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
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| 63 | 2021-04-24 | pain in extremity |
Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make...
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Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands; pain in arm; right ear & head pains; right ear & head pains; This is a spontaneous report from a contactable nurse, the patient, and based on information received by Pfizer from Abbvie Pharmacovigilance (Mfr. Control No.: 21K-163-3848385-00). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6207) intramuscular in the right arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization; adalimumab (HUMIRA) solution for injection, subcutaneously, from an unspecified date at an unspecified dose and frequency for rheumatoid arthritis (RA). Medical history included polymyalgia rheumatica (PMR), RA, hypothyroidism, anemia. The patient had no known allergies. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included prednisone, levothyroxine sodium (SYNTHROID), folic acid, calcium carbonate (CAL). The patient did not receive any other vaccinations within 4 weeks of BNT162B2. On 18Mar2021 (within 4 hours of the vaccination), the patient experienced a rheumatoid arthritis flare up. The clinical course was as follows: on 18Mar2021 at 15:00, the patient experienced pain in elbow and finger pain (like trigger finger of both hands). On Mar2021 (within 24 hours), all fingers were involved, the patient's grip strength was decreased (she could not make a fist or grasp or grip/ inability to grip or grasp with her hands) and experienced left wrist pain. On Mar2021 (within 48 hours), the patient experienced finger edema, was still unable to make fist or grasp, experienced painful shooting pains up inner arms, right ear & head pains. The patient increased the prednisone dose to 4 mg daily as treatment for the events. On 21Mar2021 at 11:00 (72 hours after vaccination), the patient continued to experience bilateral arm pains, slight hand grips but could not lift, new right knee and right outer foot pains. On 21Mar2021 (94 hours after vaccination), there was less arm pain and finger edema, continued right ear/head pains. The patient saw the primary physician, there was no ear infection and the physician agreed with the prednisone increase. The physician felt the patient should not take the second vaccine dose and alerted the rheumatologist. On 22Mar2021 (116 hours after vaccination), the patient was able to lift and grasp with both hands, had less ear and arm pain. Since the vaccination, the patient was not tested for COVID-19. The action taken with adalimumab in response to the events was unknown. The reporter's causality for the events trigger finger, inability to grip or grasp with her hands, severe flare of RA symptoms 4 hours post vaccine, pain in arms and elbows, pain in ears was not provided. The clinical outcome of rheumatoid arthritis flare up, trigger finger, "grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands", pain in arm, right ear & head pains was resolving; while of pain in elbow was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the RA flare and other events. The reported events may likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 63 | 2021-04-24 | numbness, weakness, tingling, pain in extremity |
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach...
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some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-26 | feeling hot |
welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, ho...
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welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, hot, and itchy; This is a spontaneous report from a contactable consumer(patient).A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none.Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,lot number EM9810) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation, anatomical location was left upper arm muscle. There were no concomitant medications.Patient was took second dose of vaccine on 09Feb2021 and on 12feb2021, night her ears were real hot, she had no other symptoms at all with the vaccine, no headache or fever, her ears were red, hot, and itchy, welts on face are still there and itchy, and her neck, and on 15feb2021, she has 2 spots on two fingers, they have itchy spots on them, little bump on each one. She wondered if this was related to it, it was 3 days after the vaccine, that it started. She was not sure this was an experienced, she was curious to know if it was a side effect. Family medical history relevant to AE was none. she has taken some Benadryl. The outcome of the event was unknown.
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| 63 | 2021-04-27 | pain in extremity, hot flush |
sore arm; hot flashes have come back; This is a spontaneous report from a contactable consumer (pati...
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sore arm; hot flashes have come back; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient (Non-Pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 08Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced sore arm hot flashes have come back. No treatment was received for the event. The outcome of the event was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 63 | 2021-04-28 | pain in extremity, cold extremities, slurring |
Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she ...
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Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she cannot write or type; arm was sore; she sounded different; they said her speech sounded slurred; was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4; was not able to walk at first; her arm was cold; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 24Feb2021 08:00 (at the age of 63-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure that was diagnosed 2-3 years ago, diabetes; she was prediabetic, heart;cholesterol has been high for about 30 years; since she was in her 30s; all from an unknown date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 02Feb2021 (at the age of 63-years-old) for covid-19 immunization. The patient had no prior vaccination in four weeks. Concomitant medications included rosuvastatin taken for blood cholesterol and takes 20mg once a day prior to stroke and in the hospital they increased it to 40mg once a day and ongoing; ramipril taken for blood pressure and she was prescribed with this medication for a while prior to her stroke. It was discontinued in the hospital. Stated that she did not take it everyday because she was allergic to it; and sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes from an unspecified start date and ongoing and stated that she has been taking for quite a while. On 24Feb2021 she had her second shot. She said that everything was fine that morning; that afternoon her arm was sore. Stated she thought nothing of it. That evening she entertained guest. They were saying she sounded different; they said her speech sounded slurred. She had gotten her vaccine at around 08:00. Again, she didn't think anything about her speech. On 25Feb2021, she got up and did some laundry going up and down the steps. Stated that it was difficult because her arm was still sore. She cleaned the house. At around 15:30 she was doing bills and noticed that her writing looked like a baby's scribble. On 26Feb2021, she noticed that her left arm was weak and was told by her doctor to go to the Emergency Room where they told her she had a stroke. She added that it seemed like her arm was cold for a number of weeks. Stated she was the type to wear t-shirts in the winter because she was always hot. During those weeks she was wearing heavy clothes and was under blankets. She was just now starting to feel more like herself and not so cold all the time. The patient was unable to recall time frame when this symptom began. The events did require a visit to emergency room and physician office. The patient was hospitalized for 4 days due to the events from 26Feb2021 to 01Mar2021. During hospitalization, the patient saw a cardiologist, neurologist, her primary care provider, and the hospitalists who all said it was very suspicious that her stroke happened right after her vaccine. Before she got her second vaccine, she was doing embroidery and everything she normally does; nothing was wrong. They did a CAT Scan that showed nothing. Then the MRI of the brain showed a Pontine Stroke on 26Feb2021. Cardiologist put a heart monitor on her and could not find anything. They were looking for A-Fib or something like that when she was on the heart monitor in the hospital; but it never showed anything irregular. She had a loop recorder implanted to monitor her heart and they haven't found anything wrong on it. She had heart tests, carotid artery tests, ultrasound of her heart and nothing was found on those tests. They pretty much told her in the hospital that they couldn't find a reason for her stroke. She kept asking about the vaccine. They did not rule it out as a cause, but they also did not say it was the cause. All the doctors said they could not pin her stroke on the vaccine. They stated it was suspicious and that they had seen 2-3 other patients with a similar situation. One of the doctor's told her he would not rule it out. They did an ultrasound of her carotids and heart and did not find anything on those tests that would have caused her stroke. She was having lasting effects related to her stroke. Her arm was still sore at times, stated it was a different kind of sore and could be related to all the therapy she does now. The lingering effects after stroke was reported as she was not able to walk at first. She's been doing therapy focused on her left side. Stated that her left side was the dominant side and she cannot write or type. She couldn't do the report online due to the difficulty with typing. She wanted to make sure this was reported. The patient has been doing therapy for 7 weeks, twice a day; and stated she likely still has months more of therapy to try and get her left side back to normal. She said that simple daily duties are difficult. The patient also stated that she was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4. She doesn't know what made it go up. Then states she doesn't know if the vaccine made it go up or not. She has a follow up with the neurologist soon. The patient also reported medications she has been taking since her stroke and hospitalization; but not prior to her vaccine which included Amlodipine-Benazepril: 5-20mg once a day and Aspirin: 325mg once a day. The patient stated that stroke and heart problems do not run in her family. The outcome of the events was unknown.
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| 63 | 2021-04-30 | weakness, migraine, cold extremities, pain in extremity, tremor |
she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking...
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she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking bad; got chills shaking bad; muscle aches, even in her fingers; Feet being Ice cold; no energy; dizzy; This is a spontaneous report from a contactable consumer(patient). A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8737, expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021(between 10:15 and 10:30) at single dose for covid-19 immunisation. The patient's medical history included COVID in 2020(had the COVID virus about a week and a half before Christmas/had COVID in the past). Concomitant medications included two unspecified medications. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient was calling about the Pfizer COVID shot. The patient stated she received her 1st shot on Tuesday(13Apr2021) and she didn't know if you have had the COVID virus you weren't suppose to take the shot. She stated that she had the COVID virus about a week and a half before Christmas. The patient stated that she went through a vaccine drive thru and after she got the shot, by time she drove around the corner to park her car, she was dizzy. The patient stated that around 8 o'clock Tuesday night, her right arm was so sore, she stated that she got the shot in her right arm because she uses that arm more. The patient stated her arm got real sore, she had a migraine headache, she got chills and was shaking so bad on 13Apr2021. She had never had chills like that before. Her muscles were aching real bad, it was aching even in her fingers, they were hurting on 13Apr2021. The patient stated that the bottoms of her feet were ice cold on 13Apr2021. She had nausea on an unknown date. She stated that she had the same symptoms as when she had COVID, except the lack of taste and smell. The patient stated that she has no energy on 13Apr2021. She says now, she is afraid to get the second shot because she hears it is worse than the first shot. She stated that still today, she has no energy what so ever. The patient stated she thought she was dying from the first shot on an unknown date. She was scared to take the second one. The patient confirmed she got her 1st dose on 13Apr2021. The patient stated the dizziness started 5 minutes after getting the shot. She said she didn't pay much attention to when it stopped but it was probably later on in the afternoon. The patient said that the dizziness was really noticeable when she was sitting in the car. The patient said her arm is still sore. She said that it is not as sore. She said that on Tuesday it hurt to move her arm but now it is just sore to the touch. The patient stated that her headache, last night started easing off and she woke up this morning and it was gone. The patient stated that the chills and shaking are much better but she still gets cold and then she gets warm and then cold again. The patient stated she took Aleve because her head, and it was easing up before she went to bed, she took Aleve for the pain and headache and she woke up and it was gone. She stated that she is a little better but still doesn't have a lot of energy. The patient stated she was on two medications but it's not for COVID. The patient stated the facility gave her paper work, and she filled out the paper work and she told them that she had COVID in the past on the paper work. No Emergency Room or Physician Office visit was required for the events. The outcome of the events "she was dying from the first shot" and "Nausea" was unknown, of the event " dizzy" was recovered on 13Apr2021, of the event " Migraine headache" was recovered on 15Apr2021, of the event " muscle aches, even in her fingers" and "Feet being Ice cold" was recovered on 14Apr2021, of the other events was recovering.
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| 63 | 2021-04-30 | weakness, pain in extremity |
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has...
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stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
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| 63 | 2021-05-03 | migraine |
passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a...
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passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 12Apr2021 (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included High cholesterol, hypothyroidism. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 63-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 18:30 (Lot Number: ER8727) as single dose for covid-19 immunisation. The patient was not pregnant. The patient experienced migraine, chills, aches, slight temp and tired on 13Apr2021 10:00; passed out at home 22:30 13Apr2021. No treatment received. The outcome of the events was recovered in Apr2021.
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| 63 | 2021-05-07 | muscle spasms, feeling hot, tingling, pain in extremity |
DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right sh...
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DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
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| 63 | 2021-05-10 | feeling cold |
On the floor in the store; Whole left side; radial pulse and everything was gone; Freezing, could no...
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On the floor in the store; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is spontaneous report from contactable consumer. A 63 years old female patient reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9269) on 05Feb2021 12:30 at right arm for COVID-19 immunization. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed in 2019 and ongoing asthma diagnosed in 2019. Family history included some heart problems and cancer. Concomitant drugs were not provided. She says she waited the 15 minutes after the vaccine and felt fine. She then went to the store. She ended up on the floor at the store, her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She was freezing and could not get warm. They put warming blankets on her. She had to be taken out of the withheld by ambulance; she thought she was having a stroke. All of her tests at the hospital were negative. They did a MRI and a CT Scan and everything was fine. The time she got her vaccine to the time they had to call the ambulance was about an hour. They symptoms lasted a couple of hours, then they were gone. She states that at that time Pfizer was saying to wait two weeks between the first and second vaccine; because of her event she was told to wait three weeks. States that she missed that vaccine because her son passed away. She didn't know if she has to start over again with the first vaccine; or if she can just go get the second vaccine that she missed. Her experience with the first one was scary; but her tests were all negative. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. The patient stated that the Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The Emergency Room doctor told her that he wouldn't get it if he had a reaction like hers. The outcome of the events was recovered on 05Feb2021. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-05-11 | feeling cold, numbness |
she ended up on the floor at the store; Whole left side; radial pulse and everything was gone; Whole...
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she ended up on the floor at the store; Whole left side; radial pulse and everything was gone; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 12:30 (Lot Number: EL9269) 1ST DOSE, single for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and asthma. There were no concomitant medications. The patient not received prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. The patient reported that she received her first vaccine dose on 05Feb2021 and initially was instructed to get the second dose 2 weeks later. 30 minutes after getting the first dose she experienced a reaction, she thought she was having a stroke and she was transported to the ER for evaluation and found out it wasn't a stroke. Reports that because of her reaction, her ER doctor advised her not to get the second dose. But her primary doctor advised her to get the second dose at 3 weeks instead of 2 weeks after the first. She was planning to get her second dose 3 weeks after the first dose but her son died and she missed her appointment. Since then she has relocated to other state. It was further reported as follows: she waited 15 minutes after the vaccine and felt fine. She then went to the store and ended up on the floor at the store and had to be taken out of the store by ambulance. Her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She thought she was having a stroke but all of her tests at the hospital were negative. She was freezing and could not get warm. They put warming blankets on her. They did an MRI and a CT Scan and everything was fine. Symptoms lasted a couple of hours, then were gone. Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The patient wants to be fully vaccinated. From the time she got her vaccine to the time they had to call the ambulance, it was about an hour. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. Outcome of events recovered on 05Feb2021.
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| 63 | 2021-05-13 | nerve pain |
immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not f...
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immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks. On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
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| 64 | 2021-01-02 | facial paralysis |
Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen...
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Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen at pharmacy. Swelling increased overnight up into right cheek and jaw. Right side eye and cheek and mouth drooping with a crooked smile. On 01/02/2020 started itching from up under right ear down towards neck with redness and hives. Got RX from pharmacy for Prednisone and am currently taking that
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| 64 | 2021-01-03 | numbness |
By evening of the same day I read the vaccine my right side got numb my cheek and eye hurt to the to...
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By evening of the same day I read the vaccine my right side got numb my cheek and eye hurt to the touch, my eye socket was very sore, like if I was getting Bells Palsy. I took Vitamin B12 sublingual and went to bed and the next day it was still sore but I took the vitamins again and later on it subsided. By the first of the month those symptoms were a lot less and now I am fine.
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| 64 | 2021-01-05 | weakness, pain in extremity |
I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness o...
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I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.
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| 64 | 2021-01-05 | feeling cold, pain in extremity |
Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hiv...
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Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine. Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home. There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better. Symptoms were most mild because she was still able to function. Clarified as not serious. The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red. Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
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| 64 | 2021-01-05 | tenderness |
a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a conta...
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a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a contactable nurse reported for her identical twin sister. A 64-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified flu vaccine on 18Dec2020. The patient experienced a slight chill the first night and slight tenderness to arms on 28Dec2020 with outcome of unknown. Information about Lot/Batch number requested.
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| 64 | 2021-01-06 | weakness |
At twelve hours post injection I awoke with severe chills even though I did not have a temperature. ...
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At twelve hours post injection I awoke with severe chills even though I did not have a temperature. After taking 1000 mg of Tylenol the chills past in approximately an hour. The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite. By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.
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| 64 | 2021-01-06 | discomfort |
Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and ...
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Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.
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| 64 | 2021-01-07 | hot flush |
Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an...
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Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an 1hr in a half I had high blood pressure it started 20min after the vaccine
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| 64 | 2021-01-08 | pain in extremity |
Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should ...
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Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.
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| 64 | 2021-01-08 | flushing | Flushing Narrative: Flushing 10 minutes after vaccine administration |
| 64 | 2021-01-08 | pain in extremity | headache, sore arm, fever, body aches, tiredness |
| 64 | 2021-01-09 | feeling cold, feeling hot, tremor |
About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within...
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About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within 30 minutes I began to shiver. This intensified and I got to the point I was shaking hard and so cold. I had also had a headache all day but that is not unusual for me as I frequently have sinus headaches that can last all day. I took my temperature which was 98.3 but I took Tylenol anyway realizing I was likely having a vaccine reaction. I got into bed under my electric blanket. Ninety minutes later I had finally warmed up. In fact my feet and hands felt like they were on fire. I rechecked my temperature and it was up to 100.9. I peeled off my numerous clothing layers and I actually felt better since the chilling had stopped. I ate some dinner and watched TV and went to be around 11pm. I slept fitfully which is normal for me. As the night wore on I began chilling again. I got up sometime around 5am and took more Tylenol. If I remember my temperature was around 100.1. I slept several hours and woke up feeling ?back to normal?.
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| 64 | 2021-01-09 | pain in extremity |
Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu l...
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Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu like feeling
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| 64 | 2021-01-09 | pain in extremity | Fever (oral temp 100.5) Body Aches Chills Headache Fatigue Right arm pain |
| 64 | 2021-01-10 | hot flush |
20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continue...
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20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continued for 1.5 hrs, however hot flush, dizziness and blurred vision Lt eye resolved.
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| 64 | 2021-01-10 | flushing |
As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple ye...
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As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple years ago. PCP discussed benefit to prevent complications of COVID vaccine outweighs risk to get COVID vaccine. Discussed this as well with patient. She agrees to get the vaccine. I stayed with the RN and patient for 30 minutes post vaccination and she had no symptoms other than BP and Pulse elevated further to 150s/90s. P upper 80s. She was transitioned to anther office with plan to continue observation for another 15 mins and recheck her BP. About 45-50 mins post vaccine, she reported her lower arms and right side of her neck felt swollen but had no SOB or mouth swelling or itching. She was talking in normal sentences. Her face became more flushed as well as the posterior aspect of her forearms and she said the neck felt more swollen. Epi Pen was administered at 8:40 am and EMS was contacted. Her BP was 160/100, pulse ox 96%, RR 26, Pulse 88. Transferred to ED.
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| 64 | 2021-01-10 | feeling hot |
At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self ab...
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At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self abated. On day 4 developed new onset food and flower allergies which lasted until day 10. These were lip tingling, eye swelling and redness and burning.
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| 64 | 2021-01-10 | pain in extremity, tremor |
Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went...
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Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went to work and was fine (10 hour shift). She had Gammagard around 6pm and then the infusion was fine and went on as normal (a little burning at the beginning), then chills at the end (not unheard of). An hour later she went to sleep since not feeling 100%. She woke up with severe chills, headache, body aches all over, She has bad chills and is shaky. She went home and no fever. Her eyes are kind of burning. She has a call with her doctor today.
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| 64 | 2021-01-10 | pain in extremity |
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot;...
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blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-11 | tremor, pain in extremity |
10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hip...
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10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.
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| 64 | 2021-01-11 | pain in extremity |
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger...
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Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
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| 64 | 2021-01-11 | burning sensation |
I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the ...
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I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the day went on I developed slight swelling of my upper lip. The burning of my face lasted until the following day but then would come and go. The swelling of my upper lips lasted 4 days. Last Thursday 1/7/2021 my face was burning and lasted the day.
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| 64 | 2021-01-11 | feeling cold | Recipient reported heartburn sensation, chills, fatigue. |
| 64 | 2021-01-11 | pain in extremity |
left arm: pain, swelling, redness, warmth, itching: after 5 days: still a bump at injection site (b...
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left arm: pain, swelling, redness, warmth, itching: after 5 days: still a bump at injection site (but smaller than in previous days), still warmth (but less than in previous days), redness has become pinkness in a smaller area, also less itching, minor pain at touch puffy eyelids and inflammation but this may have been blepharitis which I have had in the past
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| 64 | 2021-01-12 | pain in extremity |
Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare profes...
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Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm in Jan2021 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypothyroidism. It was reported that the patient had allergies with sulfa and trimethoprim / sulfamethoxazole (BACTRIM). Concomitant medications included levothyroxine sodium (SYNTHYROID), ergocalciferol (VIT D), levocetirizine dihydrochloride (XYZAL). It was stated that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. In Jan2021, the patient experienced arm pain after 10 hours of getting the vaccine. It was also reported that nausea and lightheadedness the following day. No treatment received for the adverse events. The patient recovered from the events in Jan2021 (reported as feeling passed after 2hrs) Information on the lot/batch number has been requested.
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| 64 | 2021-01-12 | pain in extremity |
Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills,...
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Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills, low grade temp of 99.7 , skin hurt all over & generally feeling unwell. These symptoms continued until 11 pm 1/12/2021. Took Tylenol, wet to bed & woke up 1/13/2021 without symptoms.
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| 64 | 2021-01-12 | night sweats |
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to...
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Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
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| 64 | 2021-01-12 | pain in extremity |
Patient states her arm is sore and red at the injection site. It started a week after she received ...
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Patient states her arm is sore and red at the injection site. It started a week after she received the vaccine. She has been advised by her physician to ice the affected area and take Tylenol for any pain.
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| 64 | 2021-01-12 | tingling, pain in extremity, numbness |
Received Covid 19 vaccine on 1/6/2021 Left arm. Immediately had left arm pain and next day had numb...
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Received Covid 19 vaccine on 1/6/2021 Left arm. Immediately had left arm pain and next day had numbness and tingling,along with rash upper chest and neck.
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| 64 | 2021-01-12 | nerve pain, pain in extremity |
Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle ...
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Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine
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| 64 | 2021-01-12 | tremor, feeling cold |
awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu...
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awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13
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| 64 | 2021-01-12 | flushing |
felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous repor...
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felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation. Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-13 | flushing |
45 min after injection face became red and flushed and headache began, redness left in about 4 hour...
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45 min after injection face became red and flushed and headache began, redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
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| 64 | 2021-01-13 | feeling hot, facial pain, pain in extremity |
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;...
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Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
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| 64 | 2021-01-13 | feeling cold |
Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 sof...
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Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
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| 64 | 2021-01-14 | migraine |
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive saliv...
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Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
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| 64 | 2021-01-14 | pain in extremity |
First shot very sore arm; This is a spontaneous report from a contactable other healthcare professio...
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First shot very sore arm; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EH9899, expiry date not reported), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN), CKD (Chronic kidney disease), and had known allergies to bee stings. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior vaccination. Unspecified concomitant medications (reported as "lots") were taken within two weeks of vaccination. The patient previously took ibuprofen and experienced allergies. The vaccination was administered in the hospital. The patient experienced from the first shot, very sore arm on an unspecified date. Arm still sore at 60 hours. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the event reported. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event sore arm was reported as recovering.
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| 64 | 2021-01-14 | seizure, unresponsive to stimuli |
Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen leve...
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Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen level dropped to 86%, HR was 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current status
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| 64 | 2021-01-14 | weakness |
a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient als...
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a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient also developed weakness, fatigue and had chills unknown if she had fever Patient was seen by family MD after a few days of swelling
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| 64 | 2021-01-14 | feeling cold, pain in extremity |
almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in he...
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almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in her mouth, white tongue; felt a little cold; legs were sore; headache; Sore arms; severe sore throats; back ache; low grade temp/Low grade fever; coughing; body aches/ whole body was achy; it was sore to swallow; lethargy; This is a spontaneous report from a contactable consumer reporting for self. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EL1284, Expiry Apr2021, intramuscularly on 30Dec2020 02:15 (Dose 1), right arm as a single dose (age at vaccination 64 years old) for COVID-19 immunization. Medical history included allergy (usually in the fall she has allergy problems). Her age is considered high risk, works in medical profession (Surgical Tech). Concomitant medication included levocetirizine (Walgreen's generic) 5mg, tablet, by mouth, at night for allergy. The patient had the first dose of the vaccine last 30Dec(2020) and after 2 days (on 01Jan2021) she developed symptoms: Sore arms, severe sore throats, back ache/ back was sore, temperature was up / low grade temp (never high), coughing, body aches. Her back and her legs were sore. Her whole body was achy. It was "like flu-ish kinda." She also had a headache. She started getting the sore throat and headache on 01Jan2021, and she felt a little cold on 02Jan2021. On 02Jan(2021), her first temperature was 100.5 degrees Fahrenheit. She states she had everything except for the GI issues. Around 02Jan(2021) or 03Jan(2021), her symptoms were progressively getting worse. She was told to get COVID tested. There were three exposures since Christmas Eve. So, she went and got a rapid COVID test (04Jan2021) and it came back negative. They also sent out a test that day. She was also tested for Strep (04Jan2021) too because her throat was so sore. It was almost like she had like thrush along with it. She states it was almost like a thrush because she had like a white tongue (onset 03Jan2021). Her throat was so sore, but it was a different kind of sore throat compared to a sore throat she has had before. She explains where the nasopharynx was at the top, it's almost like it was sore from there. It was sore to swallow, it was "a bizarre sore throat." She clarified she noticed the "thrushy" part of her throat around 03Jan2021. The strep test ended up being negative but she believes she had thrush because she was given medication and the medication was clearing that up. However, she still had the symptoms. Because her symptoms only started a few days before, they thought she should maybe wait a couple of days and if she is not feeling any better, she should be retested (for COVID). She went back again yesterday (07Jan2021). She had another Rapid COVID test and also a flu swab and both tests came back negative. She mentions they also did another COVID test (the send out type) and she should get that back around 1pm to find out the results of that. They also did a CBC (07Jan2021) and everything was normal. Her white count was at 7. She was waiting for the 3rd COVID test result today (08Jan2021). She reported that about three days afterwards, she didn't notice the soreness in /her arm. Her throat has improved. Her fever was down to 98 degrees Fahrenheit yesterday (07Jan2021). She states she was feeling better today (08Jan2021). She commented "the lethargy, though." She emptied the dishwasher yesterday (07Jan2021) and had to sit down after emptying it. She states her symptoms have her a little worried. She recovered from the sore arms in Jan2021. The patient was recovering from the severe sore throat, back ache, low grade temp, coughing, body aches/ whole body was achy, believes she had thrush, white tongue, legs were sore, headache, and felt a little cold. The outcome of the event lethargy was not recovered. She was wondering if this was a reaction to the vaccine.
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| 64 | 2021-01-15 | one side paralysis, tremor |
shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP...
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shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP changes no rash no observed facial swelling or lip swelling but patient has dense right facial hemiparesis with preexisting asymmetry Epi pen administered, transferred to ED> solumedrol and Benadryl given IV and observation x 2 hours. home with oral prednisone x 5d dx "anaphylactoid reaction"
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| 64 | 2021-01-16 | muscle spasms |
I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entir...
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I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entire area was in pain. I could not been over without twinges of spasms. I could walk without problems--including up and downstairs (with extreme caution). On 1/16/21 I started taking Bayer for Body and Back pain and using Icy Hot on the area that hurt. I called my doctor's office for med for spasms and she said I need to see a doctor. I wanted to be compliant with her recommendations. The doctor suggested Extra Strength Tylenol every three hours.
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| 64 | 2021-01-16 | muscle spasms |
Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by...
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Saturday morning 1/16/2021, had LLQ abd pain, crampy. Has a BM and was very small. Later followed by a dime size of mucous and then later a dime size of bright red blood. No history of rectal bleeding prior. Later in the had more cramping and passed addition medium BM with blood not in stool. Noted for one day only. No idea if this is related to vaccine, but was an unusual occurrence four days after vaccine.
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| 64 | 2021-01-17 | discomfort |
After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart...
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After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.
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| 64 | 2021-01-17 | pain in extremity |
Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administra...
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Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administration. Effects lasted for 3 days despite round the clock Tylenol dosing.
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| 64 | 2021-01-17 | pain in extremity, feeling cold |
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. ...
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Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. tiredness and muscle soreness, intermittent nausea lasted for 5 days
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| 64 | 2021-01-17 | tingling |
The right side of my face (cheek) began to tingle, and the my left hand was tingling as well. This i...
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The right side of my face (cheek) began to tingle, and the my left hand was tingling as well. This is not normal for me. It feels like my cheek is going to sleep. So I've been rubbing it. As for my left hand, I've been opening and closing it.
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| 64 | 2021-01-17 | pain in extremity |
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hour...
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severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
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| 64 | 2021-01-17 | pain in extremity |
sore left arm; This is a spontaneous report from a contactable Nurse. 64-year-old female patient rec...
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sore left arm; This is a spontaneous report from a contactable Nurse. 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EKS730), intramuscular (IM) on 18Dec2020 at single dose on left upper arm once for COVID-19 immunisation. There were no medical history and concomitant medications. The patient stated that she did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it was sore. The event was considered as non-serious. The outcome of the event was not recovered.
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| 64 | 2021-01-17 | pain in extremity | very sore arm, headache, muscle aches, tiredness, chills |
| 64 | 2021-01-18 | seizure |
ER/URGENT CARE VISIT: Opening Alert charting for RETURN FROM ER (DX SEIZURE HISTORY OF). resident wa...
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ER/URGENT CARE VISIT: Opening Alert charting for RETURN FROM ER (DX SEIZURE HISTORY OF). resident was sent out to the ER @ 11:54 AM after having trouble breathing following her COVID vaccination. RN administered EPIPEN, emergency services was called and resident was sent out VIA ambulance
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| 64 | 2021-01-18 | flushing |
Employee felt flushed within 2 min of vaccine administration. Heart rate varied 56-68 Employee was...
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Employee felt flushed within 2 min of vaccine administration. Heart rate varied 56-68 Employee was observed and offered fluids and pretzels. 12:40- Bp 138/65, HR 62 100 % o2 sat. 14:00 156/80 68 100% on RA Lungs CTABL rrr no murmer. Employee was discharged to home. 1/15 Called employee for follow up and employee reported that she experienced intermittent chest pressure x approx 2 days at home and elevated BP which resolved on 1/1/21 had taken losartan 25 in the morning, thend again after COVID vaccine and again before bed. Employee was referred to contact PMD to assist in determining if secondary dose is okay to receive or if she will need cardiac eval. Employeee was referred to Oc health clinic, examined and discharged with recommendation to double losartan before next vaccine and talk to PMD before second dose of covid vaccine. Employee was also provided with the PFIZER number to report this to Pfizer.
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| 64 | 2021-01-18 | feeling hot |
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, esp...
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Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
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| 64 | 2021-01-18 | night sweats |
She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COV...
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She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
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| 64 | 2021-01-18 | pain in extremity | Sore arm the next morning , not bad Almost exactly 24 hrs later, fever, chills and achiness. |
| 64 | 2021-01-18 | pain in extremity |
Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable c...
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Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on 08Jan2021, temperature of 99.2 and started feeling achy on 09Jan2021. Event details: The patient received the first dose of the vaccine yesterday (08Jan2021). Yesterday night, she started with a sore arm which she expected then this afternoon (09Jan2021) she started to experience feeling achy and when she checked her temperature it was 99.2, for the sore arm last night and this morning she took Ibuprofen for treatment. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 64 | 2021-01-18 | pain in extremity |
With my first injection I did have arm pain; This is a Follow-up spontaneous report from a contactab...
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With my first injection I did have arm pain; This is a Follow-up spontaneous report from a contactable Other healthcare professional. A 64-year-old female patient received BNT162B2 (Pfizer BioNTech, lot number: EH9899) first dose on 18Dec2020 07:30 AM on left arm at single dose for COVID-19 immunization. Medical history included Elevated Blood Pressure and Atrial Septal Defect repair in 2008. No Known allergies. Concomitant medications in two weeks included Olmesartan Medox/HCTZ40-12.5 MG TAB. Patient is not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. With her first injection she did have arm pain, but otherwise resumed normal activity. No treatment for the event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was recovering.
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| 64 | 2021-01-19 | pain in extremity, hot flush | FEVERISH; HOT FLASHES; MUSCLE ACHES; MILD HEADACHE; SORE ARM. TOOK ADVIL 600MG 2X DAILY |
| 64 | 2021-01-19 | migraine, weakness |
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ...
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Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
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| 64 | 2021-01-19 | tremor, tenderness, pain in extremity |
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore...
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On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
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| 64 | 2021-01-19 | tremor |
Pt passed out & shaking (possible seizure) shortly after injection. 911 called. Pt conscious after ...
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Pt passed out & shaking (possible seizure) shortly after injection. 911 called. Pt conscious after 1-2 minutes. Declined transport to ER. Monitored by RN and pharmacist for 45 min. Pt's husband drove her home when status returned to normal
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| 64 | 2021-01-19 | weakness |
Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in ar...
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Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in arms and legs Exam on 19 Jan 2021 revealed hyperreflexia and slightly spastic gait concerning for transverse meylitis
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| 64 | 2021-01-20 | numbness |
Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue,...
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Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue, and heel numbness. The heel numbness began the night of the injection. Patient said half of their left foot and heel felt numb. Patient states that the numbness has fully resolved by the next morning, 1.21.2021. Patient encouraged to call PCP with worrisome or bothersome problems. Patient encouraged to call back with any new changes or questions about the vaccine.
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| 64 | 2021-01-20 | tremor, feeling cold | low grade fever, chills, aches, sensitivity to light, shakes |
| 64 | 2021-01-21 | discomfort | R upper lip heaviness/swelling with small ulcer 30 minutes after vaccine administration |
| 64 | 2021-01-22 | weakness | Chills, fever, headache, muscle pain, fatigue, weakness |
| 64 | 2021-01-24 | numbness, sensory loss |
About 3 hours before bedtime she started having decreased sensation of her left hand. Involved her ...
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About 3 hours before bedtime she started having decreased sensation of her left hand. Involved her entire left hand from the wrist down. By morning, her numbness had resolved entirely.
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| 64 | 2021-01-24 | pain in extremity |
Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm ...
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Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm 1.5 days, no other effects. Clean injection into deltoid muscle bulk. Second shot, injection shot extremely high above main muscle bulk of the deltoid into area of supraspinatus tendon one finger below acromial shelf. First shot, two sensations: initial puncture then injection. Shot 2 one huge painful bump met with resistance in my tissue. Also Shot 2 not one response except mild fatigue still today, but no pain in upper arm unless I pressed specifically into injection site itself. WAS THIS VARIATION IN INJECTION SITE ACCEPTABLE? WAS IT OK TO DO INJECTION SO VERY HIGH UP? Secondly, had a wonderful, professional nurse, but I question the practice of retrieving a dose for me that comprised of doses left over at bottom(s) of other vial(s). We had a new vial in the office where I was, but she left and came back with a syringe already full, saying that it was important to use up every drop. At first I agreed, but now I question this practice and just want to make sure I don't need to come back for another second dose. Are there no substrates that would settle out of the solution as the vial gets depleted of everything except only a bit of fluid left in it? Is retrieving every last drop from each vial and putting them together to make a dose acceptable practice? if not, from the Pfizer standpoint, then I should get another dose? I am a pediatric physical therapists working within 1-2 feet a children's faces at all times and transmissibility is a real issue both ways in my job. I truly do not want o become a Covid victim. please let me know if both the injection site and the method b y which my dose was put together is acceptable in the eyes of Pfizer. Thank you.
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| 64 | 2021-01-24 | numbness | Numbness down my arm, into my hand and two fingers. Pain, limited movement. |
| 64 | 2021-01-24 | weakness |
bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time)...
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bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
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| 64 | 2021-01-24 | pain in extremity |
forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most...
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forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-01-25 | burning sensation, tingling |
c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 7...
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c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 77-18-120/7 ; full ROM noted-provided ginger ale 1016 78-18-112/61-97% RA R arm continues with "hot wire on 1/2 of Right forearm, continues feeling dizzy but not worse, using Zailo patch for pain control x 2 weeks; at 10:22, 74-18-110/59-98% A&Ox3, Right ear fullness/dizziness improving ; at 10:32 71-18-119/63-99% reports decreased ear fullness dizziness, more normal feeling on RFA, full ROM; @ 10:41, 71-18-102/56-98% denies dizziness or arm burning, ear fullness gone, no n/v
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| 64 | 2021-01-26 | unresponsive to stimuli |
Became unresponsive and was unarousable to sternal rub. A code blue was called and she woke up. Her...
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Became unresponsive and was unarousable to sternal rub. A code blue was called and she woke up. Her BP was elevated (176/120) and HR 45, o2 sat 100%, RR 16. About 15 minutes later, she had a repeat syncopal episode and was transferred to the emergency dept
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| 64 | 2021-01-26 | tingling |
Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and l...
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Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
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| 64 | 2021-01-26 | feeling cold |
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d...
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Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
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| 64 | 2021-01-27 | pain in extremity | Sore arm, Bloating, gas and diarrhea |
| 64 | 2021-01-27 | pain in extremity |
abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore;...
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abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
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| 64 | 2021-01-28 | weakness |
Feeling weak; This is a spontaneous report from a contactable other healthcare professional (patient...
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Feeling weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 13Jan2021 (14:45) at single dose for Covid-19 immunization. The patient's medical history included anxiety and known allergy to Grapefruit. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling weak on 16Jan2021 (23:00). There was no treatment received for the adverse event. The patient has been tested for COVID-19 post vaccination on 16Jan2021with Unknown result. The outcome of event was recovering.
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| 64 | 2021-01-28 | flushing, feeling hot |
Patient reports receiving Pfizer dose 2 at 0840 was self-observing for adverse reactions in waiting ...
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Patient reports receiving Pfizer dose 2 at 0840 was self-observing for adverse reactions in waiting area when at 0855 she developed a very hot feeling and became flushed. Patient notified vaccination staff. Patient denies any adverse reaction to Pfizer dose 1. 0855 BP 158/106, HR 109 SPO2 96%. Afebrile. Dr. evaluated Patient. 0909 Patient reporting flushed feeling, very hot and vision changes. Patient transferred to the Emergency Room for further evaluation. No medication administered.
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| 64 | 2021-01-28 | pain in extremity |
The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours l...
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The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours later your feeling much better. Took Tylenol and also Ibuprofen and stayed hydrated. Also had arm soreness, which she had with 1st vaccine as well.
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| 64 | 2021-01-29 | feeling hot |
COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20...
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COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care. Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER. She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur. IMPRESSION: Anaphylaxis Anxiety attack
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| 64 | 2021-01-29 | numbness |
Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their ...
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Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their 2nd dose of the Pfizer Covid-19 vaccine (lot EL3247) on 1/21 at LMC. On 1/22, the patient reported with tachycardia, hypotension and arm numbness. Dr was concerned that the injection was given too high on the patient's arm and potentially into the shoulder joint. Patient was directed to the LMC ED for treatment. The patient was given fluids and was discharged home. The ED provider did not believe the vaccine was given into the joint.
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| 64 | 2021-01-29 | hypersensitivity of all senses | skull severely hyperesthetic..could not lie on my back and put head on pillow |
| 64 | 2021-01-30 | pain in extremity |
Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like...
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Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.
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| 64 | 2021-01-31 | pain in extremity |
Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am tha...
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Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.
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| 64 | 2021-01-31 | pain in extremity |
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a sponta...
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Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 64 | 2021-01-31 | tremor, pain in extremity |
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever ...
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Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
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| 64 | 2021-01-31 | pain in extremity |
Sore arm after the first dose of COVID Vaccine; This is a spontaneous report from a contactable othe...
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Sore arm after the first dose of COVID Vaccine; This is a spontaneous report from a contactable other health professional (Patient). A 64-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK57530), via an unspecified route of administration on 17Dec2020 09:10 at left arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient experienced sore arm after the first dose of covid vaccine on 17Dec2020. She received the first dose on 17Dec2020 and tolerated pretty well. She only had a sore arm. It started the same day on 17Dec2020, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. the outcome of the event was recovered in Dec2020. Reporter considered the event Sore arm after the first dose of COVID Vaccine was not serious. Event did not result in Emergency Room/Physician Office. She also stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.
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| 64 | 2021-01-31 | tingling |
Within a half hour of receiving vaccine, I started feeling prickly from my torso down. When I got h...
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Within a half hour of receiving vaccine, I started feeling prickly from my torso down. When I got home I realized that I had felt this before and immediately removed my scrubs. I had raised red areas on my bilateral thighs and torso. I took Benadryl po.
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| 64 | 2021-02-01 | burning sensation |
Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported. ...
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Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported. About 2 hours after patient returned home, patient's outside of her mouth started to burn. She continued to wait to see if it resolved and when it didn't, she returned to vaccine clinic. Nurse practitioner at vaccine clinic administered 25mg PO Benadryl and had her wait another hour. Patient was able to be discharged but continued to have itchiness and burning. She was seen by her PCP the next day and was given a steroid shot and instructed to continue Benadryl every 6 hours.
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| 64 | 2021-02-01 | pain in extremity, weakness, tremor |
Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8 hours. Shaking uncontrollably, aches and pains, very weak, exhausted, nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water. Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.
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| 64 | 2021-02-01 | pain in extremity |
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N...
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Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-02-01 | feeling hot |
broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; fac...
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broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; face was really swollen and red; skin was blotchy; This is a spontaneous report from a contactable consumer reported for herself. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route at right arm on 16Jan2021 about 11:00 for vaccination against Covid. No additional vaccines administered on same date of the Pfizer Suspect. Medical history included anxiety, high blood pressure, and ongoing physical urticaria (with no investigation assessment) where if she gets warm her arms itch and she breaks out in a little bit of hives, but never to this extent. Concomitant drugs included lisinopril at 20mg, 1 tablet by mouth once daily for high blood pressure, and sertraline at 50mg, 1 tablet by mouth once daily for anxiety, both ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as "none". No other vaccines given the same day and none 4 weeks prior. No history of problems with vaccines in past. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine was "none". No events following prior vaccinations. Family medical history relevant to the event was reported as "none". Patient reported an adverse event/side effect to the Covid vaccine, and was not sure if she should go ahead with the second dose or not. Patient received the vaccine on 16Jan2021 (reported as Saturday as of 18Jan2021) about 11am and at 5pm she started getting a warm feeling and changed to cooler clothing. Patient started itching and then broke out in hives on her face, arms, and chest. Patient used a cool cloth to face to cool off and sat under the fan. Her daughter got her some diphenhydramine hydrochloride (BENADRYL) within that 15minutes and about 20-30 minutes of taking the diphenhydramine hydrochloride it was calming down. Patient only took 1 diphenhydramine hydrochloride to help and that took care of it. This was the only occurrence. Her face was really swollen and red, she looked like she was sun burnt, skin was blotchy, but she didn't have any trouble with breathing or heart palpitations. The event onset date was 16Jan2021. The events did not require a visit to Emergency Room/ Physician Office. No relevant tests performed. Outcome of the events was resolving.
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| 64 | 2021-02-01 | pain in extremity, burning sensation, tingling |
tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; ...
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tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; headache; myalgias; This is a spontaneous report from a contactable physician. A 64-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included mechanical valve, atrial fibrillation. No known allergies. There was concomitant medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 1-3 (13Jan2021), the patient had arm pain, headache, myalgias, then day 4 felt better and on day 5-7 (17Jan2021) developed tingling and severe burning in her legs and arms, that gradually improved to only included tingling in the feet at this date 7 day after injection. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
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| 64 | 2021-02-02 | flushing |
Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I too...
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Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I took 2 loratidine tablets and symptoms slowly subsided over the next 50 min. The next day had chills and nausea for 8-10 hr. The nausea lasted another 3-4 days.
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| 64 | 2021-02-03 | pain in extremity |
Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came ...
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Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; it hit the bone/ it was given in bone; it hit the bone and after the nurse pulled back the needle, some of the fluid dripped down my arm; "it hit the bone"/When it was given it felt like cracking in her bone; patient's arm was sore and bruised; This is a spontaneous report from a contactable nurse. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248), via an unspecified route of administration in the left arm, on 16Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. The patient stated that during vaccination last Saturday(16Jan2021), "it hit the bone". The nurse pulled back the needle and after that some of the fluid dripped down her arm. Then it was further reported that it was given in bone and "all of the vaccine came out and dripped down to her wrist". Hence, they wanted to know if patient should get it re-administered or get another half dose. Patient's arm was sore and bruised, the first day was so sore but it was getting better. When it was given it felt like cracking in her bone and she thought the needle broke. After the nurse withdrew the needle, she was told it was not broken but said the needle must have gone to the bone. The outcome of event "patient's arm was sore and bruised" was recovering whereas the outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 64 | 2021-02-03 | discomfort, weakness |
Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a...
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Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a day and returned for another day and went away on its own. I had inside body chills, felt weak and tired and had a little sinus pressure but no fever which lasted for about 2 or 3 days. I took aspirin to help with the discomfort and today I still have just a little nagging headache that comes and goes but all other symptoms has since subsided. The injection site swole and developed a knot which stayed about a week and is still a little red.
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| 64 | 2021-02-03 | feeling hot |
at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot,...
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at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot, dizzy, and lightheaded with vasovagal like symptoms. Pt moved to reclined position, and reported immediate relief. Vitals taken at 3:35: BP 132/90, 66 HR. Denies other s/s allergic reaction. Clt sat up 8 min later, states symptoms resolved. Clt completed Vaccine observation period, ambulated self to bathroom and left site at 3:46 pm.
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| 64 | 2021-02-03 | weakness |
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th...
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more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
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| 64 | 2021-02-04 | pain in extremity |
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti...
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Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
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| 64 | 2021-02-04 | pain in extremity | Significant joint pain - neck, arms, hands and legs |
| 64 | 2021-02-04 | weakness |
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes...
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Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
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| 64 | 2021-02-05 | facial pain |
Pain in L forehead and face, superficial. Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely...
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Pain in L forehead and face, superficial. Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely shingles reactivation (have had once before). Prescribed valcyclovir.
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| 64 | 2021-02-06 | pain in extremity, burning sensation |
I made a mistake my vaccine was jan 16th not 15th. That evening i was Very tired got a sore arm an...
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I made a mistake my vaccine was jan 16th not 15th. That evening i was Very tired got a sore arm and fever blister break out on my upper lip 10 hrs after vaccine. Next day Sharp pain in my right big toe joint on day 2, then day 3 burning and stinging pain above my left knee last 6 or 7 hours and also a very sharp pain between my toes like a splinter on the same side as knee pain. I Have felt tired and bad brain fog since vaccine, just have felt really off. Now i am scared to get the second dose. My father had a rare neurological disease after being exposed to chemicals in the army. I then got a cough and had some off color mucous for several days. I am thinking of waiting to get second does, please advise.
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| 64 | 2021-02-07 | pain in extremity |
Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, te...
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Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, temp came down. The next day, she experienced chills, joint pain, body ache. The next day, still had symptoms but not as bad. She is getting back to normal but is still having some mild symptoms.
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| 64 | 2021-02-08 | difficulty speaking |
37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal...
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37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal syncope. Started sweating, and I lost my vision, then must have fallen on the floor. When I came to, felt very headachy and nauseous. went to urgent care - they ordered an abdominal scan for 2/8/21 but scan did not reveal the cause of the pain. 8 hours later on 2/5/21, started feeling asthma like symptoms. Throat felt tight, voice became hoarse, kept having to cough because airway was starting to feel thickened. went to ER, they took vitals and told me that i wasn't having an allergic reaction because my symptoms were outside the time frame for an allergic reaction. After 3 hours there, they sent me home. Next morning felt like I was having heart palpitations. that feeling eventually went away if I walked around. But the following two mornings, I had the same feeling.
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| 64 | 2021-02-08 | tingling |
Immediate paresthesia's of the lips that last around 48 hours. Headache with onset at 24 hours follo...
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Immediate paresthesia's of the lips that last around 48 hours. Headache with onset at 24 hours following injection and lasting 3 days.
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| 64 | 2021-02-08 | migraine, tingling |
Immediately following injection the patient developed paresthesia's of the lips. Six days later he d...
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Immediately following injection the patient developed paresthesia's of the lips. Six days later he developed symmetrical paresthesia's of the lower extremities that have progressed up the legs to the knees bilaterally. Additional symptoms include brain fog, fatigue and migraines with increasing frequency. Symptoms have continued to progress now one month later. No treatment. Pending neurology evaluation.
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| 64 | 2021-02-08 | bell's palsy |
January 30, 2021, began experiencing Bell's Palsy type symptoms. Went to ER on February 1, 2021 whe...
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January 30, 2021, began experiencing Bell's Palsy type symptoms. Went to ER on February 1, 2021 where I was diagnosed and prescribed Prednisone, Valacyclovir and Artificial tears.
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| 64 | 2021-02-09 | pain in extremity, numbness |
The outside of my left started to tingle and went all the way down unto my hand and fingers, the out...
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The outside of my left started to tingle and went all the way down unto my hand and fingers, the outside of my palm from my little finger and up to about 2" above my wrist. After a couple of days only my hand felt and fingers were still numb. That lasted about a week and then the last week until the day that I got my 2nd injection (Feb. 5) only my little finger felt like that. I have that sensation in my hand again but it is very weak and it comes and goes. I have migraines and sometimes I have that feeling in my arm and hand.
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| 64 | 2021-02-10 | weakness |
Left side of neck stiff with ache, left side of mouth (teeth) ached up to behind the ear. Headache,...
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Left side of neck stiff with ache, left side of mouth (teeth) ached up to behind the ear. Headache, body ache, fatigue, low energy, Ibuprofen 400 mg every 6 hours
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| 64 | 2021-02-14 | flushing |
25 minutes after receiving vaccine: flushing, slight throat swelling;Vitals were normal Resolved wi...
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25 minutes after receiving vaccine: flushing, slight throat swelling;Vitals were normal Resolved within 1 hour
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| 64 | 2021-02-14 | tremor |
Pt. c/o nausea and being shaky. Pt was taken to observation room for assessment. Pt stated that la...
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Pt. c/o nausea and being shaky. Pt was taken to observation room for assessment. Pt stated that last well visit was in November which Doctor Lower doses of some meds. Pt ate some peanut cracker and had some water and started feeling better. BP 160/90, Pt was escorted to her car and SPO2 98%. Pt texted my Supervisor stating she made home just fine.
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| 64 | 2021-02-14 | pain in extremity |
extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 an...
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extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 and admitted through ER on 2/10/21. Inpatient for 3 days. IV antibiotic DC'd when blood cultures negative. Ultrasound left arm negative for DVT. Seen by Infectious Disease and he felt it was due to covid vaccine reaction. Started on steroid
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| 64 | 2021-02-14 | facial pain, weakness |
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, ...
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fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
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| 64 | 2021-02-15 | numbness |
After receiving the COVID vaccine at 12:43 patient stated that she couldn't breath and her arms & l...
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After receiving the COVID vaccine at 12:43 patient stated that she couldn't breath and her arms & legs were numb at 1:10 pm. Patient received an Epinephrine pen at 1:12 pm and the paramedics were contacted.
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| 64 | 2021-02-15 | pain in extremity | On 2/7 at 01:00, woke up with headache, chills, fever, nausea and increased arm pain. |
| 64 | 2021-02-16 | weakness |
I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomi...
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I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomiting within a couple hours. Around noontime I vomited twice more. I got worse, could not walk around. I felt extremely sick but felt better when I lay down in bed. I was not able to go to work, had to cancel the substitute teaching assignment I had taken. I did sleep some. No doctor called me back except my daughter texted with me. She is an intern, said she wished she could be with me. My neighbor brought some Pedialyte. This morning, the next day, I am still weak and nauseous, but it is less. At the end of the day yesterday, I did eat a little rice with carrots. And I just ate a little plain oatmeal with raisins and salt. I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated. Maybe a long time ago.
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| 64 | 2021-02-16 | weakness |
patient was vaccinated at 0801. After 15 minutes patient started feeling light headed and weak. Vita...
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patient was vaccinated at 0801. After 15 minutes patient started feeling light headed and weak. Vital taken. patient was monitored until 0842 with little improvement in symptoms and pulse was low. Patient was transferred to urgent care , and checked in for further evaluation,
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| 64 | 2021-02-18 | tingling |
3 weeks after the first dose I developed sudden onset severe myalgias in the cervical neck, shoulde...
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3 weeks after the first dose I developed sudden onset severe myalgias in the cervical neck, shoulders, deltoid, gluteal, and hamstring muscles. These were my only symptoms at onset. No fever, No Sand S of infection, etc. VItals were stable. Lab work, including complete chemistries CBCD, ESR, and CRP, was all WNL. However, 5 days after onset with no improvement in the myalgias, my creatinine kinase (CK)was 402 ( normal up to 175). Over a period of an additional 8 days, the myalgias have gradually decreased, and my current CK level, as of 2/17, is 275. My physician is terming it autoimmune myositis and believes it is from the vaccine. I have also had some mild tingling in my hands and feet intermittently that started soon after the myalgias. No true neurological deficits. No other symptoms. I am the patient but also a docotrally prepared nurse practitioner, so that is why this patient report is in medical terminology.
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| 64 | 2021-02-19 | tenderness, hot flush |
Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simulta...
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Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simultaneously I felt my heart racing and feeling flush. I raised my hand to alert attendant. Took pulse and it was very high. They called EMT. Upon connecting me to heart monitor is was erratic, Very high blood pressure. When they touched chest it hurt more. They said I was bright red. They transported me via residue to Hospital. Residual mild rash under skin for several days. Had severe headache for 14 hours.
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| 64 | 2021-02-21 | tenderness |
Patient initially described superficial itiching of hands. Upon observation, was scratching all over...
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Patient initially described superficial itiching of hands. Upon observation, was scratching all over her torso and arms as well as neck. Benadryl 50 mg provided with improvement in superficial itching but endorsed internal abdominal itching and continues to touch her throat.
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| 64 | 2021-02-21 | difficulty speaking | hoarse voise s/p 2nd vaccine 20 mins after vaccine |
| 64 | 2021-02-22 | hot flush |
C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluate...
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C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluated P 94 148/99. Ok to walk with husband as nd left for home w husband 12:26 pm.
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| 64 | 2021-02-23 | tingling |
Patient complains of tingling of the fingertips on her left hand. Denies weakness, numbness, dizzin...
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Patient complains of tingling of the fingertips on her left hand. Denies weakness, numbness, dizziness, headache, sob and chest pain. Denies lip/throat tingling/swelling.
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| 64 | 2021-02-23 | weakness |
Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on sk...
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Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on skin lesions. Headache, weak, overall feeling sick. I had Covid over thanksgiving 2020. I still had antibodies when I got my Covid vaccine.
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| 64 | 2021-02-23 | pain in extremity |
arm was very black and blue where the shot was administered and way around it/severe black and blue ...
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arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.
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| 64 | 2021-02-24 | pain in extremity |
Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS...
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Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS, cleared.
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| 64 | 2021-02-25 | pain in extremity | Normal arm soreness, very achy, tiredness |
| 64 | 2021-02-25 | difficulty speaking |
Patient started having tingling in her lips 5 days after the injection, then she began having a sore...
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Patient started having tingling in her lips 5 days after the injection, then she began having a sore throat, she started having a hoarse voice and she felt very tired. 911 was called. In route they were transporting patient she was hypertensive had normal heart rate they gave her Benadryl 50 mg orally and then epinephrine 0.3 mg IM which did not help patient at all.
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| 64 | 2021-02-26 | flushing, difficulty speaking |
Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to it...
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Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to itch a little. A little itching around eyes. About an hour after, felt tightness in my throat and neck, glands felt swollen. Became slightly hoarse, had to clear my throat often. Felt a little like asthma attack. Have had similar reaction when eating seafood
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| 64 | 2021-02-27 | pain in extremity |
Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed ...
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Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed limiting mobility. In the past 7 days patient has progressively declined in from independent to requiring assistance with walking. Pain and limited mobility in legs
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| 64 | 2021-02-27 | pain in extremity |
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ...
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Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
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| 64 | 2021-02-27 | seizure like phenomena, numbness |
With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like e...
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With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating. Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.
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| 64 | 2021-02-27 | tingling | tinkling in fingertips |
| 64 | 2021-02-28 | pain in extremity |
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spo...
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Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.
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| 64 | 2021-02-28 | pain in extremity |
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next ...
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Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
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| 64 | 2021-02-28 | numbness, burning sensation |
Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS....
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Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS. Have not been on any medications for the CRPS for over 2 years with minimal to no exacerbation of CRPS events. I have a long history of flair ups with insults to my body (e.g. post accident, post surgery, extensive dental work). The numbness and burning started to return within 2 hours of injection to the right side of my face and my right hand. Then these symptoms started to return to other locations on my body throughout the week (lower back, left knee and right ankle). The only site that has subsided 1 week post injection is my right hand though all symptoms have not resolved there either. The burning in my lower back got so bad on Thursday that I had issues sitting and scheduled an appointment with Dr. for Monday 3/1/21. Telehealth visit with Dr. this AM and returning to medication to treat CRPS/RSD till episode resolved.
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| 64 | 2021-02-28 | weakness |
Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days ...
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Within 30-45 minutes after injection, I started to feel a tingling around my jaw area. Then 3 days later I have had several episodes of dizziness, weakness and nausea. This has continued until today (4 days) along with aching across sholders and behind eyes.
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| 64 | 2021-03-01 | tremor, feeling hot |
7:00 PM - 2 hours after the vaccination I felt very hot. I was not running a fever. I started shakin...
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7:00 PM - 2 hours after the vaccination I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction 10:00 PM Left the clinic. Went home and slept. I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am unsure of getting the second dose.
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| 64 | 2021-03-01 | flushing |
Patient received vaccine at 1008. At 1038 patient presenting with c/o "throat tightness" and flushin...
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Patient received vaccine at 1008. At 1038 patient presenting with c/o "throat tightness" and flushing of the skin. Pt has history of anaphylaxis with shellfish, contrast, and allergy shots. Ems notified in house. 1047: VSS: B/P 130/77, HR 77, SaO2 95-97% on RA. Appears in NAD, Skin pink, warm and dry. Patient given water and able to swallow without issues. Observed patient for 45 minutes and symptoms resolved patient cleared by EMS and discharged home.
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| 64 | 2021-03-01 | pain in extremity |
upon receiving the vaccination I had a stinging pain and I bleed down my arm. The administer wiped i...
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upon receiving the vaccination I had a stinging pain and I bleed down my arm. The administer wiped it with a cotton ball. The person who administered the vaccine did not pull out or start over again. I believe she hit a vein. Now i have a scar on my arm. it is still painful and since it may not have been on a muscle I am not even sure I am vaccinated.
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| 64 | 2021-03-02 | weakness |
Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - diff...
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Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination. Lasted a little over 3 hours. Profound fatigue the next day.
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| 64 | 2021-03-02 | pain in extremity |
sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillar...
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sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillary lymph nodes; This is a spontaneous report from a contactable healthcare professional. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 64 years, via an unspecified route of administration on the left arm on 28Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included allergies, MVP (Mitral valve prolapse), HBP (High blood pressure) and thalassemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 on 07Jan2021 (age at vaccination: 64 years), lot number: Ek9231 and experienced mild headache tiredness bruised arm not at injection site. On 29Jan2021, the patient experienced mild headache, slight fever and swollen painful axillary lymph nodes. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, COVID test: negative on 15May2020 and nasal swab: negative on 01Oct2020. The outcome of the events was not recovered.
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| 64 | 2021-03-03 | pain in extremity, tingling |
Tightness in left bicep (frontnot where shot administered) and forearm and tingling in hand (left ...
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Tightness in left bicep (frontnot where shot administered) and forearm and tingling in hand (left side where shot administered. Tightness has dissipated somewhat, but tingling in hand continues to be present Sore throat right after administration Extremely sore arm for 2 days after administration
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| 64 | 2021-03-05 | pain in extremity, numbness |
Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be o...
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Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be observed for 30 minutes. At approximately 11:40 am, patient c/o GI-upset; continued to observe. At approximately 11:50 am patient c/o left arm heaviness and numbness to fingers and pain up and down left arm. Paramedics were radioed at 11:53 am and arrived at 11:55 am to assess patient. Patient left with daughter in stable condition at 12:15 pm.
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| 64 | 2021-03-06 | feeling hot |
Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep...
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Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep attacks, yet couldnt sleep, head just nodded up and down. felt very hot suddenly from the sides of the throat down straight and under both breast, felt as if I was being squeezed to death. chest felt very heavy. yet not gasping , or breathing fast. Im a respiratory therapist disabled now. I took bp was 120/80, o2 sat was 97, heart rate was 16, pulse 83. I could not lie down as felt as if being smothered. had to lie down but elevated very high. felt as if throat and chest were hot, but i did not get up to see if red, as i was having severe brain fog and oh so sleepy, yet felt so wired on friday evening March 5,2021 when I had the shot. I was awake, this tiredness and heaviness didnt happen until 1pm the next day. Saturday evening, I took o.1 ativan , thinking it was maybe anxiety as the brain for cleared after 3 hours, the chest heaviness got better, but still persisted over to sunday, march 7, but throat feeling closed in dissipated after 3 hours on saturday. 3/6. Sunday still unable to lie down as chest still felt heavy, bp 140/80 which was elevated. pulse elevated, respirations were 20. however all side effects seemed to be subsiding
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| 64 | 2021-03-06 | flushing, feeling hot, feeling cold |
Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling wel...
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Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling well. About 10 to15 minutes later she began to complain to her son that her head felt "bloated", her eyes felt heavy and her head felt hot. The nurse removed the patient to the nurses station and took her vital signs, then notified the clinical lead PN. The patient Initial vital signs taken at 13:15 were BP 157/85 P 78 , O2 sat 99%,. R 18. Denies Shortness of breath, difficulty breathing or swallowing. No skin color changes noted. No rash or pruritis. Denies chest pain, pressure or palpitations. Consumed a bottle of water without difficulty. About 20 minutes after the vaccine was received she began to feel faint, but did not feel as though she was "going to pass out" . VS remained stable; BP 157/85/P78.O2sat 99% She continued to c/o head fullness, but now was reporting feeling chills, and flushing . Son administered an extra strength Tylenol at 13:10. Nurse acted as interpreter as well as her son. Paramedics were called initially at 12:56 and again at 13:21 Patient was able to get up and walk to the bathroom with attendants , voided under observation and return to her chair without complaints of instability or dizziness. Paramedics arrived at 13:45. Vs were noted to be 160/90 , pulse 75, O2sat 99% Patient continued to complain of head and eye fullness and vertigo( Paramedic looked like her was swaying). Patient appeared stable ,in no acute distress when she was escorted out of the building ambulance by paramedics at 13:55 to be taken to a Hospital for evaluation.
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| 64 | 2021-03-06 | tremor, slurring |
This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Wi...
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This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Within 5 minutes after vaccination, she complained of a racing heart, a new onset tremor of hands and head, and slurred/stuttering speech. She denied chest pain, shortness of breath or itching. No facial droop or one-sided weakness was observed. The patient had a history of hypertension and history of an adverse reaction to albuterol in November 2020. The patient described being nervous to get the vaccine due to her previous reaction to alberterol which had the similar effects as today's. The patient's new tremor worsened, and speech became more slurred and stuttered while we observed her. The patient denied any pain and described a similar event that caused her to be hospitalized for a week with no definitive diagnosis. Her primary care doctor had cleared her to get the vaccine. Her Vitals were as follows: BP 160/90. HR 65, RR 20. Heart sounds were regular with occasional PVC's. Lung sounds were clear No visible rash on neck, trunk or injection site. Capillary refill was normal. Mild edema in both lower extremities. No swelling of the lips. No visible droop in facial muscles. Patient was tearful and struggled to speak. She repeatedly said she was tired. She reported nausea. EMT was called and found similar vitals and O2 saturation at 100% on room air by pulse ox. O2 via nasal canula was begun. Rhythm strip showed NSR. Patient refused transport to the hospital for further evaluation. She was informed of a possible Transient Ischemic Attack (TIA) could be occurring which could need a blood thinner and further work up. Patient was tearful saying her previous hospitalization was traumatic and did not want to return. EMS offered her transport to another hospital facility via private vehicle, and she refused. We offered to contact her primary care doctor and she also refused. She was concerned about the cost of a hospital stay if she signed out AMA. EMS left the facility and offered to return if the patient changed her mind. The patient's symptoms had not resolved by 4:30pm. The patient's son, by phone, confirmed she would be monitored until 5pm. She was driven home by one of our staffers. The next day, the patient told our staffer that she felt well. She said it took about 7 hours for her speech to return. She said her head, stomach and body felt better in the morning. She said she going to see an allergist as her doctor recommended. Our presumed diagnosis was a TIA related to uncontrolled HTN with anxiety.
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| 64 | 2021-03-06 | flushing, feeling hot |
Within 10-15 minutes of receiving the shot, my face and ears became very flushed and hot; I felt as ...
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Within 10-15 minutes of receiving the shot, my face and ears became very flushed and hot; I felt as if I had a large dose of a Medrol Dose-pak/steroid. I did not have any difficulty breathing, nor did I feel my throat constricting or other symptoms of anaphylaxsis. Since my symptoms were relatively minor, I did not alert the volunteers at the vaccine site that I needed to see the paramedic on duty. The only concession I made to my symptoms was that I allowed my adult daughter, who came with me for a vaccine, to drive us home. My symptoms subsided within 30 minutes and have been gone ever since.
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| 64 | 2021-03-07 | weakness | Fever, weakness, nsusea, dizziness |
| 64 | 2021-03-07 | weakness |
Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe m...
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Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe muscle pains, extraordinary fatigue, diarrhea and nausea, swelling feet, weakness
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| 64 | 2021-03-07 | weakness, pain in extremity |
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u...
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My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
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| 64 | 2021-03-07 | tremor |
On 2/15 At 9-10pm she noticed her entire body shaking as ?if she was having a seizure?. She states t...
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On 2/15 At 9-10pm she noticed her entire body shaking as ?if she was having a seizure?. She states this lasted for about 10 seconds. No report of previous seizure disorder. No incontinence, shaking stopped. On Friday night feb 19th, she noted itching in her left eye, eye was swollen , almost shut and then the right eye also became swollen almost shut. Face was very puffy. She then placed cold compress an eyes and took Benadryl. Second dose was not administered today 03/08.
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| 64 | 2021-03-07 | flushing | flushing, dizziness, tachycardia |
| 64 | 2021-03-08 | tingling |
After receiving her vaccine client stated that she felt light headed, has tingling in both hands and...
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After receiving her vaccine client stated that she felt light headed, has tingling in both hands and feet.
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| 64 | 2021-03-08 | weakness |
Evening of 3/8/21 severe dizziness, nausea, vomiting, weakness: lasted several hours then gradually ...
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Evening of 3/8/21 severe dizziness, nausea, vomiting, weakness: lasted several hours then gradually improved overnight
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| 64 | 2021-03-08 | numbness |
Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like pas...
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Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like passing out. Lasted for about 3 minutes.
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| 64 | 2021-03-08 | muscle spasms |
RASH STARTED @ 1.5 DAYS LATER...STARTED ON CHART ALL ACROSS/GOT WORSE AS DAY PROGRESSED ALL OVER BOD...
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RASH STARTED @ 1.5 DAYS LATER...STARTED ON CHART ALL ACROSS/GOT WORSE AS DAY PROGRESSED ALL OVER BODY.. NOT ON LEGS PAST KNEE AND ONLY ON INSIDE OF BOTH ARMS...OTHERWISE ALL OVER BODY NOT FACE EITHER HOT AND ITCHY.. FRIDAY WENT TO URGENT CARE THEY GAVE ME STEROID METH PAK 4 MG GOT WORSE OVER WEEKEND AND WENT TO EMERGENCY ROOM MONDAY MORNING 3/8 AT @ 6 AM I WAS GETTING CHEST SPASMS IN FRONT CHEST AND BACK/MY RASH WAS THE WORST ON CHEST. HOSPITAL CHECKED OUT HEART...ALL GOOD/PLATELETS ALL GOOD I FORGOT TO MENTION EARLIER THAT I WAS ALSO ON AMOXICILLIN DUE TO A ROOT CANAL DONE DAY BEFORE VACCINE HOSPITAL GAVE ME STRONGER PREDNOZONE PILLS TO TAKE 6 FOR 2 DAYS THEN 5 FOR 2 DAYS...ETC. SOMEWHAT LIGHTER ON DAY 2 TODAY IN RASH..STILL ALL OVER...BUT GETTING DARKER IN COLOR.
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| 64 | 2021-03-08 | muscle spasms | Severe muscle spasms (requiring a muscle relaxer); low grade fever (99.3) and chills. |
| 64 | 2021-03-09 | pain in extremity |
Very sore arm for 2 days. Headache started in the evening and had the next morning. Used cold wet ...
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Very sore arm for 2 days. Headache started in the evening and had the next morning. Used cold wet cloth at injection site and used the arm as suggested to relieve pain. Headache was a dull throb. Chose not to use Tylenol as I wanted to do nothing that might affect the efficacy of the vaccine. Just rested.
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| 64 | 2021-03-09 | feeling hot |
at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=...
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at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=127/85, P=83, T= 99, O2 sat 98%. Appears anxious. Stating "Oh my god. I can't believe I am having a reaction" multiple times. Fanning herself with her vaccine card frequently. Placed in front of a large fan by this RN. Pt states that the wind feels good. has stopped fanning herself. At 1430 reports mild lightheadedness, no sweating and reports she is ready to go . When this RN turned around pt was gone.
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| 64 | 2021-03-09 | tingling |
patient feels a slight tingling sensation on L hand. Vitals 97% RA 85 bpm 141/87 Bp 19 cpm #21 p...
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patient feels a slight tingling sensation on L hand. Vitals 97% RA 85 bpm 141/87 Bp 19 cpm #21 pt stable and sent home
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| 64 | 2021-03-09 | facial pain |
reports that she starting having a flutter in right side of chest ( a little catch) and then went aw...
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reports that she starting having a flutter in right side of chest ( a little catch) and then went away on the drive home from receiving vaccine. then 5 hours later her teeth and nose began to hurt. Fatigue, headache, nausea, continued pain in nose and teeth over the weekend. seen NP on Monday and was prescribed allergy meds and was told that this is symptoms of the vaccine. she reports today that the right side of her face is swollen and that she feels like there is a boil in her nose.
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| 64 | 2021-03-10 | pain in extremity |
Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when tryin...
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Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when trying to sleep at night. Pain when trying to do certain things at my job with my right arm.
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| 64 | 2021-03-10 | pain in extremity |
first dose - sore arm about 12 hours after injection lasting for approx 2 days. second dose - pressu...
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first dose - sore arm about 12 hours after injection lasting for approx 2 days. second dose - pressure in top of head about 17 hours after injection dissipated after about 4 hours after taking tylenol. second dose - nausea starting about 17 hours after injection and lasting approximately 20 hours. second dose - sore arm about 12 hours after injection very similar to sore are when you get flu shot
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| 64 | 2021-03-11 | flushing, tremor | 6 hours of Diarrhea, vomiting, flushing, headache, shaking. No fever |
| 64 | 2021-03-11 | numbness |
64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt repor...
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64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm. Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN 64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head. The history is most suggestive of a vagovagal episode.
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| 64 | 2021-03-11 | pain in extremity | Arm was sore at vaccination site on left arm for 24 hours only. |
| 64 | 2021-03-11 | pain in extremity | Extreme pain in both arms, hand swelling, could not bend. |
| 64 | 2021-03-11 | pain in extremity |
Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, ...
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Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained
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| 64 | 2021-03-11 | seizure, seizure like phenomena |
Seizure like activity within minutes after vaccine; pt does have history of seizure disorder as well...
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Seizure like activity within minutes after vaccine; pt does have history of seizure disorder as well as some non-epileptic spells
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| 64 | 2021-03-11 | tingling, flushing |
Tongue feeling ?stiff? or kind of fat like at the dentist, tingling in face and nose, mild swelling ...
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Tongue feeling ?stiff? or kind of fat like at the dentist, tingling in face and nose, mild swelling in lips. Possibly minor flushing of cheeks, but since I had had a mask on, not sure. Resolved after about 25 mins.
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| 64 | 2021-03-11 | numbness, pain in extremity |
Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unab...
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Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
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| 64 | 2021-03-12 | flushing, pain in extremity |
15 minutes after face flush. Later about 1:30 am, sore arm returned and face itching and 1 degree of...
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15 minutes after face flush. Later about 1:30 am, sore arm returned and face itching and 1 degree of temperature
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| 64 | 2021-03-12 | muscle spasms |
2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramp...
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2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramping while defecating ). Normally, if the cramping gets severe, I take one Hyosycamine Sulfate .0125 mg and the cramping stops within 10-15 minutes. The morning after the vaccine , starting at 6 am, I had severe cramping...took one Hyosycamine Sulfate pill and the severe cramping did not ease for 2.5 hours. I called my primary physician and she felt that this intensity/duration could have been connected to the vaccine. I was not producing any feces during this event, just severe episodic cramping. I also had the expected headache and chills. I felt stomach discomfort for the rest of the day. My doctor advised me taking the pill 3 times each day and two during an intense episode. I took one more pill at 2:45pm. I had another episode of severe cramping from 10:30-11:00pm , took two pills and then the cramping stopped and resolved in some diarrhea (two movements).
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| 64 | 2021-03-12 | tingling, numbness |
After vaccine administration patient started to feel in her left arm knumbness and tingling, and aro...
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After vaccine administration patient started to feel in her left arm knumbness and tingling, and around her mouth and down her legs, patient was removed from the vaccine cell and taken to the observation area, she was placed on a litter and blood pressure 150/86, HR 73 pulse ox 99 and her left wrist. patient was observed and follow up blood pressure was 143/90 HR 75. patient was observed for 15 more minutes . she was then being escorted out to go to her car and she became lightheaded and dizzy and unsteady she was then placed in a wheelchair and taken back to the observation area, her follow up blood pressure was 1 @ 104/70. Patient was placed on the litter in trendelenberg, Follow up BP @ 1341 was 140/83 HR 75 laying, sitting she was 158/98 HR 75, and then after standing for 1 min she was 172/109 HR 75. Patient reported no feelings of lightheaded or dizzy, she was taken in a wheelchair to her car to meet her spouse.
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| 64 | 2021-03-12 | burning sensation, tingling | Extreme headache, Burning Face and lips, Tingling hands |
| 64 | 2021-03-12 | flushing | Lightheaded, flushing. Evaluated by EMS (refusal to transport) Cleared |
| 64 | 2021-03-12 | flushing |
When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rat...
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When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rate increasing. I immediately began to monitor my heart rate with my Watch. My resting heart rate is in the 60?s. At the time I looked at the watch my heart rate was already in the low 100?s but was rapidly escalating until in a matter of a few minutes had reached 140 bpm and my head began to have a full sensation and I was becoming very shaky. I pulled over into the parking lot of a restaurant and asked them to call 911. As they were talking with the dispatch my pulse started to decline so I cancelled the request. I stayed at the restaurant until friends to could come pick me up. By the time they arrived my pulse was in the low 100?s. I took 2 Benadryl. I monitored my BP through the night and it did not return to the 60?s until 1:00 am. I took (2) 25 mg Benadryl at approximately 4:00 pm, took another 2 at around 9:00 pm when my heart rate started to escalate and then a final 2 before going to bed at 1:00 am. My pulse dropped back into the 60?s while I was sleeping and stayed that way through the night. I woke up with no further symptoms nor side effects from the shot. The throat tightness and flushing of the ears resolved after the first dose of Benadryl. I had no adverse reactions or significant side effects from he first dose of Pfizer.
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| 64 | 2021-03-13 | pain in extremity |
I had my second dose of the Pfizer vaccine on Tuesday at 4:30 pm. Wednesday morning, I woke up wi...
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I had my second dose of the Pfizer vaccine on Tuesday at 4:30 pm. Wednesday morning, I woke up with a moderate headache and some minor body aches. Those symptoms lasted throughout the day Around 5 pm, I developed at low grade fever ( up 2 degrees from my normal) which lasted 5-6 hours. My arm was mildly sore for 2 days. When I woke up on Thursday morning, I felt fine.
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| 64 | 2021-03-14 | difficulty speaking |
1318: Received 2nd Covid Vaccine 1330: Pt c/o chest tightness & throat swelling but had similar reac...
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1318: Received 2nd Covid Vaccine 1330: Pt c/o chest tightness & throat swelling but had similar reaction w/1st vaccine so took own pre-med and began own nebulizer tx immediately following administration of 2nd vaccine. Chest tightness and throat swelling not as bad as after 1st vaccine. Denies need for Epi pen or Benadryl 1333: BP 124/80 HR 78 RR 18 SpO2 100% NAD, voice sl hoarse, lungs CTAB, cardiac RRR, skin pale, warm, dry, no rash 1338: HR 76 RR 18 SpO2 99% 1340: Released home
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| 64 | 2021-03-14 | flushing |
Flushing, shortness of breath 64yo F h/o HTN c/o flushing sensation, mild blurred vision and feeli...
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Flushing, shortness of breath 64yo F h/o HTN c/o flushing sensation, mild blurred vision and feeling short of breath. Denies: cp, dizziness, n/v, weakness, no allergies to injectables, abdominal pain Allergies: narcotics sob Patient received vaccine @ 1438 - Vaccine: Pfizer Lot # EN6208 Initial: vitals- 152/86, HR 92, RR 22, o2 100% Temp: unable to take BG: 151 1454: Repeat VS 148/86, HR 74, O2 100% 1501: BP 135/83, HR 70 RR 20 O2 98%. - Patient reports SOB resolved. No more blurred vision or flush feeling Exam: CTAB, RRR
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| 64 | 2021-03-14 | tingling |
angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest;...
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angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-03-14 | pain in extremity |
dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhe...
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dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.
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| 64 | 2021-03-14 | flushing |
had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned brig...
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had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
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| 64 | 2021-03-15 | weakness, seizure | Beginning February 28, 2021 stroke, seizure, fever, headache and weakness. |
| 64 | 2021-03-15 | feeling hot |
Large, warm oval lump and redness a little larger than the bump. The redness continued to grow a l...
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Large, warm oval lump and redness a little larger than the bump. The redness continued to grow a little larger for 2 days and the lump began to itch. It has been 4 days and the lump and itching are still there. The redness seems to have retuned to the size of the lump currently about 2 inches by 1 inch. It is still warm to the touch. There is a little tenderness.
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| 64 | 2021-03-15 | tingling |
Tingling, feeling faint, itchy tongue, light headed, blood pressure checks: 09:43am 150/75, 09:45am...
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Tingling, feeling faint, itchy tongue, light headed, blood pressure checks: 09:43am 150/75, 09:45am 100/70 Epipen administered. Blood pressure at 09:48am 130/82 Transported at 09:57
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| 64 | 2021-03-15 | breast pain |
Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompa...
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Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompanied by mild mental fog, myalgia, intermittent low grade fever and marked depressed mood. Severe left breast pain and left axilla pain on the third day severe enough to wake from sleep. Lasted about 48 hours.
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| 64 | 2021-03-16 | tingling |
10 days after the 1st vaccine my lip and tongue started swelling and I took benadryl. Spoke to an a...
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10 days after the 1st vaccine my lip and tongue started swelling and I took benadryl. Spoke to an allergist and they did not think it came from the vaccine . 2nd vaccine which I had on Tuesday, early Thursday morning I woke up with itching and tingling all down my legs which is still continuing.
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| 64 | 2021-03-16 | feeling hot, tingling |
Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilatera...
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Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilateral occipital area. Some neck pain and traveling from neck to scalp. Today is 3/17/21 and the symptoms are still present but somewhat improved over the last week. The sensations are now mostly on the R side. I took Advil 400mg TID for 2 days and also applied a heating pad to the neck and back of head. I saw my PCP today as this is causing me a lot of anxiety, she prescribed Prednisone 40mg daily X 3 days.
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| 64 | 2021-03-16 | hot flush, pain in extremity, weakness |
With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rash...
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With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.
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| 64 | 2021-03-17 | facial paralysis, numbness |
20 Minutes after I get the shots I have numbness on the right side of the face. The following day I...
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20 Minutes after I get the shots I have numbness on the right side of the face. The following day I have dropping on the right side of the face. 7 days later the symptoms came back worst and I was Advice by Doctor to go to ER to rule out stroke. I spend 2 days in the Hospital, every thing came back negative for stroke. I did follow up with my regular doctor and neurologist. I continue to have numbness in on the right side of my face and my tonged and pressure in my head. I register in V-safe but no one called me. I also try CDC but no results. I HAVE A 3,000 Hospital bill .
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| 64 | 2021-03-17 | tremor, hot flush, weakness |
After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I...
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After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I was experiencing fast heartbeat. I pulled over the car, and then I was shacking. I opened the window to get some fresh air, and drunk water. I could not moved or do anything. I waited in my car for over 20 minutes hoping that I would feel better. I was still feeling weak and shacking. Finally a member of my family came to pick me up. and took me back to the church which was less than one mile. I explained the situation, they told me that they did not have a doctor on premise and to contact my primary care physician or to go to an emergency care facility. I started to shack less. So the member of my family took me back home and I just relaxed while I had chills for two hours.
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| 64 | 2021-03-17 | burning sensation |
Developed burning in L buttock and labia on the evening of the vaccine (3/13). This progressed to s...
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Developed burning in L buttock and labia on the evening of the vaccine (3/13). This progressed to shingles with urinary retention by 3/17
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| 64 | 2021-03-17 | pain in extremity |
Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily ...
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Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily in the right bicep I feel like muscle is getting weak. I have iced it and taken Advil and Tylenol. Nothing takes the pain away. Additionally the pain wakes me up from sleep.
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| 64 | 2021-03-17 | weakness |
Within 15-minutes of vaccination, the patient reported chest tightness and was concerned she was hav...
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Within 15-minutes of vaccination, the patient reported chest tightness and was concerned she was having an asthma attack. EMS evaluated the patient on-site. The patient was hypertensive (150/85). The patient's EKG demonstrated NSR, rate 82bpm, no ST elevations. EMS administered 8L/min O2 and DuoNeb (2.5mgAlbuterol/0.5mgIpratoprium). EMS transported the patient to Emergency Department. In the ED, the patient reported general weakness and feeling mildly lightheaded in orthostatic position. The patient noted feeling better after taking their inhaler and receiving the DuoNeb treatment. Labs were non-actionable. The physician administered 1L normal saline and discharged the patient with diagnoses of Chest tightness, Adverse reaction to vaccine, Asthma, Orthostatic Lightheadedness. Patient was prescribed Albuterol Sulfate on discharge.
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| 64 | 2021-03-17 | flushing, feeling hot, pain in extremity |
Within approximately 25 minutes, began feeling very flushed in my face (face felt very, very hot). R...
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Within approximately 25 minutes, began feeling very flushed in my face (face felt very, very hot). Rash on my cheeks and some on neck. For about five minutes, I felt an "awareness" of my throat (around the area in the front where the Adam's apple would be located. This went away. I had the flushed rash for approximately 3 hours and then it resolved and had no further issues. I did not seek medical treatment. I had mild symptoms from the actual vaccine. Soreness in right arm for approximately 1 day.
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| 64 | 2021-03-17 | weakness |
Woke up with FLU LIKE symptoms the morning after the injection ( Chills, body ache, debilitated al...
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Woke up with FLU LIKE symptoms the morning after the injection ( Chills, body ache, debilitated all day long)
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| 64 | 2021-03-17 | feeling hot, feeling cold |
patient stated she felt like her blood pressure was going up right after vaccine administration. I t...
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patient stated she felt like her blood pressure was going up right after vaccine administration. I took her BP and it was 190/112. She got hot and then cold and shaky. I got her some water and propped her feet up and took her blood pressure 3 or 4 more times over about 20 minutes then we decided to call 911.
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| 64 | 2021-03-18 | tremor |
2:30 am uncontrollable shaking, chills, lasted 3 hours. All next day fever 102, body aches, fatigu...
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2:30 am uncontrollable shaking, chills, lasted 3 hours. All next day fever 102, body aches, fatigue, nausea, last 20 hours.
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| 64 | 2021-03-18 | pain in extremity, flushing, weakness |
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little...
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Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
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| 64 | 2021-03-18 | burning sensation, tingling, flushing |
Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later i...
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Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later it spread to back of the neck and went up through the scalp at the back of the head to the crown of the head. Headache the whole time. Face returned to normal in 90 minutes. Scalp in 2 1/2 hours. Muscles aches starting in left arm, moved to left leg and then to right leg. Headache is persistent but mild 4 hours later.
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| 64 | 2021-03-18 | feeling hot |
Patient complained of feeling hot and diaphoretic and then complained of chest pain and some shortne...
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Patient complained of feeling hot and diaphoretic and then complained of chest pain and some shortness of air
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| 64 | 2021-03-18 | numbness, tingling |
Reports to ED 2 days after first Pfizer vaccine with SOB, chest pain, headache, fatigue. Normal EKG ...
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Reports to ED 2 days after first Pfizer vaccine with SOB, chest pain, headache, fatigue. Normal EKG and troponin, normal D-dimer. Likely normal vaccine reaction. Discharged home in stable condition. 3 days later presents to PCP, still symptomatic and now with tingling all over body and slight numbness to right side of face and arm. No deficits, likely extended vaccine reaction.
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| 64 | 2021-03-18 | tingling |
Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to wait...
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Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to waiting area for 15 minutes. Left to go home, my face cheeks started to turn red within the next 30 minutes. A couple of hours later my skin was tingling, itching, even inside my ears, around my ankles. Took some Benadryl, knowing that it was an allergic reaction, but it didn't help. Couldn't sleep, felt like my skin was crawling. Around 4 am my skin finally calmed down. Sent a message to my Dr. to let him know what happened. Still some lingering itching the next day. Today is Friday March 19, most everything is back to normal.
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| 64 | 2021-03-18 | discomfort |
This was my second COVID vaccine. At 23.5 hours since the shot every joint in my body lit up and my...
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This was my second COVID vaccine. At 23.5 hours since the shot every joint in my body lit up and my whole body felt like dead weight. I started coughing as well. I left work, went straight home and was in bed by 5:00PM. I slept all night, got up @ 4:30 AM and went to work. I felt 100% better. Just my shoulders kind of ached and my back was achy but that has mostly subsided by 11:00 AM today.
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| 64 | 2021-03-19 | tenderness, numbness |
3/19 Friday, Moderate soreness behind the left eye, and Facial Swelling on Lt. cheek predominatel...
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3/19 Friday, Moderate soreness behind the left eye, and Facial Swelling on Lt. cheek predominately under the eyes and slight numbness and tenderness. Saturday 3/20, headache is dissipating however swelling under left eye is the same
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| 64 | 2021-03-19 | tingling |
About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About ...
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About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About 2 hours later my blood pressure was high - 150/90 (checked on a home monitoring machine) and then I started with heart palpitations which lasted throughout the night - did not sleep more than an hour or two. Next day around noon had diarrhea a few times - tired and weak. Slight headache for about 4 days. Nausea for about 3 or 4 days.
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| 64 | 2021-03-19 | tremor |
Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to sh...
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Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to shock (shaking, rapid eye movements)
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| 64 | 2021-03-19 | weakness, pain in extremity | Dizzy, headache, weak, sore arm, sore muscles very tired |
| 64 | 2021-03-19 | tingling |
The vaccine seems to have reactivated the post herpetic neuralgia from my ocular shingles in 2013. I...
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The vaccine seems to have reactivated the post herpetic neuralgia from my ocular shingles in 2013. I had a dreadful case and suffered from intense PHN for about 3 years. It has grown much less severe during the past 2-3 years. The vaccine seems to have reactivated the PHN - not the full shingles but the pain and tingling is much much worse. I wonder if there will be a worsening of the symptoms with my second COVID vaccine. FYI - I had 2 shingles vaccines last year, Shingrix, and had the older shingles vaccine about 4 years ago. Do you know if taking and antiviral would be a good idea?antiviral medicines?acyclovir, valacyclovir, and famciclovir?
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| 64 | 2021-03-20 | migraine |
Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection...
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Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection site and there is a small lump
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| 64 | 2021-03-20 | breast pain |
Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--coul...
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Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--could see swelling in armpit and feel lump. by evening could feel pain down into left breast. following morning--could see little "lumps"/swollen areas on left side of left breast. Armpit still swollen and sore
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| 64 | 2021-03-20 | pain in extremity |
Pain in arm could not lift above head. Severe chills. Was checking and teeth chatting. Headache for ...
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Pain in arm could not lift above head. Severe chills. Was checking and teeth chatting. Headache for two days straight.
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| 64 | 2021-03-20 | pain in extremity |
Upper back soreness began ~ 4-5 days after injection. then it began to migrate from the whole upper ...
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Upper back soreness began ~ 4-5 days after injection. then it began to migrate from the whole upper back to the left side near the deltoid and trapezius and get stronger. Then migrate up my neck. It tends to move and is not related to any individual muscle. The pain did not respond to heat, stretching, or massage. It made it feel worse at times. I am very tolerant of pain and rarely take painkillers. I began taking aspirin, oil, then Advil. Then I was in such pain 10 days after the shot, I searched and found my leftover emergency from my hip surgeries. This back and neck pain was more painful to me than hip surgery!
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| 64 | 2021-03-20 | feeling hot, tremor |
allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontro...
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allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation . The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.
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| 64 | 2021-03-20 | tingling, pain in extremity, numbness |
pins and needles in the left arm/pins and needles feeling right arm; pain in left arm; numbness in f...
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pins and needles in the left arm/pins and needles feeling right arm; pain in left arm; numbness in face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: unknown, Formulation: Solution for injection, Lot number: EL3302, Expiration date: unknown), via an unspecified route of administration in left arm at the age of 64-years, on 20Jan2021, at single dose (dose number: 1) for COVID-19 immunisation. The patient's medical history included positive Covid test (tested positive is either 03Jan2021 or 07Jan2021, does not remember exact date. Got positive test on a Sunday and retested on Tuesday). Concomitant medications were none. Caller states she is a veterinarian, had Covid blow through the office, states during that time she got a positive Covid test but it was an inconclusive thing, states she got tested 4 days later and it came back negative, so she went ahead and got the Pfizer vaccine on 20Jan2021, states since she got the vaccine she has felt pretty bad pins and needles in the arm that she got it in (in 2021), clarifies her left arm, states it has moved up into her face, makes her feel like she wants to drool, states the feeling in her face is more numbness than the pins and needles feeling, states it is not drooping or she is not seeing a Bell's palsy kind of thing, just that she is not really talking properly out of the left side of her mouth because of it. States she also had the pins and needles feeling in her right arm but that has improved some. I still have some soreness in my left arm. Caller states she thought she may just get the second booster shot (booster scheduled on the 10Feb2021) in the opposite arm, but that she cannot afford to have both arms feeling like this as she performs surgeries and stuff. Caller states that maybe the positive test she thought was a false positive was actually a real positive and this could be why she is reacting this way. Caller states the symptoms started maybe a couple of days after the vaccine, unknown exact dates. The pins and needles in her hands on the left side where vaccine was given was worse than other side, no longer experiencing this symptom. It's now on left side of her face, numbness that has been persistent a couple of days after the vaccine. The events were reported as non-serious. The outcome of the events was not recovered.
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| 64 | 2021-03-21 | pain in extremity |
Sore left arm, chills, monitored my blood pressure. I noticed elevations started to occur after the ...
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Sore left arm, chills, monitored my blood pressure. I noticed elevations started to occur after the second dose. I was on Lisinopril before my first dose vaccine my doctor changed my BP medication to Losartan. I was basically allergic to the Lisnopril medication. My doctor increased the dose of the Losartan.
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| 64 | 2021-03-21 | inability to speak | Tachycardia with Dysnomia |
| 64 | 2021-03-22 | nerve pain |
I have fibromyalgia and follow the injection the nerves started firing like crazy. After they calmed...
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I have fibromyalgia and follow the injection the nerves started firing like crazy. After they calmed down I felt severely drained like post seizure? I was in bed with body aches everywhere I have been injured for 3 days.
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| 64 | 2021-03-22 | pain in extremity | Severe pain in left hip area going into upper left thigh |
| 64 | 2021-03-22 | pain in extremity |
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well o...
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dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
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| 64 | 2021-03-22 | difficulty speaking |
itchy feet, hands, eyes, voice became hoarse within 15 minutes of shot; took Benadryl immediately (a...
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itchy feet, hands, eyes, voice became hoarse within 15 minutes of shot; took Benadryl immediately (as I do for food allergies); cleared up symptom of voice, but not itchiness; took 3 Benadryl spaced out over 1.5 hours, under care of nurses/EMT at site, but hadn't cleared up symptoms, so nurses directed me, with my accompanying friends, to an ER, where physician gave me Pepcid (rather than a steroid which he said would compromise the effect of the vaccination) and told me to take Benadryl every 8 hours for next 3 days
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| 64 | 2021-03-22 | numbness |
soon after receiving vaccine my lips were tingling then within an hour the left side of my face was ...
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soon after receiving vaccine my lips were tingling then within an hour the left side of my face was numb - like I had novocaine. The shot was given to me in my right arm - lasted a few hours and then was gone
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| 64 | 2021-03-23 | weakness, feeling cold |
After 10 minutes of receiving shot I felt a cold surge in my left arm and felt lightheaded. I felt ...
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After 10 minutes of receiving shot I felt a cold surge in my left arm and felt lightheaded. I felt sweaty, weak and faint. The EMTs quickly came to my side and administered my blood pressure and oximeter. When I continued to feel lightheaded they took me to a back room and hooked me up to an EKG with electrodes throughout my body. They retook my blood pressure and told me that my blood pressure had risen to 180/90 earlier! After sitting for a while they took it again and read 160/80. They told me to get it checked again, asked if I need go to ER, Walk-in or doctor. They walked me out to my husband, who was waiting in car. I went home and slept for 11/2 hours. Took my blood pressure the next day 3 times and averaged in the low 120s.
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| 64 | 2021-03-23 | numbness, tingling |
Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus...
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Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus is sore and I have numbness on the left side of my face. The numbness is on the left jaw, the cheek, the eye brow and forehead. It's itchy and tingly. It feels somewhat like when a part of the body is coming out of being asleep and it tingles. This is the second day of the numbness. I did not expect this reaction to this COVID-19 vaccination and I have never had such a reaction to vaccinations in the past. I read on the internet of people getting Bell's palsy from the COVID-19 shot and wondered if this is similar. With this reaction from the first COVID-19 shot, I'm concerned what my reaction might be if/when I have the 2nd vaccination.
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| 64 | 2021-03-23 | facial pain, nerve pain |
Extreme (!), severe pain in LEFT jaw/remple/upper lower molars. Radiating to back of eye, ear/temp...
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Extreme (!), severe pain in LEFT jaw/remple/upper lower molars. Radiating to back of eye, ear/temple area, upper and lower molars. Started on 3/18 lasted 3-4 hours then went away. Another attack on morning of 3/19 - lasted several hours and went away. Another attack afternoon of 3/19 - even more sever. Went to E.R. at the hospital. Thought it was an abscessed tooth at first but later realized that the tooth itself was not really sensitive. Diagnosed as trigeminal neuralgia by a nurse practitioner. Prescribed Baclafen and Pennicillian (in case it was caused by tooth abscess). Baclafen was successful in moderating the pain to tolerable levels. Have had several smaller attacks since when eating (even though I am avoiding chewing on left side). Seems to be set off by hot or cold foods possibly(??). No noticeable swelling . The thing is that I have NEVER had this kind of nerve pain in my jaw or anywhere else at all (save for an attack of Shingles 2 yrs ago) . possibly this is just a coincidence but it seems odd that this occurs two weeks after the injection when my health has been fine thus far.
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| 64 | 2021-03-23 | pain in extremity |
First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, heada...
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First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, headache, hives Allergist Dr. recommended Allegra
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| 64 | 2021-03-23 | tingling |
Numbness/ tingling in lips and left side of head/face. I returned to Clinic area, had elevated B/P ...
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Numbness/ tingling in lips and left side of head/face. I returned to Clinic area, had elevated B/P and took claritin.
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| 64 | 2021-03-23 | difficulty speaking, tingling |
Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so. Followe...
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Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so. Followed by tingling tip of tongue and portion of lower lip tingling. Itchy/tingly sensation back of throat on right with very slight hoarseness and slight chest tightness. Also noted some ectopy on my Kardia monitor--looked like PACs, but lots of interference in the reading. Symptoms not severe enough to use albuterol inhaler. By two hours, they had completely abated. Primary care doctor notified on 3/24/21 for counseling as to future immunization plan.
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| 64 | 2021-03-24 | migraine |
24 hours after receiving shot I experienced severe vomiting that occurred every 20 mins for the firs...
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24 hours after receiving shot I experienced severe vomiting that occurred every 20 mins for the first 12 hours..every hour for the 2nd 12 hours and every couple of hours for the third set of 12 hours for a total of 36 hours. Unable to hold down even a drink of water. I suffer from migraines and had one during a 3 day span from Sunday until Tuesday evening 9 pm. Now a full 4 days from the vaccine I still have nausea and extreme fatigue.
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| 64 | 2021-03-24 | flushing |
Almost immediately after receiving the shot, I began having a metallic taste in my mouth. It lasted ...
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Almost immediately after receiving the shot, I began having a metallic taste in my mouth. It lasted about 4 hours. In addition, I experienced mild flushing (lasting about an hour) and extreme tiredness., which is still ongoing the day after.
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| 64 | 2021-03-24 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old Female...
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Bell's palsy; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 at single dose in left deltoid for COVID-19 immunisation at the age of 64-year-old. Lot number was EN6200. Relevant medical history and concurrent conditions included Herpes zoster/ shingles, Bells palsy, overweight. Concomitant medications included ergocalciferol (Vitamin D) for her bones and that kind of stuff. First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was received on 21Jan2021 for COVID-19 immunisation at the age of 64-year-old. Historical vaccine included typhoid, malaria and yellow jacket. Patient initially confirmed she has had no reactions after prior vaccinations. On 06Mar2021 at 02:30, the patient experienced Bells palsy; the event was considered Medically significant; the patient visited emergency room; the patient was given Zanamivir, antiviral in the Emergency Room. The patient had been told by other people that she should get started on a steroid, so she started prednisone, prescribed by the NP at her primary care. Patient had right facial paralysis right at the time of report, it was slightly worse than when she first noticed it. The patient did not think she has reached the maximum of the Bells Palsy and she had to drink coffee out to of a straw and issues with her words. The patient did not recover from the event. The reporter mentioned that she has had several family members who have had Bells Palsy. The odds that she received something that could trigger some kind of immune response, the time frame, the fact she got the vaccine, also fact she has a history of shingles she would have to associate with the vaccination. The reporter had done mission work and has never had a reaction to any of the vaccines that she received for that.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-03-24 | hot flush, pain in extremity |
On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is s...
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On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is still and issue. A few days later I got hot flashes at night and had disturbed sleep. The headache has at times caused ear ringing, but not all the time. March 23 I had chills at night. March 24th, I had chills all day. March 25 I still have the headache and my right arm hurts which is where I have lymphedema.
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| 64 | 2021-03-25 | weakness |
Felt fine for about 6 minutes after receiving vaccine. Then started feeling sick and got worse quic...
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Felt fine for about 6 minutes after receiving vaccine. Then started feeling sick and got worse quickly. Told nurse felt bad and also pulse was fast. When nurse took my pulse it was 100. Regularly my pulse is around 60. She then took my blood pressure and it was 179/? My B/P is normally 106/65. The nurse said my color was bad. Gradually over an hours time started feeling better and went home. Next day I felt malaise and tylenol helped. Today I am a bit weak but better. That was my 1st shot
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| 64 | 2021-03-25 | migraine |
Migraine pet-symptoms began around 1:30Pm, progressing into a full blown migraine 7:30-8:30 PM. I wa...
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Migraine pet-symptoms began around 1:30Pm, progressing into a full blown migraine 7:30-8:30 PM. I was afraid to take my sumatriptan medication at onset of migraine due to lack of knowledge of impact of efficacy of vaccine. I tried treating with Advil alone. Intense pain persisted through night and next day last night. I finally took a sumatriptan at 3:30 AM this morning. As of 7:28 AM today, I am pain free
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| 64 | 2021-03-25 | tingling |
Pain and tingling in my lower left back started 2 days after the second vaccine. By 5 days after th...
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Pain and tingling in my lower left back started 2 days after the second vaccine. By 5 days after the second vaccine. I had a rash diagnosed on 3/29/21 as shingles. I had never had shingles before.
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| 64 | 2021-03-25 | muscle spasms | Pain in and muscle cramps in back, arms,legs,hands&feet |
| 64 | 2021-03-25 | feeling hot | Tachycardia body was on fire high bp shaking Nausea feeling of impending doom headache |
| 64 | 2021-03-26 | tingling |
6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 ...
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6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days . tingling of hairline and under the eyes, eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.
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| 64 | 2021-03-26 | pain in extremity |
After a 30 minute wait from the shot upon driving home I had a feeling of a very tight grip on the ...
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After a 30 minute wait from the shot upon driving home I had a feeling of a very tight grip on the back of my neck at the base of my skull. It was really tight. My ears itched. This lasted 20 minutes. That night I had severe bone and muscle pain in my upper legs. I cried all night. the next day I started taking Tylenol. This helped. My upper legs still hurt but I can stand it now.
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| 64 | 2021-03-26 | weakness | Onset of weakness, dizziness, blurred vision, sweating, harder to breathe |
| 64 | 2021-03-26 | pain in extremity |
Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24...
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Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24 hour later. I woke with a fever (my feet were especially warm) Body aches, especially my joints. Mild cough I have taken ibuprofen and acetaminophen, which help. This was my second Pfizer dose. Other than a mildly sore arm, I had no issues with the first dose
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| 64 | 2021-03-27 | discomfort |
12:00 noon, began to feel nauseous, achy, scratchy eyes. Afebrile. ?Woozy? feeling increased. Un...
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12:00 noon, began to feel nauseous, achy, scratchy eyes. Afebrile. ?Woozy? feeling increased. Uncomfortable to read, watch TV. Slept x 1-2 hours. Symptoms subsided minimally while lying down. Increased upon standing. Could not eat. 9:00 pm, s/sx started to subside. Was able to eat some soup. By 10:00, felt relatively normal, but symptoms minimally returned upon standing. 8:00 next day, feeling normal
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| 64 | 2021-03-27 | tremor, migraine | Violent trembling from chills (3 hours), high fever (16 hours), diarrhea, vertigo, migraine |
| 64 | 2021-03-27 | muscle spasms | Vomiting, cramps, Fever 101.2, Chills, headache still experiencing |
| 64 | 2021-03-27 | tingling, pain in extremity |
Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingli...
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Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingling and pain in the other arm from the wrist up to my neck. The medics took me into a room to lie down for 30 minutes and it seemed to pass. I have felt off and foggy for the past 3 weeks. And now for the past 3 days, I have been feeling the same feeling of lightheadedness and dizziness that I had after the shot throughout every day. I am sure this is related to the vaccine. I never had anything like this in my life. I did not take the second shot and still feel awful. I have spoken to people who had the same immediate allergic reaction.
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| 64 | 2021-03-28 | numbness, nerve pain, tremor, discomfort, pain in extremity |
I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right h...
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I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right headache, jaw pain, numbness in eye and ear and face. Heavy,wheezines in right lung. A total of 6 Tylenol eased pain. Day 3. Tremors. Body feels as if it's vibrating inside. Ongoing
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| 64 | 2021-03-30 | tremor |
Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a s...
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Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
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| 64 | 2021-03-30 | burning sensation, weakness |
she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of...
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she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation. The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported. On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were. The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
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| 64 | 2021-03-31 | inability to speak |
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a...
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At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
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| 64 | 2021-03-31 | feeling hot |
Passed out at the casino and transported to Hospital b y Ambulance. I Was kept overnight. Feeling ...
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Passed out at the casino and transported to Hospital b y Ambulance. I Was kept overnight. Feeling light headed , dizzy and hot. . 1 day after the second doze of the pfizer shot. Passed out approximately 15 minutes after filling the symptoms.
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| 64 | 2021-03-31 | pain in extremity |
acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ult...
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acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ultrasound diagnosis of acute left leg DVT (blood clot) diagnosed.
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| 64 | 2021-04-02 | pain in extremity |
headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad press...
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headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date. On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday. Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high. Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.
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| 64 | 2021-04-06 | pain in extremity, tingling |
Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling...
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Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot. Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours. Was discharged on 50 mg Prednisone X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
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| 64 | 2021-04-07 | tremor |
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; mal...
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Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered. Information about Batch/Lot number has been requested.
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| 64 | 2021-04-07 | cold sweat |
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ...
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pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
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| 64 | 2021-04-09 | pain in extremity, weakness |
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain...
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feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
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| 64 | 2021-04-09 | difficulty speaking |
horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives...
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horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; she was a little bit red; blood pressure lowered a little bit; This is a spontaneous report from a Pfizer sponsored Program . A contactable Physician reported for herself that. A 65-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Feb2021 15:00 (Batch/Lot Number: FL9267) as SINGLE DOSE for covid-19 immunisation (Age at vaccination was 64 years). Medical history included immunocompromised and she is a very allergic person and can treat allergies. Concomitant medications were not reported. On an unspecified date patient experienced horrible hives and hoarseness and itching, she was a little bit red and blood pressure lowered a little bit. It was reported that after the 1st dose of the Pfizer COVID Vaccine, it seems like she was a little bit red and she did not pay much attention to it then at night on the 2nd day and that night became horrible hives and hoarseness and itching; caller states these symptoms are not ongoing and lasted about 4-5 days; states the 2nd day the hives started at night about 24 hours over. Caller states then the symptoms disappeared and she used an antihistamine Benadryl and every time she takes it is 50mg and she then used Zyrtec 10mg and only used the Zyrtec twice and had terrible side effects from the Zyrtec and did not like it and prefers the Benadryl; no further details provided by the caller. Caller states because she was an allergic subject, she always has Benadryl at home. the first night after she had the Pfizer Covid vaccine, she had her epipen with her but was following her blood pressure and pulse and the blood pressure lowered a little bit but not terribly and the pulse was the maximum of 99 so she decided not to go to the emergency room and she stayed home and did not do the epipen; states she decided to stay home and monitor herself but she was ready to go to the emergency room if needed and by 9:00pm she seemed fine and only her blood pressure had slowed a little bit and her pulse at one time went to 99 and she did not do the epipen; despite further attempts at clarification, the information is captured as stated by the caller. Caller states the 2nd dose (lot number EN6204) was administered on 13Mar2021 around 12:00pm. The patient underwent lab tests and procedures which included blood pressure measurement: lowered a little bit, heart rate: maximum of 99 on, sars-cov-2 antibody test: negative on 29Mar2021. Reporter seriousness for antibody test that was done came back negative was Medically significant. Outcome of the events was recovered on unspecified date.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-04-11 | discomfort | c/o numbness in the lips and heavy tongue |
| 64 | 2021-04-17 | pain in extremity |
This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 06Apr2021 13:00 at single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06APR2021 at around 1PM. She woke up in the middle of night (she usually does so). When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which is unusual because she liked drinking coffee. On 07APR2021, her heart rate (HR) is 96 beats per minute (BPM), which is high because her usual HR is 60 BPM. Her oxygen levels are normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She asked if she could take Ibuprofen. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389552 Same reporter/drug/AE, different patient
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| 64 | 2021-04-17 | burning sensation, numbness, sensory loss |
possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 whe...
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possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 when she was in the hospital/heart rate dropped; her right arm, the right side of her face, and her right knee were numb/ she has numbness in her right finger and right thumb; face feels like its burning; her vision was kind of blurry; sensational loss in her right hand; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; eye was super red; rupture of a blood vessel in her eye; blood clot in eye; This is a spontaneous report from a contactable nurse (reported for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER2613, expiry date not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 at a single dose for covid-19 immunisation. Medical history included ongoing hypertension from 1900 wherein blood pressure was high prior to her atrial fibrillation medications; A fib (atrial fibrillation) from 2016 and ongoing; and ongoing heartrate low. As a child the caller had the vaccine in the sugar cube (unspecified) and her mouth was swelling from it; and stated that patient's sister was hospitalized after receiving the same vaccine. Family medical history included mom has hypertension. Concomitant medications included apixaban (ELIQUIS) taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 5 mg twice a day; sotalol taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 80 mg, twice a day; and diltiazem taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 180 mg, once a day. The patient was a healthcare worker and she has had friends who have died from covid. The patient had no previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). The patient stated she had the first dose of the vaccine and had a TIA (Apr2021) and rupture of a blood vessel in her eye 20Mar2021. The TIA was on Monday (Apr2021) and she was supposed to have her second dose tomorrow (09Apr2021). She stated she may get it but she is not taking it tomorrow because she is still having residual symptoms. She asked what the length of time she can wait to get it before she has to restart. Patient reported that after she got her first vaccine she had a ruptured blood vessel in her eye the next day (20Mar2021). She put warm and cool compresses on her eye then the ruptured blood vessel subsided. The ruptured blood vessel came back again a few days later and this time it was the entire sclera. She developed blood clots in her eye and the doctor said it probably wasn't from the vaccine (Mar2021). She was supposed to get her second dose of the vaccine tomorrow 09Apr2021 but she was going to hold off for now. She then had a TIA (Mar2021) and became hospitalized because of it from 06Apr2021 to 07Apr2021. The patient has ongoing atrial fibrillation but has been taking her medication religiously. She believed that the TIA was from the vaccine as there was no explanation as to why it happened. Her heart rate was low anyways from the medications (dates unspecified) but it dropped to 35 when she was in the hospital (Apr2021). The patient's primary care provide was not the attending in the hospital when the caller was hospitalized. Furthermore, it was reported that on 21Mar2021, patient's eye was super red but only on one side of her left eye. On Tuesday, 22Mar2021, caller went to see her primary care provider and they told the patient to put a warm compress and no eye drops in her eye, that helped. Then that Friday, 25Mar2021, the patient's sclera looked like her eye was bleeding and her pupil started turning a different color. Then last Monday (Apr2021), the patient woke up and her right arm, the right side of her face, and her right knee were numb she got up and went to see if she had a facial droop and did not. The patient thought it was from her sleeping wrong, but these symptoms did not go away. The patient went to the Emergency Room where they did a CT of her head and neck, with and without contrast which was negative. The patient was admitted on 06Apr2021 to the observation unit where they did an MRI and ECHO, which were both negative and she was diagnosed with a TIA and possible pinched nerve (Apr2021). The patient denied any heavy lifting prior to this event other than normal day to day things. The patient was discharged on Wednesday 07Apr2021. The patient's face felt like its burning, she has numbness in her right finger and right thumb. Physical therapy and occupational therapy said the patient should be okay but to be careful with things that were hot because she was at risk of burning herself. The second time the patient's eye became red, her vision was kind of blurry (Apr2021) and she didn't know if the blood was in her pupil. The only deficit that the patient has now is sensational loss in her right hand (Apr2021) and that should improve per the occupational therapist at the hospital. The caller was supposed to get the second dose of the vaccine on 09Apr2021 but she doesn't want to take it while she is having these symptoms. Results of tests and procedures for investigation of the patient included: head ct with and without contrast: negative on 06Apr2021; MRI brain: negative on 06Apr2021; Echocardiogram: negative on 07Apr2021; speech evaluation: passed on 07Apr2021. The patient asked what the efficacy is after one dose and if a booster will be needed since she is only protected for 6 months. Patient asked if she needed to restart the series of vaccinations if she doesn't get the second vaccine tomorrow 09Apr2021. The events ruptured blood vessel in eye, blood clot in eye, sclera looked like her eye was bleeding, eye was super red were reported as serious medically significant, and heart rate dropped as life-threatening. As reported, the events required emergency room and physician's office visit. Therapeutic measures were taken as a result of the events rupture of a blood vessel in her eye, and eye was super red. The outcome of the events reported was unknown. As per reporter, the events ruptured blood vessel in eye, blood clot in eye, and heart rate dropped were related to the covid BioNTech vaccine.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-04-21 | tremor, feeling jittery, pain in extremity |
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef...
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Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
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| 64 | 2021-04-24 | sensory loss, tremor |
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las...
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Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
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| 64 | 2021-04-24 | pain in extremity, muscle twitching, seizure, tremor, weakness |
I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hea...
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I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.
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| 64 | 2021-04-24 | numbness |
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve...
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passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
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| 64 | 2021-04-24 | weakness |
she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness...
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she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1 via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-24 | weakness |
slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situ...
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slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situation, She stated this pain has been going on since Thursday night; I started headache with my TMJ and the left side of face; I don't remember a lot of it, we're like that, I can't concentrate, around in my ear; it hurts to open my mouth really wide sometimes; bothers to swallow; just actually feeling unwell; Spot below your jaw bone in your neck; pain in my ear; I still feel very tired; messed with her TMJ on the left side; extremely tired; This is a spontaneous report of a contactable consumer (reported for herself). A 64-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm, administered on 30-Mar-2021 at 14:45 (Batch/Lot number: ER8727) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes blood pressure and cholesterol. Concomitant medications included ascorbic acid/rosa canina fruit (VITAMIN C & ROSEHIP) (started 20-25 years ago) at 1000 mg, twice a day for immune system, ongoing, calcium phosphate/colecalciferol (CALCIUM plus D) at twice a day for bone health. Vitamin E (Capsule, soft) for cancer preventive 400 iU, once a day(night) , potassium acetate (Solution for injection), 99 mg, twice a day, magnesium sulfate (Solution for injection) 400 mg, once a day (morning) for unspecified indication, multivitamin/sambucus nigra/sodium, zinc (Chewable tablet) one every other day; fish oil at 500 iU, once a day (morning) taken for cholesterol; colecalciferol (VITAMIN D3 1000) at 1000 iU, twice a day taken for an unspecified indication from 06Apr2021 and ongoing; ascorbic acid/betacarotene, calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) at every other day taken for Hair; pravastatin at 80 mg, once a day(night) taken for cholesterol; zinc chloride (Solution for injection) at 50 mg, twice a day taken for bone health and immunity health; acetylsalicylic acid (ASPIRIN (E.C.) at 81 mg,twice a day, loratadine at 1 tablet taken for an unspecified indication from Oct2015 and ongoing for all drug from an unspecified start date and ongoing. ibuprofen (ADVIL 12 HOUR); amlodipine besilate (Film-coated tablet) taken for blood pressure; atorvastatin calcium at 80 mg taken for cholesterol; omeprazole; fluoxetine hydrochloride (FLUOXETIN) 40 mg. It was reported that she had the first dose of the vaccine and has been having fatigue/tiredness/no energy. She stated she would compare it to if you have had surgery and go home and the anesthesia keeps kicking you. It makes her want to sleep a lot. Additionally, around her ear/jaw/TMJ area when she pushes on her neck it sends shooting pain into her ear. She asked if this could be a lymph node situation. She stated this pain has been going on since Thursday night. She asked if these symptoms are from the vaccine and if they just have to run their course/how long do they last. She took an Advil for swelling but it did not do anything. She was scheduled to get her second dose a week from today. It was also reported that Vitamin C she started taking it years ago, 20-25 years ago for immune system, Calcium plus D she started taking it years ago. She is supposed to take at least 1000. Vitamin E she started taking it many years ago. Regarding Potassium her doctor wants her to continue to take that. In her lab work last year her potassium was low. States she started taking it at least 20 years ago, longer than that, not sure. Magnesium the doctor before told her she should be taking at least 400 mg so she does when she can get it, sometimes she takes 250 mg. Caller states she started taking it 20 years ago. Multivitamin it was Normal CT Plus Equate, same as Centrum. States it had Lutein and she started taking some several years ago. Products Multivitamin was taking for general purposes, health protection. Additional Information for Fish oil states she accidentally grabbed 1000 IU so right now is taking 1000 IU. States she started about 10 years ago. States her cholesterol reporting is really good. Products vitamin d3 she was concerned she wasn't getting enough and she just started taking it a week ago. Pravastatin: Caller states it was good for other things too but the main reason was cholesterol. States she was guessing maybe in 2009, usually takes 40 mg and he raised it to 80 mg. Zinc she started taking it maybe 15 years ago. coasted aspirin she started taking it probably 3 years ago. Loratadine it was over the counter, Equate Loratadine. States it seems to work pretty well. She had a cough that wouldn't go away in the fall, the doctor told her to take one every day. Caller states from the day she got her vaccine she has been extremely tired, no energy, and is normally pretty quick on and more her feet. Sometimes she takes 3 naps a day, and still sleeps for eight hours. She is just really, really tired. She feels like when she's had surgery and came out of the hospital and anesthesia is kicking her and makes her want to sit. States it's messed with her TMJ on the left side but it continued to get worse, feels kind of like the mumps. She had the mumps as a kid and doesn't remember much about it, but discovered it wasn't it because she was able to drink milk. States she drank milk and was able to eat and drink. States it is concentrated around her left ear and sometimes aggravating to swallow, push something below her jaw bone and shoots pain into her ear. When probed for outcome she stated she was extremely tired the other day but got enough energy to vacuum and wash the dishes, but took about 3 naps a day for two days after that. pain- Stated initially she has taken Advil for the pain in the jaw. However, it does not phase it. She is not really supposed to take it, but didn't do anything when she took it a couple of times, so she thought maybe she just should not take it. States the pain is the same as it was yesterday and the day before. Confirmed outcome as persisting. Prenatal vitamin Caller states it was normal over the counter. States it is Vitamin A 4000 IU, Vitamin D 400 IU, Vitamin E 30 IU, Thiamin 1.8 mg, Riboflavin 1.7 mg, Niacin 20 mg, Vitamin B6 2.6 mg, Folic Acid 800 mcg, Vitamin B12 8 mcg, Calcium 200 mg, Iron 28 mg and Zinc 25 mg. Caller states she was taking Tylenol and Advil for pain. She took Tylenol this morning but can't say it's done anything yet. She clarified the Tylenol is 500 mg Equate Tylenol, it did not seem to be working, she took it two hours ago. Patient didn't remember a lot of it, we're like that, she can't concentrate, around in her ear, where you know TMJ is, and it hurts to her my mouth really wide sometimes, it bothers to swallow and she can push on a she did not know what it was the spot below your jaw bone in your neck and it shoots up the pain in my ear and she just wonder, and she know, Consumer further stated, 'Yes, just actually feeling unwell.' Consumer was informed about the department: consumer stated, 'Yes she thought she was talking to some one. she was told to hold on the line.' At site of vaccination: consumer stated, 'Left shoulder muscle at the top.' Probed for any Medical conditions or Concomitant medications. Outcome of the event messed with her TMJ on the left side was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-25 | weakness |
my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not w...
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my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it. My auntie, passed away the next two days after she got her Pfizer Covid vaccine. My auntie, who is 65 years old, got her Pfizer vaccine the the morning of April 22 2021. She told us he was completely find on the day of the vaccine. But the next morning around 9 am, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced right after midnight at 12:04 April 25th. The reported death reason is due to Bowel Ischemia with Perforation and it has nothing to do with Pfizer vaccine that she got. But I believe it is her post Pfizer covid vaccine reaction that result in Bowel Ischemia with Perforation. My auntie lived with a very healthy life style. She walked every morning, and has a shorter walk in the evening. She has no blood pressure, no blood sugar, everything is fine with her medical check. My auntie had a kidney transplant 20+ years ago and she is on the track for monthly doctor visit. When she asked her general doctor if she could get the vaccine, her general doctor asked her to consult her kidney doctor. She then went to ask her kidney doctor and her kidney doctor call her general doctor to discuss her health conditions. Both of her doctor decided that she could take the vaccine and one of the doctor registered her for the vaccine on April 15 2021. The she nurse told her to came in for vaccine on Apr 22, and she is now death after the Pfizer vaccine. I only read about people with recent organ transplant is not recommended to take the Covid vaccine. But there is no information about people that ever had kidney transplant shouldn?t take the vaccine. My auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it without a clear explanation. I would like you to contact health department to follow up on this case and find out the real root cause. If the vaccine is not recommended for people that ever got kidney transplant, CDC should publish the information so that there won?t be more victims. Please take necessary action ASAP. Thank you!
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| 64 | 2021-04-27 | unresponsive to stimuli |
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ...
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? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
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| 64 | 2021-04-30 | burning sensation, electric shock sensation, hot flush |
body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart...
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body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer
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| 64 | 2021-04-30 | nerve pain, discomfort, difficulty speaking, electric shock sensation |
she has been having some sore throat or tightness of the throat issues that she felt should be looke...
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she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she feels like her voice is getting either strange or raspy or something and had worsened; events are getting worse/Feels like she is going downhill/debilitating; Discomfort; She is in pain constantly and is scared and had worsened; Burning skin; She is in pain constantly and is scared and had worsened; electrical sensation/electrical sensations on most of the left side of the body and had worsened; severe neurological burning pain and getting worse; She can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 08Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 64 years) for covid-19 immunisation. Patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Feb2021 for covid-19 Immunization Batch/lot number EN9804, as single dose into right arm. Medical history included hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date, skin burning sensation and paraesthesia from an unknown date following unspecified brand shingles vaccine following first dose, Lot/NDC/Expiry: unknown. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication and flecainide acetate (FLECAINIDE ACETATE) taken for an unspecified indication. The patient experienced severe neurological burning pain and getting worse (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she has been having some tightness of the throat issues that she felt should be looked at (medically significant) on an unspecified date with outcome of unknown , she is in pain constantly and is scared and had worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , electrical sensation/electrical sensations on most of the left side of the body and had worsened on 08Mar2021 23:00 with outcome of not recovered , she has been having some sore throat that she felt should be looked at on an unspecified date with outcome of unknown , burning skin on 08Mar2021 23:00 with outcome of not recovered , she feels like her voice is getting either strange or raspy or something and had worsened on an unspecified date with outcome of not recovered , she is in pain constantly and is scared and had worsened on 08Mar2021 23:00 with outcome of not recovered , and discomfort (discomfort) (non-serious) on an unspecified date with outcome of not recovered. The events are getting worse/feels like she is going downhill/debilitating and she is not recovered. She has been trying to get help for these events for about a month, but events are getting worse and no one seems to know what to do. Therapeutic measures were taken as a result of she is in pain constantly. She has seen several doctors and no one can seem to help her. She is trying to get into a neurologist as referred by caller's primary care physician, but the neurologist can't see her for 5 weeks. She was seen in the hospital emergency room last night, 13Apr2021 but not admitted to the hospital. No one there seems to know what to do. ER did some blood work which turned out fine in the hospital and put her on Gabapentin. They told her to take Gabapentin 300mg 3 times daily for 2 weeks. She mentioned that next Tuesday, 20Apr2021 they are sending her in for a thyroid ultrasound but that was at her own request. Blood work done in the hospital on 13Apr2021 came back fine. The patient is not in a study or programme. No additional vaccine was administered on same date of the Pfizer Suspect. She has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-30 | pain in extremity |
soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has ...
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soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has worsened.; She believed she was injected improperly.; pain and felt that her arm has been "rendered useless".; she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back; difficulty sleeping due to the pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Lot Number: ER2613) (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing obesity. The patient's concomitant medications were not reported. The patient experienced soreness in her left arm for 2 to 3 days (on 20Mar2021) that she thought was going to get better but stated it has worsened. Caller stated that she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back. She reported difficulty sleeping due to the pain and felt that her arm has been "rendered useless". She stated that this has been ongoing for 3 weeks after her first injection. She stated that because of this, she felt like she may need physical therapy in the future. She believed she was injected improperly. She thought that happens more with people overweight, like her, because it is not quite so easy to see the muscle. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and TYLENOL, the patient stopped taking NORCO (she did not like taking it). Despite treatment, it just didn't get any better/did not work and finally she couldn't take it and she ended up going to her doctor, she was told it hasn't been verified it was an injury. The patient outcome of the events was not recovered.
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| 64 | 2021-05-03 | weakness, difficulty speaking |
Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotensio...
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Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-05-04 | pain in extremity, electric shock sensation, involuntary muscle movements |
Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down ...
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Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down to 2.5 inches by and inch.; allergic reaction; when they injected the vaccine that it burned; lethargic; half a bandage was covered in blood; it felt like three baseballs are sitting on her arm.; The muscles were so tight in her ribcage that she couldn't take a deep breath.; She states that the front of her shoulder, the sides, and the back of her arm was all hard and tense.; teeth chattered after getting the vaccine; Dizziness; difficulty breathing/hard time breathing; headache; fatigue; can still feel where the injection went; feels like an electrical shock; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; itching; muscle aches; joint aches; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; arm pain that radiated under her arm to her rib cage; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; hit a nerve upon vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), dose 1 , single dose via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included hypertension from an unknown date and unknown if ongoing History: Caller states that she does have health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic, diabetes mellitus from an unknown date and unknown if ongoing History: She has health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic. Hostorical vaccine included tired when she gets flu shot and got the thing where she couldn't lift her arm up and it hurt down the ribcage; still hurts in the lower quarter along the back side of the rib cage; still tender and goes to the bottom where the rib cage ends when she got the pneumonia shot . She is not sure if it effects the lungs more. The patient had no family history relevant to the adverse events. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient experienced kidney infection, urinary tract infection (UTI), itching all over and that lasted two days and didn't get hives, muscle aches and in the beginning she couldn't get out of bed, fatigue, arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting, hurts down her arm, nerves were jerking, feels like an electrical shock in her, would feel like her eyebrow or her nose would twitch in the center; it was so bizarre, starting at her temple going down throughout her body to her arms and fingers, it was jerking like lightening fire, the jerking started at the temple on right side and went down the face, it made her knees and ankles jerk, her arm was jerking, she still has some jerking in her left hand so it jerks over to the thumb, she can't control that, the nerves were doing their own thing, her leg and knee would move with out her wanting it to, that the moving is still happening in her shoulder, arms, knees, leg, and foot and joint aches, they hit a nerve upon vaccination and can still feel where the injection went on 27Mar2021, headache and difficulty breathing/hard time breathing and changed her position to sitting up more than laying down on 28Mar2021, dizziness on 29Mar2021, really tired for a good week and a half, size of her arm at the injection site is down to 2.5 inches by and inch, arm felt like it was big in the front, on the side and the back, it felt like three baseballs are sitting on her arm, allergic reaction, it burned when they injected the vaccine, more lethargic than normal on an unknown date. It was also reported that she had difficulty breathing, described as tightness around her rib cage on day 3 and was having a harder time breathing when laying down on day 2.5-3. She states that it still hurts down her arm. It took 4 days for her to be able to lift her arm to her head. She didn't want to lift up because it was still tender around the chest area, especially on right side. it was still tender around the chest area, especially on the right side. The muscles were so tight in her ribcage that she couldn't take a deep breath. On an unknown date, half a bandage was covered in blood and the front of her shoulder, the sides, the back of her arm was all hard and tense and teeth chattered after getting the vaccine. There was no laboratory tests performed. Treatment was received for difficulty breathing/hard time breathing and fatigue. She used her inhaler for her breathing and took ibuprofen (ADVIL, lot: RA467, expiration date: Jul 2022) liquid gel minis at night for her pain. She was prescribed cephalexin. She had an albuterol inhaler on the 28th, 29th, 30th, and 31st, so she took that treatment for 3 days. She was only trying to use one dose of the albuterol inhaler because it can raise the blood pressure, but she also wanted to breathe easier. The muscles were so tight in her ribcage that she couldn't take a deep breath. She still has that in the right lower quarter from her back side ribcage under the arm to the side of the leg. The events did not require emergency room or a physician's office visit. The clinical outcome of Itching was recovered on 29Mar2021 and dizziness was recovered on 30Mar2021, headache recovered around 31Mar2021, unknown for her leg and knee would move with out her wanting it to, felt like three baseballs are sitting on her arm, hit a nerve upon vaccination, half a bandage was covered in blood, kidney infection, urinary tract infection (UTI), fatigue, tightness around her rib cage, size of her arm at the injection site is down to 2.5 inches by and inch, allergic reaction, injected the vaccine that it burned and lethargic and recovering for muscle aches, joint aches, difficulty breathing/hard time breathing, pain in arm, nerves were jerking and feels like an electrical shock, arm pain that radiated under her arm to her rib cage and the front of her shoulder, the sides and the back of her arm was all hard and tense.
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| 64 | 2021-05-04 | pain in extremity |
Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fe...
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Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fever/chills,headache My left arm became very painful immediately after injection(the injection didn't hurt,it was after needle removed & she was getting bandage), then I started to feel lightheaded & disoriented and trouble breathing and Blood pressure elevated but it was very low immediately after injection. Didn't start feeling well until more than 2 wks after shot.
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| 64 | 2021-05-06 | breast pain |
right breast pain; Shoulder pain; can't move shoulder/ can't move her arm/ her shoulder is immobile;...
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right breast pain; Shoulder pain; can't move shoulder/ can't move her arm/ her shoulder is immobile; Shortness of breath; Anxiety; breast is hard; shoulder pain was going down her back to the trapezius/ all the way to the back; This is a spontaneous report from a contactable nurse, the patient. This 64-year-old female patient reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: ER8731) via an unspecified route in the left arm on 18Apr2021 at 12:15 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included tick bite, blood pressure, nerve pain, gastroesophageal reflux disease (GERD), and sciatica. The patient had no family history. The patient had no other prior vaccinations (within 4 weeks) of the COVID vaccine. Ongoing concomitant medications included olmesartan for blood pressure, duloxetine for nerve pain, omeprazole for GERD, famotidine for GERD; all taken for years, meloxicam for sciatica taken for 2 months and ongoing and doxycycline from 16Apr2021 and ongoing for tick bite (reported that she kept forgetting to take it). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) on 28Mar2021 at 12:00 in the left arm as a single dose for COVID-19 immunization. That dose went in the deltoid and she had no issues. Then she received the second dose on 18Apr2021 at 12:15 in the left arm. She believes it was administered in the soft tissue behind the deltoid. She noticed the person who gave the injection went behind the muscle toward the back of the arm. The next day after the second dose, she felt fine. Then the second morning it felt as if her shoulder was dislocated; and her breast is hard and painful; and she can't breath. She called her doctor who said that was not a common side effect but she stated she knows it is a side effect. The doctor recommended she go to the ER but patient didn't want to go. She stated that she doesn't know if missing the muscle is going to let the medication absorb or if it has penetrated the soft tissue. The clinical course of events was further described as follows: On 20Apr2021 at 08:00, the second morning, she woke up and felt severe pain in her right breast and shoulder all the way to back; adds she can't move her arm and her breast is so painful she can't touch it and her shoulder is immobile. She is also having very bad shortness of breath, adds she thought that may be from anxiety; so later in the day she took a alprazolam (XANAX). She added that she put up with the pain all morning and thought maybe she was working herself up so she took one half of a Xanax to calm down, to see if it was just anxiety but the shortness of breath and pain were still there. She reported she was continuing to feel all of these effects at the same level. She doesn't want to go to the ER because of the expense. The shoulder pain was going down her back to the trapezius. She clarified that she can move her shoulder and her arm, but the pain was so breathtaking that she doesn't move it and she has her arm in a sling. There were no relevant tests performed. The clinical outcome of the events right breast pain, breast is hard, shoulder pain, shoulder pain going down her back, shortness of breath, can't move shoulder/arm/ shoulder is immobile, and anxiety was not recovered. The patient mentioned that she doesn't know if not getting the shot in the deltoid caused her symptoms or not.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-05-07 | weakness |
feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous...
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feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.
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| 64 | 2021-05-10 | hot flush |
dizziness; hot flashes; This is a spontaneous report from contactable nurse reported for herself. A ...
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dizziness; hot flashes; This is a spontaneous report from contactable nurse reported for herself. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 06Apr2021 16:30 as 1st dose, single for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) were none. Medical history included breast cancer (2 Time Breast Cancer Survivor). Family Medical History included her brother is a prostate cancer survivor and it came back twice, her sister is a breast cancer survivor, and her mother is breast cancer survivor. Concomitant medications included fulvestrant (FASLODEX) (H2 receptor blocker) on 23Mar2021. Historical vaccine included hepatitis vaccine she had 10 years ago for immunisation, she did not seroconvert. She just retested 4 months ago, and she never got any antibodies from the vaccine. She did it twice at different intervals. The patient experienced dizziness (medically significant) on 09Apr2021, hot flashes (medically significant) on 09Apr2021. The event clinical course was as follows: Sometimes at night she was like a heater. States she didn't have hot flashes before the vaccine, she hasn't had them in 20 years. No treatment was received, she just deals with it. The patient started as short waves of dizziness lasting 1-2 minutes. There was no AEs required a visit to emergency room or physician office. The patient was due to get her vaccine but was not sure if there were side effects when taking fulvestrant and the vaccine together. Outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event hot flashes and dizziness cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-05-12 | pain in extremity |
arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back an...
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arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back and thigs; constriction of the windpipe; This is a spontaneous report from a contactable consumer who reported for herself. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the age of 64 years, on 09Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included back pain, fibromyalgia, restless legs syndrome, depression from 1987 to an unknown date, headache, hyperthyroidism. Concomitant medications included gabapentin (GABAPENTIN) taken for restless legs syndrome, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for depression, start and stop date were not reported; methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPIRAMATE) taken for headache, start and stop date were not reported and apixaban (ELIQUIS) taken for an unspecified indication from Feb2021 to an unspecified stop date. The patient received first dose of COVID vaccine BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced hives on legs, top of the arm and swollen lips/lip swelled really big. The patient stated, "I have had both shots of the COVID Pfizer and that the first time I had it, I had some symptoms about a little over a week out. What I had was hives. It is not that real big. This time, I have been about a week out. I was starting to have have hives and I keep having them. They are not just complete blocks just all over but spreaded and I am having kind of constriction of my wind pipe also (14Apr2021). Is that a symptom to that with the COVID virus, the shot. Yes, last I had was April 9th and I am still having spots coming out of me and I am taking Benadryl like crazy and today I have still got them on me, you know the spots and I have like something is cutting my wind pipe off, you know, constriction, you know it's not all the time but its quite a few times a day on that and I am wondering if that. When I started having the problem. The first vaccine I had on night on March 19th and about a week and a half, I had about, I would say 8 to 9 days after that. I started having the hives and then I had a real bad frozen layup out of that (further not clarified) but the second time I had the vaccine also the night and I had the hives about a week out and then I have had constriction of the wind pipe that just completely chocked me out." The patient stated that after the second dose she had arm soreness, tiredness, hives that is getting worse on legs, stomach, breast, on head, arms back and thigs and constriction in the wind pipe. She took Benadryl and Phenergan for it. Therapeutic measures were taken as a result of constriction of the windpipe and urticaria. The outcome of the event constriction of the windpipe was not recovered while other events were unknown.
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| 64 | 2021-05-13 | tenderness |
urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shing...
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urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shingles rash; the vaccine stung when it went in and the site was tender; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 23Feb2021 at 12:00 (Batch/Lot number: EL9269) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included pain, eye condition, Prediabetes, immunosuppressive - she is also taking immunosuppressive medication that is lowering her immunity: Mycophenolate since Dec2020. She also had a pain in her lower back on about 19Feb2021. Concomitant medications included prednisone (PREDNISONE) taken for eye condition from Aug2020 and ongoing-her immune system is attacking her retina, started a high dose in Aug2020 and has titrated down since then; mycophenolate mofetil (MYCOPHENOLATE) taken for eye condition and immunosuppressive from Dec2020 and ongoing; metformin (METFORMIN) taken for Prediabetes from an unspecified start date and ongoing and been on it about 6 years; and gabapentin for pain. The patient developed shingles on 03Mar2021. She is on prednisone, mycophenalate, and pain medications. She wants to know if it's ok to get the second dose since she is immunosuppressed. The patient was calling about the Covid-19 vaccine and reported that she got the first dose on 23Feb2021 and about 3.5 days later she got a shingles rash. She wanted to know if it is ok to get the second vaccine or if that is contraindicated. The patient said that she is also taking immunosuppressive medication that is lowering her immunity (Mycophenolate) and she has been on it since Dec2020. The patient said that she was on another immunosuppressive medication before this for a month that she had a reaction to. She said that was when she was switched to Mycophenolate. The doctor had her on an antiviral for shingles rash that she started on 03Mar2021. She clarified that it is Valacyclovir HCL 1 pill 3 times a day for 7 days, and she was given pain medicine called Gabapentin 100mg 1 pill 3 times a day by mouth. Her next dose of the Covid-19 Vaccine was scheduled for 16Mar2021. The patient said that the vaccine stung when it went in and the site was tender. Her arm is still a little tender at the site. She said that it seems since she has the shingles stuff it is a little tender. The patient said that she had a pain in her lower back on about 19Feb2021. She went to the doctor on 01Mar2020 because it was not going away. The doctor thought it was a urinary tract infection and gave her an antibiotic that she stopped on 04Mar2021 after being diagnosed with the shingles. The event shingles / shingles rash required a visit to Physician Office; she did a telehealth visit with her doctor for her shingles rash. The event shingles / shingles rash had not resolved while the outcome of the rest of the events was unknown.
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| 65 | 2021-01-03 | unresponsive to stimuli |
Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by ...
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Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue
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| 65 | 2021-01-04 | pain in extremity |
She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose sto...
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She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.
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| 65 | 2021-01-05 | pain in extremity, tingling |
After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling...
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After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.
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| 65 | 2021-01-05 | pain in extremity |
stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is...
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stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 65 | 2021-01-06 | pain in extremity |
Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient...
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Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-01-07 | feeling hot |
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th...
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Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 65 | 2021-01-07 | tingling, tingling |
Sxs 5 minutes post vax with tingling in LUE, but vaccine given in RUE. Tingling is persistent. No ...
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Sxs 5 minutes post vax with tingling in LUE, but vaccine given in RUE. Tingling is persistent. No improvement. Persistent sxs.
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| 65 | 2021-01-07 | pain in extremity |
my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swe...
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my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; Lymphadenopathy under both arms, red, swollen; the shoulder was swollen and the clavicle area was also swollen; sore arm; It was red like a bubbly rash like a size of pea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 17Dec2020 17:00 at single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia. Concomitant medications included lisinopril, amlodipine besilate (NORVASC), ezetimibe (ZETIA), rosuvastatin, fexofenadine, ergocalciferol (VITAMIN D), vitamin a [retinol], vitamin c [ascorbic acid], tocopherol (VITAMIN E), thiamine (VITAMIN B1) , vitamin b2 [riboflavin], niacin, vitamin b6, folic acid, cyanocobalamin (VITAMIN B12) , biotin, pantothenic acid. Registered Nurse stated, "I received the first dose of Pfizer vaccination on Thursday, 17Dec2020 at 5 PM. I began to have an adverse reaction on Friday, 18Dec2020 at 11 PM and then until the Saturday, 19Dec2020 until after dinner I had (Incomplete sentence). You want me to break it down like what the time and what the affect was? Okay 11 PM on Friday 18th my hands swelled up, they were red and they were itchy. I couldn't get the itching to stop. Hand cream or cold water they finally subsided with cold water and I was able to get sleep. Then I woke up Saturday, 19Dec2020 at 6 AM then was my hands, my feet swollen, red and itchy. Itching was just like, I did not know what to do about it. Used cold water and that rested for about 4 hours. After that stopped I had a rash on my arms, my leg and my abdomen and it just came out of nowhere. It was red like a bubbly rash like a size of pea. You think I looked at I thought what I was going to do. I went I got a cool shower another 4 hours that subsided not completely but enough where it wasn't scary anymore, it was bearable. Closer to dinner time I had Lymphadenopathy under both arms, red, swollen then I took another 4 to 5 hours to subside. During this I have sore arm that was slightly swollen. The arm was swollen, the shoulder was swollen and the clavicle area was also swollen and that's my reaction. I work in healthcare and I was just at a point I went to work, I reported the incident and I filed a VARIS report. I talked to my administrator she said I should call Pfizer, let them know. I spoke to my primary doctor, to let him know. I just wanted to report this to someone."Registered Nurse stated, "My work place. It was offered in '(Name)' hospital (not clarified)." Treatment: Registered Nurse stated, "I took Tylenol. I took it three times and that would have been a '1000 mg' each time (Not clarified)."When probed for the Causality, Registered Nurse stated, "Yes." The outcome of the events was unknown.
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| 65 | 2021-01-07 | tremor |
shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contacta...
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shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020. Information on lot/batch number has been requested.
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| 65 | 2021-01-08 | tingling |
Approximately 55 mins after vaccine was given, my lips and the end of my nose started to tingle. The...
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Approximately 55 mins after vaccine was given, my lips and the end of my nose started to tingle. The feeling intensified over 15 mins until it felt like a Novocain shot from the dentist when it starts to wear off. I took a Cetirizine 10 mg tab and the tingling completely resolved within an hour. No swelling of my mouth/ tongue or difficulty swallowing .
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| 65 | 2021-01-08 | facial pain, pain in extremity | Pain Right Arm Headache Pain r side of face and r eye |
| 65 | 2021-01-10 | burning sensation, numbness |
Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness...
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Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.
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| 65 | 2021-01-10 | tenderness | Swollen neck starting below right ear down jaw line. Tenderness and full feeling |
| 65 | 2021-01-10 | feeling hot, pain in extremity | Symptoms started on 1/16/21 with redness, swelling, pain, warm to the touch, spreading down arm. |
| 65 | 2021-01-10 | numbness |
approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in he...
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approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in her throat, and slight difficulty breathing. She self administered her albuterol inhaler, and was started on O2 AT 4 L.at 10:16 she said that the symptoms were all gone. at 10:24 she said her throat tightness had returned, she was offered benadryl and epinephrine which she refused bc she said she had to drive home. she took benadryl po when she got home.when she got home, the left side of her face became numb, she had a headache and burning eyes. The next day she still had a little numbness on the left side of her mouth. no problems since.
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| 65 | 2021-01-11 | pain in extremity |
Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night...
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Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night/Her lower back hurts; Her neck is really bad; Her hands hurt; mild arthritis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration in left upper arm on 30Dec2020 15:20 at single dose for covid-19 immunization in hospital and vaccine was not administered at Military Facility. Medical history included car accident where she broke her neck, usually she is hot all the time, she is a health person and she went the whole year without a cold. There were no concomitant medications. Prior vaccinations included regular flu shot, but she thought it was longer than 4 weeks. There was no vaccines was administered on same date of Pfizer bnt162b2. The patient clarified the side effects she was experiencing as: joint pain, muscle pain, occasional headache, and chills that were coming in and out. The patient explained she got the vaccine on 30Dec2020. The patient started to have the joint pain 3-4 days after getting the vaccine in Jan2021. She stated it was still uncomfortable. Her back hurts, especially at night. It was like all the time, but more so at night. Her neck was really bad. Pretty much every place she had mild arthritis she hurt. She felt it mainly in her neck. She mentioned historically she was in a car accident where she broke her neck. The pain in her neck was almost to the point where she was when she was initially healing from the accident. Her hands hurt. Her lower back hurts. Her knee really hurts. It all hurt more than normal. The muscle pain started 3-4 days after she got the vaccine in Jan2021. The muscle pain was sporadic. She would feel it a little bit and then it went away and then she would feel it again. The headache started within the last 2-3 days in Jan2021. She thought it had gone away for the most part. She just got an occasional headache when her neck hurt a lot. It kind of went with the neck hurting. The chills started around 02Jan2021 or 03Jan2021. Usually she is hot all the time. However, lately she had been feeling chills. She was not sure if it was due to weather or if she was really having chills. This is unusual for her. She stated the chills was kind of the same or maybe a little better. She had a COVID test done on 26Dec2020 which was negative. She had to have the test done for pre-surgical reasons. The adverse events did not require a visit to emergency room or physician office. The outcome of joint pain/knee really hurt, muscle pain and chills were not resolved, outcome of rest events were unknown.
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| 65 | 2021-01-11 | tingling | Palm tingling enough to wake from sleep Sore arm Site injection pain |
| 65 | 2021-01-12 | facial paralysis, hot flush |
Patient states that a couple of minutes from receiving the vaccine she got a hot flash. About 10 min...
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Patient states that a couple of minutes from receiving the vaccine she got a hot flash. About 10 minutes after the vaccine the patient states that her mouth and face started drooping on left side. She took a drink and it felt weird.
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| 65 | 2021-01-12 | tingling |
lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after t...
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lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after the second vaccine and she is afraid; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular (left arm) on 06Jan2021 at single dose for covid-19 immunisation. Medical history included blood pressure (abnormal) and blood cholesterol (abnormal) from an unknown date. Concomitant medication included lisinopril (LISINOPRIL) for Blood pressure for 3 years and adenosine (TRICOR) for cholesterol for 6 months; from unspecified dates and ongoing. On 06Jan2021, 50 minutes after the dose, her lips and nose were tingling described as tingling like when a dentist puts your mouth to sleep. It lasted about an hour. She took Cetirizine which she is sure helped. Within the hour of taking Cetirizine it was gone/resolved. She is afraid for the second vaccine. She has heard that you feel sicker after the second vaccine and she is afraid because it is her mouth. She also stated she took Ibuprofen an hour before hand to ward off evil (as reported). She took 400 mg. She asked if there is information on tingling and if it would be worse after the second dose. Outcome of the events lips and nose were tingling was recovered while unknown for "She has heard that you feel sicker after the second vaccine and she is afraid". Information about batch/lot number has been requested.
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| 65 | 2021-01-14 | flushing |
Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 min...
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Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
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| 65 | 2021-01-14 | weakness | Tempature, body aches and feeling weak |
| 65 | 2021-01-15 | pain in extremity | LEFT ARM SORENESS AND NECK PAIN. |
| 65 | 2021-01-17 | pain in extremity |
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccinatio...
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Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination. States she had these same symptoms up to 3 days after vaccine but they resolved. She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
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| 65 | 2021-01-17 | tremor, weakness, feeling cold |
TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND S...
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TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND SHAKING. TOOK TYLENOL SINUS. REPEATED TYLENOL SINUS EVERY 4 HRS FOR HEADACHE. ON SAT AND SUNDAY WAS WEAK--MONDAY FELT BETTER.
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| 65 | 2021-01-17 | pain in extremity, weakness |
chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous repo...
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chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.
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| 65 | 2021-01-18 | feeling hot, feeling of body temperature change, pain in extremity |
was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a sponta...
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was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization, in the hospital. Medical history included blood pressure high and high cholesterol. The patient reported "I just got my second Pfizer Vaccine (clarified as BioNTech Covid 19 vaccine) yesterday (07Jan2021) and I just wanted to call to report the side effects that I have because they told me you should specially after the second one. And I have had fever, headache, and chills. So, I just wanted to report this". When asked about the event start date, the patient stated, "I went to sleep, I got the shot yesterday morning on early (07Jan2021). And then I was fine except for the sore arm. And then I woke up in the night. I fell asleep fine; I woke up through the midnight and it was burning up. So, I took my temperature. So, I'd say about 3 am (08Jan2021)". When asked if the patient was still experiencing the events, the patient stated, "Little bit because I had also throbbing headache and I was hot, I was cold. I did take Tylenol (treatment) and I did think that it started to help a little bit. Because I did got, my fever has gone down." The outcome of the events was recovering.
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| 65 | 2021-01-19 | feeling hot | Felt hot; chest tightness; nausea; metallic taste in her mouth |
| 65 | 2021-01-19 | feeling cold |
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head...
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passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-01-20 | flushing |
Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient). A ...
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Flushed face; Severe nausea; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included hypertension and gastrooesophageal reflux disease. The patient previously took lisinopril and experienced drug hypersensitivity and anaphylactic reaction, diphenhydramine (BENADRYL) and experienced drug hypersensitivity and urticaria. Concomitant medication included propranolol hydrochloride (PROPRANOL), chlorthalidone (unknown manufacturer), rabeprazole sodium (ACIPHEX), vitamin c (unknown manufacturer). The patient experienced flushed face and severe nausea on 11Jan2021 13:00 with outcome of not recovered. It was unknown f treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the Batch/Lot number has been requested.
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| 65 | 2021-01-21 | difficulty speaking |
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; ...
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Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
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| 65 | 2021-01-21 | pain in extremity | Arm soreness developed morning after vaccine, still present on D2 |
| 65 | 2021-01-21 | flushing, tingling |
Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in...
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Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in my arms on and off all day.
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| 65 | 2021-01-21 | weakness |
Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) ap...
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Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron with resolution of all symptoms except generalized weakness and fatigue. Workup in the ED was negative, and the patient was discharged home.
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| 65 | 2021-01-21 | weakness |
Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure ...
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Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID-19 vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron. Workup was negative, and the patient was discharged home.
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| 65 | 2021-01-21 | numbness |
Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse. Pat...
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Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse. Patient complained of tightness in her throat. Epi administered by observing nurse.
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| 65 | 2021-01-21 | migraine | Severe migraine Brain fog Lymph node under left arm is extremely painful to touch Body aches |
| 65 | 2021-01-22 | discomfort |
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and...
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Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
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| 65 | 2021-01-24 | weakness |
I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, e...
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I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, exhaustion for 4 days. shot given on Wednesday and not able to shower or get up till Sunday Second shot symptoms more severe. Headache, sick to my stomach vomited, and exhaustion same thing shot given on Wednesday and not able to get up till Sunday. First 24 hours of the second shot I was so weak I good not get up even to get a drink.
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| 65 | 2021-01-25 | weakness | About 15 hours later headaches, chills, congestion, weakness, body aches |
| 65 | 2021-01-25 | weakness | DAY AFTER VACCINATION, HAD LOW GRADE FEVER, FATIGUE, AND WEAKNESS |
| 65 | 2021-01-25 | feeling hot |
Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nausea...
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Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
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| 65 | 2021-01-25 | facial pain |
I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain...
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I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; I developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes.; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO146), via an unspecified route of administration on right arm on 23Dec2020 12:00 at a single dose for covid-19 immunisation. Medical history included hypertension, osteopenia, hypercholesterolaemia and migraine; all from an unknown date. Patient is not pregnant. The patient had her second dose of pneumonia vaccine on 01Dec2020 that was administered on her right arm for immunization. Concomitant medications included calcium, alendronate sodium (FOSAMAX), losartan, meloxicam and simvastatin; all were taken from an unspecified date for an unspecified indication. The patient previously took naproxen sodium (NAPROSYN) and experienced drug allergy. On 28Dec2020 12:00, the patient developed jaw pain and intense pain chewing on the right side for 48 hours, plus swelling and pain in the right cheek and right neck lymph nodes. The patient did not received any treatment for the reported events. The patient underwent lab tests and procedures which included covid-19: negative on 28Dec2020, on 30Dec2020, on 04Jan2021 and on 08Jan2021 (nasal swab) while on 11Jan2021 (nasal swab) had pending result. The outcome of the events was recovered.
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| 65 | 2021-01-25 | pain in extremity | Low fever, Chills, Body aches, Sore arm, Mild head ach |
| 65 | 2021-01-26 | tingling |
STATES AFTER INJECTION FELT SOME TINGLING IN FINGERS IN BOTH HANDS NO OTHER SYMPTOMS OBERVED FOR 30...
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STATES AFTER INJECTION FELT SOME TINGLING IN FINGERS IN BOTH HANDS NO OTHER SYMPTOMS OBERVED FOR 30 MINUTES DISCHARGED DENIES ANY COMPLAINTS
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| 65 | 2021-01-27 | pain in extremity |
Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas...
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Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021. It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
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| 65 | 2021-01-27 | weakness |
Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. ...
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Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
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| 65 | 2021-01-27 | weakness |
Immediately following vaccination, the patient reported dizziness, weakness, and suffered a syncopal...
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Immediately following vaccination, the patient reported dizziness, weakness, and suffered a syncopal episode. EMS recorded the patient's blood pressure at 70/60 mmHg. EMS administered IV fluids while patient laid flat in transport to emergency department. BP had stabilized in triage 136/79. Discharged home after evaluation.
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| 65 | 2021-01-27 | pain in extremity | Sore arm. body aches, low grade fever, headache, |
| 65 | 2021-01-27 | inability to speak |
she couldn't get the words out properly when speaking with a client; she was looking at her husband ...
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she couldn't get the words out properly when speaking with a client; she was looking at her husband and she couldn't see about a quarter of his face; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the upper left arm, on 05Jan2021 08:45 at a SINGLE DOSE for covid-19 immunization. Patient had no other relevant medical history. There were no concomitant medications used. Historical vaccine included Flu vaccine. On 10Jan2021 11:51, the patient experienced that when she was looking at her husband and she couldn't see about a quarter of his face. About 10 minutes later (12:01), she couldn't get the words out properly when speaking with a client. Within five minutes or so, everything was back to normal. Outcome of events was recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 65 | 2021-01-28 | cold sweat, tremor |
Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizzines...
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Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizziness, shortness of breath, nausea, shaking. patient is clammy & pale, a&o x4, lungs clear bil all lobes, pulse normal, cap refill <3, V/S @ 10:20, b/p 140/90, r22, p72, t 99.7, unable to obtain o2 stat via pulse ox r/t pt shaking. Patient states that temp normal runs 96.8. Monitoring pt while obtaining health history. 10:40 V/S t 99.8, b/p 160/74, p113, 02 88% on RA, r 24, o2 placed on pt 15l nonrebreather, o2 91%. 10:50 EMS arrived, pt a&ox4, no change in condition, V/S 100/60, 100% on 15L nonbreather, p90, r22. 10:55 still nausea, 4mg sublingual zofran given. 11:04 pt transferred to stretcher with assisit, a&Ox4, V/s 132/69, p80, 94% o2 on 10l via nasal cannula, r26 co2 33. pt transferred via ambulance, pt request to be taken to hospital.
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| 65 | 2021-01-28 | flushing |
Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine. Took be...
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Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine. Took benadryl with good effect. Symptoms completely resolved by the following morning.
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| 65 | 2021-01-28 | cold extremities |
Starting the next night my feet wer freezing when trying to lie down at night, could not get them wa...
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Starting the next night my feet wer freezing when trying to lie down at night, could not get them warm unless wrapped in a blanket which is not normal for me, still ongoing but less intensity today 1-29 Ongoing fatigue and having to nap daily and if working go home and going to be early and sleeping about 10-11 hours a night, again not normal Improving daily but still ongoing
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| 65 | 2021-01-29 | flushing | numb lips with tightness and itching in throat, flushing |
| 65 | 2021-01-30 | pain in extremity |
"Pfizer-BioNTech Covid-19 Vaccine EUA Six days after after I received the second dose of the vaccine...
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"Pfizer-BioNTech Covid-19 Vaccine EUA Six days after after I received the second dose of the vaccine I started having a right hip pain. The next day, I started having constant low back pain, bilateral hip pain, left shoulder pain and pain below both thumbs. Aleve relieved the pains only for 6 hours and then start again. My sleep was so disrupted for 7 days. I finally say Dr. on 1/19/2021
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| 65 | 2021-01-31 | pain in extremity |
Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing th...
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Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing that evening, headache, sore arm. Took Tylenol.
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| 65 | 2021-01-31 | tingling |
Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at...
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Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at the time of evaluation
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| 65 | 2021-02-01 | flushing |
Client c/o flush that washed over her while waiting 15 minutes. Also stated tachycardia and "skippe...
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Client c/o flush that washed over her while waiting 15 minutes. Also stated tachycardia and "skipped heart beats." She stated that the skipped beats started about a week after her first dose of Pfizer. BP 128/82, pulse 88 with 1 skipped beat every 1-2 minutes by palpation. She refused EMS, went home in car after 50 minutes. At 4:15 p.m. called after another episode of flushing and tachycardia, feeling "weird." Went to urgent care and had EKG, normal compared to one 2 years ago. NP and a consulting doctor diagnosed vaccine reaction, advised fluids and rest. BP and pulse continue to fluctuate. Per client, 2/2/21 a.m. her pulse goes from 80-112. She will continue to monitor.
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| 65 | 2021-02-01 | tingling |
Very strong pins/needles throughout body; This is a spontaneous report from a contactable consumer r...
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Very strong pins/needles throughout body; This is a spontaneous report from a contactable consumer reporting for self. A 65-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jan2021 (at the age of 65-years-old) 17:00 as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, arrythmia, high sugar, and penicillin allergy. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included metoprolol succinate (TOPROL), lisinopril, amlodipine, and esomeprazole sodium (NEXIUM). On 16Jan2021 at 10:00, the patient experienced very strong pins/needles throughout body. There was no treatment provided for the event. The outcome of the event very strong pins/needles throughout body was not recovered. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 65 | 2021-02-01 | speech disorder, numbness, pain in extremity |
hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in h...
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hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-02-01 | pain in extremity |
headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer report...
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headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
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| 65 | 2021-02-01 | pain in extremity | initial more pain, swelling lasting 1 week with itching, then upper arm pain shoulder pain |
| 65 | 2021-02-02 | tingling |
1. Nose felt tingly. 2. Throat started feeling weird - eventually like it was numb. 3. It felt ...
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1. Nose felt tingly. 2. Throat started feeling weird - eventually like it was numb. 3. It felt like a tingling sensation in my veins, starting in my head then throughout. This lasted a few seconds. 4. Next, I felt dizzy and could not see well. I did not get sweaty and did not faint. This lasted approximately 5 minutes.
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| 65 | 2021-02-02 | numbness | lower jaw was swollen & numb as well as my part of my nose & tongue |
| 65 | 2021-02-03 | weakness |
Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and ti...
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Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and tired. I started with a headache in the evening of 2/2/21
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| 65 | 2021-02-03 | pain in extremity |
Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a c...
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Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.
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| 65 | 2021-02-03 | tenderness |
Breakout in fever blisters all over my mouth; usually happens when my body is under stress like that...
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Breakout in fever blisters all over my mouth; usually happens when my body is under stress like that; local tenderness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EL3249), via an unspecified route of administration, on 12Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization.The facility where COVID-19 vaccine was administered was at a hospital. Medical history included pain and anxiety depression from an unknown date and unknown if ongoing. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) for pain and desvenlafaxine succinate (PRISTIQ) for anxiety and depression. On Jan2021, the patient experienced local tenderness and on 18Jan2021, the patient experienced breakout in fever blisters all over her mouth, stating this usually happens when her body is under stress like that. Therapeutic measures were taken as a result of local tenderness and breakout in fever blisters all over my mouth (anti-fever blister type medicine). The clinical outcome of the events fever blisters all over her mouth and local tenderness were unknown. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-02-03 | pain in extremity |
Got tested and came positive after receiving first vaccine; Got tested and came positive after recei...
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Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
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| 65 | 2021-02-04 | feeling cold, tingling |
About 1/2 hour of the vaccination, I felt mild tingling of the lips. Very gradually, that got worse...
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About 1/2 hour of the vaccination, I felt mild tingling of the lips. Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet. I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose). I checked my pulse ox, and it remained above 97%. I never had rash or trouble breathing. But about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving. Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips. I also felt very cold, and had a hard time getting warm. This also improved with the Benadryl.
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| 65 | 2021-02-04 | weakness |
Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shor...
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Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.
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| 65 | 2021-02-04 | pain in extremity |
a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 ...
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a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at 08:00 a single dose for covid-19 immunization. Medical history included breast cancer stage one from Oct2019. There were no allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN). The patient experienced the following event on 21Jan2021, at 03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
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| 65 | 2021-02-04 | pain in extremity |
fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous...
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fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
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| 65 | 2021-02-05 | feeling cold |
Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly ...
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Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly chilled. Next day: fatiqued.
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| 65 | 2021-02-05 | migraine |
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued ...
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Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
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| 65 | 2021-02-05 | weakness, pain in extremity |
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv...
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Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
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| 65 | 2021-02-06 | tingling |
Right side of tongue tingling and slight swelling, hives on right inside of mouth, right eye slight ...
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Right side of tongue tingling and slight swelling, hives on right inside of mouth, right eye slight swelling, right side of face tingling, and a dime sized hive on my right temple area.
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| 65 | 2021-02-07 | tremor | HA over R-eye, dizzy, shaky, no breakfast, no BS check., BS @ 14:18: 294 |
| 65 | 2021-02-07 | feeling cold |
Woke up with vertigo. Felt dizzy, nauseated and cold. Around noontime this feeling had passed, alt...
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Woke up with vertigo. Felt dizzy, nauseated and cold. Around noontime this feeling had passed, although still feeling a bit sluggish.
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| 65 | 2021-02-07 | pain in extremity |
she used to be 6'2 but she thinks she has shrunk a little; nauseous/she is still just a little queas...
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she used to be 6'2 but she thinks she has shrunk a little; nauseous/she is still just a little queasy; tried to get out of bed, and the whole world tilted on her/everything turned upside down; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 17Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included Breast cancer in 2003 or 2004, for which the patient was in three clinical trials following that time. The patient reported that she requested to have the vaccine administered into her right arm because she is a breast cancer survivor. The patient has no concomitant medications. The patient confirmed that she did not have any other vaccines on the same day as the COVID vaccine. The patient previously received Letrozole for breast cancer and provided that she has not taken letrozole or any or medications, not even vitamins, for the last three years. On 18Jan2021 the patient experienced sore arm, which was not severe per the patient. On 21Jan2021 at around 03:00, the patient was nauseous and when the patient tried to get out of bed, the patient felt like the "whole world tilted on her". The patient reported the same thing continued a few times when she tried to get up, she just couldn't because everything turned upside down. So the patient went back to sleep, and she got up at 11:00AM, and she feels much better now, and now she is just having a little bit of remaining queasiness, like she can't go on a run right now, she is not 100%. The patient inquired if these are known side effects of the product. The patient also reported that she that she used to be 6'2 but she thinks she has shrunk a little from an unknown date. The patient stated that her PCP was not aware that she received the vaccine. The clinical outcome of the sore arm was recovered on 19Jan2021. The clinical outcome of the nauseous/she is still just a little queasy, tried to get out of bed, and the whole world tilted on her, and thinks she has shrunk a little was unknown.
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| 65 | 2021-02-08 | numbness, weakness |
All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, le...
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All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered.
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| 65 | 2021-02-08 | facial paralysis |
Awoke with symptoms of Bells Palsy - droopiness on left side of face, especially mouth, unable to li...
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Awoke with symptoms of Bells Palsy - droopiness on left side of face, especially mouth, unable to lift left side
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| 65 | 2021-02-08 | cold sweat |
I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horr...
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I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horrible body pain. No temp. I missed 6 days of work I was so sick.
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| 65 | 2021-02-08 | numbness |
Numbness on left arm and fingers and pressure under left axillary. V/S 185/90 P-89, R- 18, O2 sat 99...
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Numbness on left arm and fingers and pressure under left axillary. V/S 185/90 P-89, R- 18, O2 sat 99%, no SOB. Patient observed for 45 minutes and was taken to ED for further evaluation.
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| 65 | 2021-02-08 | tingling |
Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hosp...
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Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hospital. Post dose she experienced intermittent sensation of tingling on left posterior neck area with no paresthesia and difficulty lifting bilateral extremities. Three days after administration of the vaccine she began noticing weakness in her legs that eventually progressed to her arms bilaterally. She developed pitting edema and SOB. Per infectious disease MD, the main suspicion is for GBS Guillain-Barre Syndrome given exam findings. Pt's weakness and resulting inability to ambulate may have pushed pt into CHF exacerbation. Patient received 3 days of IVIG which was discontinued due to worsening mental status. Naranjo scale score of 2 indicates possible ADR.
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| 65 | 2021-02-08 | feeling cold, weakness |
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ...
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She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
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| 65 | 2021-02-08 | tingling |
Tingling in both legs. No treatment, vitals stable. Tingling resolved after a few minutes. Also s...
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Tingling in both legs. No treatment, vitals stable. Tingling resolved after a few minutes. Also suffers from sciatica.
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| 65 | 2021-02-09 | feeling hot |
Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155...
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Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-02-09 | unresponsive to stimuli |
Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by parame...
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Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by paramedics at 06:25am on 2/5/2021.
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| 65 | 2021-02-09 | burning sensation |
Shot given 10:19pm on 2/6/21. Noticed rash on 2/8/21 11:55am. Rash was bilateral on face along mad...
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Shot given 10:19pm on 2/6/21. Noticed rash on 2/8/21 11:55am. Rash was bilateral on face along madibles from TMJ to about 1" from lips and was 2" superior from jaw line towards the eyes. Rash was very red over skin area with multiple darker spots and by 2/7/21 those spots appeared open though no blisters or pustules were seen. Rash had burning sensation which was relieved by Vaseline. Once doctor was seen (PA), Tacrolimus ointment was prescribed BID. Rash no longer burns 2/9/21 pm and it appears to be resolving. Spots are still evident but erythemic area is gone.
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| 65 | 2021-02-09 | pain in extremity |
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa...
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Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
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| 65 | 2021-02-10 | pain in extremity | Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1 |
| 65 | 2021-02-10 | pain in extremity | Sore arm nausea headaches chills fever |
| 65 | 2021-02-10 | feeling hot |
Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While...
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Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While in a store buying flowers... approximately 11:45am... experienced sudden and overwhelming onset of profuse heat and perspiration. Eyeglasses immediately fogged up, perspiration ran down my back and ran under my face mask. I felt lightheaded and faint. My husband confirmed that my back was "on fire". Last night, I was awakened by extreme chills and shivering... every muscle and joint tense and painful. This continued for some time and then I became feverish with bed cloths and bedding soaked. Had a temp of 102 @7:30 am with HA and muscle & joint pain.
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| 65 | 2021-02-11 | pain in extremity, feeling cold |
Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and di...
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Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
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| 65 | 2021-02-11 | feeling hot, discomfort |
patient felt pressure and warmth across upper body within 15 min of injection, she complained of som...
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patient felt pressure and warmth across upper body within 15 min of injection, she complained of some facial swelling, benadryl po given at site, BP monitored after 30 min observation period patient was transported to ED for facial and tongue swelling after injection
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| 65 | 2021-02-14 | tremor, discomfort, migraine, pain in extremity |
Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, feve...
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Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, fever of 101.5F followed by shaking chills,, then fever again. Experienced myalgia and severe migraine-like headache with light sensitivity. The arm pain from shoulder to mid-palm was so severe that I couldn?t lift my arm. This resolved by approximately noon on 02/10/2021. The other symptoms largely resolved by midday 02/11/2021 wit residual low-grade headache, dizziness, and unsteadiness on my feet. I woke up on 02/11/2021 around 7AM with left axillary lymphadenopathy approximately the size of a tennis ball cut in half with associated moderate discomfort. The discomfort resolved by 02/14/2021, but the lymphadenopathy remains at about half the mass noticed originally.
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| 65 | 2021-02-14 | tremor |
Hx of anxiety. Became anxious, legs shaking and felt like her throat was closing immediately after g...
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Hx of anxiety. Became anxious, legs shaking and felt like her throat was closing immediately after getting the vaccine. Pulse ox originally 91% on RA but improved to 95% on 2L. Patient fully recovered after 30 minutes with no medications.
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| 65 | 2021-02-14 | numbness and pain in extremities, tingling, burning sensation, numbness |
neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp...
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neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp burning needles sensation up arms and legs; Tips of fingers and toes were numb and felt swollen; Tips of fingers and toes were numb and felt swollen; Hands then started peeling, palms became thickened and rough; This is a spontaneous report from a contactable healthcare professional, the patient. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 22Dec2020 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included A-fib (atrial fibrillation), GERD (gastroesophageal reflux disease) and osteoporosis. Concomitant medications included atenolol, calcium, acetylsalicylic acid (ASPIRIN), famotidine (PEPCID) and omeprazole. Past drug history included known allergies: fexofenadine (ALLEGRA) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Dec2020, day 4 after injection, the patient experienced heat sensitivity in hands and feet, followed by tingling in hands > feet, with sharp burning needles sensation up arms and legs. Heat sensitivity continued. Tips of fingers and toes were numb and felt swollen for several days, while neuropathy continued. Hands then started peeling, palms became thickened and rough. For the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling an emergency room visit and physician office visit was required. Unspecified treatment was provided for the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling. The outcome of the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling was recovering. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab on 13Jan2021 was negative and on 19Jan2021 was negative. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropath, cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-02-15 | tingling |
After client received vaccine client states she has tingling in her fingers, pain in both sides of l...
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After client received vaccine client states she has tingling in her fingers, pain in both sides of lower neck, dry mouth. Vitals obtained by EMS O2 sat 99%, BP 168/87, Pulse 100. Client states she is feeling better. Client discharged home. Client advised to call if symptoms return.
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| 65 | 2021-02-15 | tenderness |
Bone directly in front of right ear, as well as the space between the bone and the ear, are tender t...
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Bone directly in front of right ear, as well as the space between the bone and the ear, are tender to the touch. Lower jaw out of whack with upper one, which affected teeth alignment. Painful to open mouth. Much better by Monday. The area by the ear is not nearly as sensitive to the touch, on Tuesday it's gone, but the jaw still doesn't feel normal.
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| 65 | 2021-02-15 | numbness |
Patient received first dose of the COVID vaccine and was monitored for 30 minutes, felt fine at that...
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Patient received first dose of the COVID vaccine and was monitored for 30 minutes, felt fine at that time and was allowed to leave. Approximately one hour after receiving the vaccine patient experienced right side of neck and face up to eye becoming numb and tight. Tongue got a little numb also. Over the next two hours the symptoms lightened up and by morning just felt like she had a numbing agent at the dentist along right lip, nostril and check.
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| 65 | 2021-02-15 | pain in extremity |
She was eating after the vaccine which started as a stiffness, down both of her shoulders and into h...
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She was eating after the vaccine which started as a stiffness, down both of her shoulders and into her waist, severe nauea and headache. She felt like her feet were in cinderblocks. She took some Tylenol, and woke up at 4:00 AM and had two severe headaches and nausea since Sunday. That night she felt as though she could not stand it any longer. Went to UC and they tested her for the virus which was negative, and still having symptoms. She thought the symptoms would get less, but it has been quite a few days. She takes a short walk and the intense pain in her arms, and legs are terrible. Her PCP told her that there was nothing they could do, and what she had been doing what she needed to do. They also told her to go back to UC if she did not improve.
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| 65 | 2021-02-15 | pain in extremity, weakness, feeling cold |
Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, uppe...
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Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, upper body shoulders to wrists aching. Weakness of upper extremities. 2\16\2021 generalized weakness fatigue,Felt cold, discomfort to skin during shower from water pressure. Difficult getting dressed/ stiffness. Tylenol 500mg q6 hrs and rest all day TX. Feeling better by 4 pm
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| 65 | 2021-02-16 | pain in extremity, nerve pain |
About 10 hours after vaccination a headache started. Then my joints started hurting almost like a ne...
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About 10 hours after vaccination a headache started. Then my joints started hurting almost like a nerve was firing off but only at the joints, ie knee, shoulder, toes, ankle, fingers, toes, etc. It would happen randomly. Never all joints at once. Very weird. Continued throughout the night making it difficult to sleep. In the morning, at 7 am, got up out of bed. Took 2 Advil. At 10:20 I still have the joint happening but not as frequent and not as strong. I still have the headache. It hasn't changed.
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| 65 | 2021-02-17 | migraine, weakness |
trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feelin...
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trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer. A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat. Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
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| 65 | 2021-02-18 | weakness, pain in extremity |
1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head whic...
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1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head which then continued to a pain in my neck. also left side, then back pain, then slightly short of breath. I remained in the waiting area for over a half hour and felt no worse, but did report it to the young woman at the exit who said that was odd and seemed the kind of response with the second dose. I presumed it might be due to my already having antibodies. As I continued my day those symptoms quickly dispersed and I felt fine, albeit with a light soreness at the site on my left arm. At approximately 6pm I felt very fatigued and rested until 10pm, when I began to have chills, a headache and nausea. My left arm was also so sore I could not lay comfortably. I took Tylenol and aspirin both at 11:30 pm and attempted to sleep, which was fitful and disturbing. I had strange neurological events, such as odd visions in my half sleep and bizarre semi dreams but could not waken. At 4:00 AM I finally was able to pull out of this state and the last thing in my mind was a conversation with someone trying to explain what was happening to me, in my mind not vocal, that was in Italian. That is my second language. All day I had unwanted words, ideas etc. floating about in my brain. I could no longer sleep and was very weak, had terrible head and body aches and my legs also ached terribly. I was also slightly nauseous.These were all symptoms, minus the disturbing neurological one, that I had with Covid. I was too weak to leave the bed until much later in the day. I am still having effects but much less and I am at the 72 hour mark. I remained at rest all day and ran a low fever, then again a fever
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| 65 | 2021-02-18 | pain in extremity |
Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vac...
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Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vaccine: muscle aches, hand/wrist swelling and pain, and diahrrea on day 13. This has lasted 3 days and has started to subside with the use of ibuprofen every 4 hours. Reported to Dr. on Day 12.
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| 65 | 2021-02-18 | tremor |
Dizziness started early afternoon and got worse thru evening, when nausea began. At about 11:00 PM,...
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Dizziness started early afternoon and got worse thru evening, when nausea began. At about 11:00 PM, I vomited 4 times. After that, shaking chills set in. I did not take anything for it. When I woke up the next morning, I felt fine.
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| 65 | 2021-02-18 | feeling hot, tingling, weakness |
Extreme dizziness Diarrhea Dry heaves Tingling in arms and legs Extremely weak Chills and hot Hus...
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Extreme dizziness Diarrhea Dry heaves Tingling in arms and legs Extremely weak Chills and hot Husband cared for me. Spoke to nurse at my doctor?s office. Water. Eventually bland food. Condition improving. She told me to go to ER if extreme dizziness recurs.
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| 65 | 2021-02-18 | weakness |
I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went...
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I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went back to bed. For the rest of the day I experienced: Feaver 102.4 Feaver 100.6 Severe vomiting 3x chills sweats body aches pain behind my eyeballs headache extreme weakness I continued to rest and take Tylenol all day to break the fever. The next morning, 2/17/2021 I woke up with a fever of 100.4 and took Tylenol. All other symptoms were gone by 2/17 except for low grade fever and fatigue. Fatigue continues still as of this reporting 2/19/21
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| 65 | 2021-02-18 | flushing |
Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after admi...
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Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after administration of COVID vaccine. Upon assessment, patient's blood pressure was 187/110. Patient began to develop rash across chest and arms. Mobile response called and patient was escorted to ED.
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| 65 | 2021-02-18 | breast pain |
Severe to VERY severe continuous lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4...
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Severe to VERY severe continuous lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4 intensity started to vary i.e no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On night of 2/3 spread to back ? shot side line of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain Pain interferes with sleep - 2/4 finally able to get 4 hours sleep ( hot shower temporary relief while showering)( normal is 7 hrs) As of 2/5 still in moderate to severe breast area pain almost continuously. Hope I am recovering but its 10 days and still mostly constant incapacitating pain. Very slight intermittent node pain by Feb 17 when got second shot in other arm per Physician Assistant?s recommendation. So far after 51 hours 2nd shot adverse effects minimal and does not interfere with thinking or sleeping
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| 65 | 2021-02-18 | pain in extremity | Very bad pain and weakness in left arm and headache |
| 65 | 2021-02-21 | pain in extremity |
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even ...
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Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.
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| 65 | 2021-02-21 | weakness |
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a...
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I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
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| 65 | 2021-02-21 | migraine | Ongoing right shoulder pain and increased migraines |
| 65 | 2021-02-21 | weakness, pain in extremity |
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness...
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all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
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| 65 | 2021-02-21 | muscle twitching, muscle spasms, tingling, burning sensation |
sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread th...
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sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; she was up all night and couldn't sleep/ restless, had trouble getting sleep, had trouble getting in a comfortable position/ woke up frequently; restless, had trouble getting sleep, had trouble getting in a comfortable position, and woke up frequently.; tightness in her left leg; weird sensations in her legs/ sensations moved to her arms; Ongoing Restasis for Sjogren's syndrome; Ongoing Restasis for Sjogren's syndrome; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: L9261) via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included ongoing Sjogren's syndrome from 2015 (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay), ongoing rosacea; dry eye syndrome (related to Sjogren's syndrome); spasming, burning and twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles); arthritis flareup from Oct2019 (in her left leg, she saw her neurologist who did tests and they came back normal) and sinus infection in 2020. Ongoing concomitant medication included ciclosporin (RESTASIS) for Sjogren's syndrome, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for blood test: deficient and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for dry eye syndrome related to Sjogren's syndrome. The patient previously took prednisone from Nov2020 and experienced weirdness in her legs got strong enough to keep her up at night and bad flare up for her leg symptoms; metronidazole for flare up or Rosacea (0.75% as needed, which she has used daily for last few weeks), meloxicam in Nov2020 and pantoprazole in Jan2021 and had bad flare up for her leg symptoms (symptoms subsided as soon as she stopped taking the medication after about 5 days); ibuprofen, acetaminophen and pepcid for her stomach. She had the vaccine, her first dose, on 27Jan2021, about a week ago. The first two days she didn't notice anything and then she had weird sensations in her legs on 28Jan2021. The second night she had a weird sensation in her legs which was similar to what she had experienced with the two medications she took in November and January. On 30Jan2021 the sensations spread through her body, she describes these sensations as twitching, burning, cramping, and tingling. She clarifies the sensations moved to her arms which did not happen with the other medications that she tried in November and January. Monday night, 01Feb2021, she was up all night and couldn't sleep and says she called the family doctor yesterday and he called in a prescription for Gabapentin 100 mg. She said she took the medication last night and she did sleep last night, but she was unsure if it was from exhaustion from the last few nights from not sleeping or the medicine, but she did sleep better and her symptoms were a lot less last night. Patient said she wanted to report this and that her concern is with the second dose; will she have a worse reaction, is there anything she can do or take and should she be concerned about it. She said the events gradually increased, they started mildly and then became significant. She felt the sensations a little bit in the day time but they start big time in the night when laying down. These sensations experienced in her legs started the second night, 28Jan2021, and then spread to her arms in the last couple of days which had not happened with her other incidences (with the medications mentioned above back in November and January). Clarified that the sensations spread to her arms on 29Jan2021, but the worst nights were 31Jan2021 and 01Feb2021. She said they were bad nights. She said in regard to her sleeping, starting on 29Jan2021, she was restless, she had trouble getting sleep and trouble getting in a comfortable position. She woke up frequently. Saturday the sleeping was a little worse, but she did sleep. She said on Sunday, 31Jan2021, and Monday, 01Feb2021, she hardly got any sleep. The sensations spread to her arms and it probably started a little on Saturday night, but Sunday and Monday it was very noticeable. She started Gabapentin; it was one a day before bed. The leg symptoms were still there last night. The sensations in her arms were not much at all. She did get up once with the leg cramp and was feeling tightness in her left leg but it never went into a cramp. The cramp was in her right leg, which was unusual because it was usually in her left leg. She stated she was unsure if her symptoms were starting to subside or if the Gabapentin had an immediate effect. The events did not require a visit to physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
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| 65 | 2021-02-21 | feeling hot, tingling |
tongue swollen, throat felt "thick, heaviness in chest, palms of hands felt hot and tingly, started ...
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tongue swollen, throat felt "thick, heaviness in chest, palms of hands felt hot and tingly, started as we were leaving the vaccination location outside the hospital about 10 minutes after the shot. No treatment.
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| 65 | 2021-02-22 | feeling hot |
78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I ...
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78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I felt hot and chilled... I am not sure it was related to the injection. It resolved on sat Feb 20th 2021. I still have mild nausea but am on Ozempic which gives me nausea some of the time. I did not feel well but finally fell asleep and slept until AM.
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| 65 | 2021-02-22 | weakness |
In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 1...
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In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 10:00. By 8:00 PM I was not feeling well. Had all of the side effects, chills, fever, muscle aches, joint pain and a wicked headache. Monday was the same minus the headache. Today, still have joint pain and feel very weak. The nurse that gave us our vaccinations said that if we experienced any of the side effects, we should let our primary physician know. Hopefully all of this is normal and I will be back to my normal self soon. I am concerned because most of the information I have read says 24 hours and effects should be gone. Not so with me. Hope all is well with you and your family. " Spoke w/ pt on phone and she stated her s/s are subsiding, other than the arthralgia, RN
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| 65 | 2021-02-22 | bell's palsy | Onset of Bell?s palsy 40 minutes after vaccine |
| 65 | 2021-02-23 | migraine, burning sensation |
About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,...
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About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,, and sinuses. States burning feeling is easing yard headache spending to top of head. Client instruct to go home and have husband drive. Plans to take her migrain meds. Says her migraines can start this way too. Left AR 12:13
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| 65 | 2021-02-23 | pain in extremity | Almost immediate nausea, light headed, elevated blood pressure, arm pain |
| 65 | 2021-02-23 | weakness |
I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to ...
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I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to do anything. Couldn't get out of bed and it felt like my skin was crawling all the time. I have never been so sick in my life. I am NOT getting second shot because NO doctor will help me understand what happened to me. But, you need to know!
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| 65 | 2021-02-23 | feeling hot |
My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contac...
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My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9263/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 14:30 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included allergic reaction to almonds and brewers yeast in Sep2019, being pre-diabetic, and osteoporosis. The patient had allergies to codeine (all forms), almonds, brewers yeast, mold and dust. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, alendronate sodium (FOSAMAX), and multivitamin, other supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 15:15, the patient experienced that her cheeks were red and hot. The clinical course was as follows: because of a prior significant allergic reaction (Sep2019 determined to be primarily almonds and to a lesser extent brewers yeast), she waited 30 min. and she didn't notice anything until she left the property and removed her mask. Her cheeks were red and hot. She had a diphenhydramine (BENADRYL) tablet (OTC) which within 30+ min reversed it. The outcome of the events cheeks were red and hot was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-02-23 | feeling cold, tremor |
Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwar...
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Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwards. Couldn?t eat for / days afterwards. Bad dry cough still persists now 2 weeks later. Took Tylenol nothing helps the dry cough
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| 65 | 2021-02-24 | pain in extremity |
Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired...
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Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired. started about an hour later. Did not sleep well. Stayed in bed the next 2 days. Tightness in chest went away the second day. Third day I felt like myself. These were things that I also experienced with Covid.
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| 65 | 2021-02-24 | feeling hot |
Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); pos...
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Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 65 | 2021-02-24 | weakness |
Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, ...
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Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, worsening, nauseas . Went home from work that evening around 9:30 p.m. I Vomited as soon as I got home. Felt better but still lightheaded, dizzy, not as bad. No fever. Couldn't sleep. Tuesday, February 23 felt pretty weak, tired some lingering lightheadedness. Stayed home from work. Next day, Wednesday, my right arm around the injection site was pretty sore. Hard to sleep last night. Took Tylenol for arm. Still somewhat sore today, Thursday.
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| 65 | 2021-02-24 | pain in extremity |
No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right ...
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No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right bodice, up the back of my neck and head on only the right side. I took Tylenol, placed hot packs on the area and drank fluids. I took Advil at 4:00 a.m. Fell asleep and woke up at 8 a.m. I had no temperature but headache was intense. I ate a small breakfast and stayed quiet with hot packs on all areas - 5 p.m. I was feeling much better - went to bed at 7:00 p.m. next morning I was ok.
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| 65 | 2021-02-24 | burning sensation |
Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also s...
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Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also some edema under right eye - small sack of fluid - lasted a few days - took benadryl to relieve itching - dissapated after 4 days but skin was very dry & chapped for about 10 days after
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| 65 | 2021-02-24 | feeling cold |
She did not have any reactions initially, but noticed the morning after the vaccine that her regular...
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She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
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| 65 | 2021-02-24 | hot flush |
Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and ligh...
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Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and lightheaded with diaphoresis. EMS evaluated patient on-site. Patient was hypotensive (89/60). 12-lead EKG showed sinus tachycardia, rate 102 bpm, no ST elevation. EMS transported the patient to Emergency Department for further evaluation. In ED, patient was hypertensive (155/65) with all other vitals WNL. Repeat EKG indicated NSR, low voltage QRS, with no ischemic appearing ST changes. ED physician administered 1L saline bolus and 650mg Acetaminophen. Patient reported feeling better and was discharged with a differential diagnosis of vasovagal episode, electrolyte imbalance, and volume depletion.
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| 65 | 2021-02-25 | pain in extremity |
15 minutes after vaccination: stomach queasy and burning in esophagus 12 hours after vaccination: v...
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15 minutes after vaccination: stomach queasy and burning in esophagus 12 hours after vaccination: vomiting and diarrhoea and sore arm
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| 65 | 2021-02-25 | difficulty speaking |
Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we ...
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Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we discussed her reaction to previous Pneumovax 12 years prior. Several minutes following administration of the Pneumovax, she developed scratchy throat and hoarseness. Benadryl was administered with improvement in symptoms. She did not require epinephrine or ER visit. We discussed that she had a higher risk of reaction to the COVID 19 vaccine and advised her to wait 30 minutes post injection. During her wait time she began to develop scratchy throat and hoarseness that progressed over 10 minutes. She was taken to the treatment area where vital signs were obtained and 50 mg of oral Benadryl was given. Initial VS were SpO2 of 98, P 82, BP 140/100. She was alert and oriented. No edema lips or tongue. Heart RRR Lungs CTAB with no wheezes. She remained under observation for 30 minutes, vital signs remained stable and BP ranges from 138-140/80-90. She had noticable improvement in her throat and voice and she was discharged in good condition to home under the care of her husband. They were advised that Benadryl could be repeated in 4-6 hours if needed. Should she develop any facial swelling, shortness of breath, wheezing or lightheadedness they should proceed to the emergency department. Reviewed the newly updated CDC guidance on reactions. Although her reaction was immediate it was not considered severe. CDC advised against getting the second vaccine. She is advised to discuss further with her allergist, Dr if she would like to discuss the possibility of getting the second dose with premedication or other precaution. She and her husband understood well and all questions answered.
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| 65 | 2021-02-25 | weakness |
anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, w...
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anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.
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| 65 | 2021-02-25 | weakness |
one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizzine...
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one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizziness in the evening that went into the next day.
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| 65 | 2021-02-26 | flushing |
Patient had complleted her 30 mintues of observation due to her history of multiples allergies. She...
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Patient had complleted her 30 mintues of observation due to her history of multiples allergies. She had left the building and went to her car when she developed facial flushing and was concerned about an allergic reaction so she presented back to the facility for evaluation. Her blood pressure was 152/98 with recheck 190/108. Hr 80s with pulse ox 100% on room air. She has a ast medical history significant for asthma and hypertension. Benadryl 25 mg was given and Paramedics were on site and took over care. She was stable at time of transfer to the hospital.
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| 65 | 2021-02-27 | migraine |
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second da...
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103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
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| 65 | 2021-02-28 | numbness | Bilateral numbness, headache, tongue feels weird, really tired, hx liver transplant |
| 65 | 2021-02-28 | pain in extremity |
Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe c...
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Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
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| 65 | 2021-02-28 | pain in extremity, weakness |
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night w...
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Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
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| 65 | 2021-02-28 | tremor |
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a ...
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shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 65 | 2021-03-01 | pain in extremity |
Approximately 19 hours after having the vaccination, I awoke with a sore arm, stiff neck, and pinpoi...
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Approximately 19 hours after having the vaccination, I awoke with a sore arm, stiff neck, and pinpoint headache. These symptoms continued throughout the day. At approximately 1:30 pm, I took 2x500mg acetaminophen and the stiff neck and headache pretty much went away.
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| 65 | 2021-03-01 | bell's palsy |
Bell's Palsy - left facial droop 3 days after administration. Went to primary dr. and got rx for Val...
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Bell's Palsy - left facial droop 3 days after administration. Went to primary dr. and got rx for Valtrex and Prednisone.
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| 65 | 2021-03-01 | tingling |
Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in...
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Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot), lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.
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| 65 | 2021-03-01 | pain in extremity |
Light-headedness a few hours after injection. Following morning: Very sore arm; very tired; sligh...
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Light-headedness a few hours after injection. Following morning: Very sore arm; very tired; slight sore throat; generally out-of sorts. Started to improve in the evening. Symptoms resolved by the next morning except for sore arm. 72 hours after injection, just a slightly sore arm and no other symptoms. Side effects were more than from a flu shot but were tolerable.
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| 65 | 2021-03-01 | night sweats |
Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss la...
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Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss lasting 6 weeks
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| 65 | 2021-03-01 | muscle spasms |
Received 2nd shot around 1:30pm,. Approximately 12 hours after 2nd shot woke up shivering and havin...
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Received 2nd shot around 1:30pm,. Approximately 12 hours after 2nd shot woke up shivering and having muscle cramps in legs and feet. I had to actually get out of bed to try and relieve the cramping. I was cold and muscles were cramping but with extra blankets was able to fall back to sleep. Woke up in the morning feeling very sore with muscle pain/aches. Neck was so sore I could barely keep my head up. My whole body hurt, had a bad headache and fever of 100.4 when I finally took it. For the next 24 hours all I wanted to do was sleep. When I woke up the following morning still had a slight headache that went away as day progressed. Just thought you might want to hear about this. Not sure what you do with this information but hope it is helpful.
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| 65 | 2021-03-01 | cold sweat | Simply tired and exhausted. 2 / 28/ 21 felt feverish / clammy. 3/ 2 / 21 still tired and exhausted |
| 65 | 2021-03-02 | burning sensation, numbness |
About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensati...
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About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensation move up into my right side of face. Swelling on right side was noticeable for two days. Mild numbness also occurred that went away as swelling subsided. However on 3/3/21 I am noticing numbness in upper lip and jaw... also mild.
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| 65 | 2021-03-02 | tingling, numbness | Numbness/tingling of right arm |
| 65 | 2021-03-02 | tingling, numbness |
Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got ...
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Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got her 2nd COVID-19 vaccination by Pfizer. She had no ill affects until approximately 10:30 p.m. yesterday (2/23/21) at which time she developed chills her symptoms worsened and by midnight she could not move her arms or her legs and her arms and legs felt numb. She did not have any difficulty breathing. She did not have any numbness in her chest and she did not have any shortness of breath. She did not have any rash and she did not have any swelling or have any headache. She relates that she is better now (2/24/21) although she does still feel like she has weakness of her arms and legs she is now able to walk. The only remaining parenthesia is a little bit of tingling in her right arm. She is still experiencing significant fatigue".
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| 65 | 2021-03-02 | pain in extremity, feeling hot, hot flush |
She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Hea...
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She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility. Information regarding batch/lot number has been requested.
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| 65 | 2021-03-02 | numbness |
Within 1 hour of injection I had numbing in my right face cheek. I liken the feeling to that of when...
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Within 1 hour of injection I had numbing in my right face cheek. I liken the feeling to that of when your Dentist gives you a shot of Nava Caine and it begins to numb. After and hour or so it moved to my left forehead and eventually to my right forehead and was across the entire forehead. Later that night approximately 3 hours later it moved to the top of my head. I would say it lasted for approx 6 hours.
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| 65 | 2021-03-02 | pain in extremity |
experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain rad...
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experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain radiating from my shoulder down to my fingers; left arm weakness; This is a spontaneous report from a contactable physician (patient). A 65-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85; expiration date: unknown) at vaccination age of 65-year-old intramuscularly in the left arm on 20Jan2021 10:30 at a single dose for covid-19 immunization. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85) at vaccination age of 65-year-old intramuscularly in the left arm on 30Dec2020 at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 21Jan2021 after the second Pfizer dose (24 hours after the injection), she began to experience left arm pain radiating from her shoulder down to her fingers. The pain was sharp, constant and associated with left arm weakness. This has persisted for 10 days with no relief and she was still experiencing this pain now. The events were considered as non-serious and did not require treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
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| 65 | 2021-03-02 | seizure |
on 2/4/21, patient developed refractory seizures, requiring hospitalization and antiepileptic medica...
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on 2/4/21, patient developed refractory seizures, requiring hospitalization and antiepileptic medications among others. She had no history of seizures, as well as negative LP studies and negative CNS imaging.
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| 65 | 2021-03-02 | pain in extremity |
soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This 65-year...
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soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) intramuscularly on 08Jan2021 (at the age of 65-years-old) as a single dose in the left arm (deltoid) for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bioidentical hormones, levothyroxine sodium (LEVOTHYROXIN), and liothyronine from unspecified date for unspecified indications. The patient reported an allergy to latex gloves with a reaction of rash. On 08Jan2021, the patient experienced soreness in her arm. The outcome of soreness in her arm was unknown. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-03-03 | migraine | Fever migraine extreme fatigue Migraine headache since this vaccine |
| 65 | 2021-03-03 | feeling hot |
Later in the evening my throat felt swollen on both sides. I had a warm sensation going through my b...
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Later in the evening my throat felt swollen on both sides. I had a warm sensation going through my body. Next evening throat felt swollen on both sides but not as bad as the first evening. Warm sensation could be from vaccine or anxiety. Not for sure.
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| 65 | 2021-03-03 | flushing |
Pt had a hypersensitivity reaction to her COVID 19 vaccine. Her symptoms included becoming flush and...
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Pt had a hypersensitivity reaction to her COVID 19 vaccine. Her symptoms included becoming flush and tachycardic. Her BP was elevated initially (209/117). She did endorse forgetting to take her BP medications this AM and failing to eat anything for breakfast. A medical response was called and the patient received 10 mg of Zyrtec po. An EKG was obtained and read as normal by the responding provider. The patient was observed for a period of 90 minutes until her symptoms resolved and her BP and HR improved. She also had a snack and drink.
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| 65 | 2021-03-03 | flushing | itchy all over, flushing. Evaluated by EMS-Cleared |
| 65 | 2021-03-04 | pain in extremity |
0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-1...
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0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-18.She states no issues with 1st dose on 2/12.0923 Pt report pain and HA has resolved now she feels sleepy. VS as follows 148/86, HR-68, 02 sat 98%, r-20. Pt grandaughter accompanied her here.0937 Pt allowed to go home with grandaughter she reports she feels much better. VS as follows 150/89, HR-77, 02 sat 96%, r-18. Pt instructed to f/u with MD as needed.
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| 65 | 2021-03-04 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old fema...
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Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiration date: May2021), via an unspecified route of administration in the left arm on 31Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination was done at a hospital. The patient's medical history included Reynold's syndrome (21 years old at diagnosis), Sjogren's (diagnosed at 30 years old), mixed connective tissue disease (diagnosed around 30 years old), and fibromyalgia (late 40s at diagnosis). There were no concomitant medications. The patient previously received a tetanus shot for immunization on an unspecified date and was allergic to the tetanus shot. This happened when she was 21 years old. The patient also got the new pneumonia shot on 12Jan2021 in her left arm for immunization at the age of 65 years old. The patient got her first dose of BNT162B2 on 31Jan2021. The patient stated she was supposed to get second vaccine 21Feb2021 but that she went to emergency room 13Feb2021 with extreme right eye pain and numbness in lip. She was diagnosed with Bell's palsy. The patient stated that she was not admitted to the hospital, and she just seen in the emergency room. It was reported that it initially worsened, that her eyes were definitely worse until a week later she was scheduled to see her physician and on Wednesday 17Feb2021 she started taking eye drops and now they have not gotten any worse. The doctor said it was not known if it was caused by the vaccine, and stated the patient has certain autoimmune problems Reynaud's, Sjorgen's and mixed connective tissue disorder, all diagnosed prior to vaccine. The patient had no family history relevant to the event. There were no relevant tests. The outcome of the event was not recovered.
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| 65 | 2021-03-04 | flushing, tingling, numbness |
Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat cons...
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Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat constricted but didn't have a problem with breathing. 8 days later still have "pens-and-needles" in face chest and arms some numbness in my face.
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| 65 | 2021-03-04 | numbness |
Following day around 8pm started having neck pain then numbness in left arm and face with slight hea...
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Following day around 8pm started having neck pain then numbness in left arm and face with slight headache. Lasted two days. Let up a little on third and 4th day. Day 5 almost gone still lingering numbness in left side of face.
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| 65 | 2021-03-04 | numbness | Numbless head face arm and headache. Call to Dr |
| 65 | 2021-03-04 | hot flush |
Patient was administered pfizer covid vaccine at off-site clinic. approx 10 min post injection, she...
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Patient was administered pfizer covid vaccine at off-site clinic. approx 10 min post injection, she developed hot flashes, mild sob, and consistent tearing. she did not require any meds on site. Her BP was 222/125. EMS was called. they confirmed BP reading and advised transport. Patient declined transport.
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| 65 | 2021-03-04 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer (patient)¬. A 65-year-old female...
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Sore arm; This is a spontaneous report from a contactable consumer (patient)¬. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 11Jan2021 at 12:00 (at the age of 65-years-old) at a single dose for COVID-19 immunisation. Medical history included osteoporosis, stroke history (35-years-old), significant lactose intolerance, gastrointestinal (GI) issues, and allergy to Caine family of drugs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included evolocumab (REPATHA SURECLICK) and lorazepam (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm in 2021. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 65 | 2021-03-04 | feeling cold |
nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gav...
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nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.
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| 65 | 2021-03-04 | tingling |
started feeling quite itchy at and around the area of the injection site in the upper left arm/It is...
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started feeling quite itchy at and around the area of the injection site in the upper left arm/It is a distinct tingly itchy sensation; . It has been pretty much continuous since yesterday and continues today. It is a distinct tingly itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 65-year old female non-pregnant patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: unknown) via unspecified route of administration, on left arm at 11:45, on 23Jan2021, at single dose for COVID-19 immunisation. The patient medical history included heart attack, high blood pressure, high cholesterol. The concomitant medication included carvedilol, rosuvastatin, glycine, glucosamine, colecalciferol (D3) and msm. The patient previously took tylenol and experienced allergies. It was reported that about a week after the injection on 30Jan2021, I started feeling quite itchy at and around the area of the injection site in the upper left arm (as reported). It has been pretty much continuous since yesterday and continues today (as reported). It is a distinct tingly itchy sensation. It was reported that patient didn't see anything unusual in this around the area of the injection site. The patient used cortisone which helped slightly. The patient was not sure if it was safe to take second dose. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was not overweight at all. The outcome of the events was recovering Information on the lot/batch number has been requested
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| 65 | 2021-03-05 | weakness, tremor, flushing, pain in extremity |
1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, we...
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1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, weakness in arm and then all over, shaking, dry mouth and tongue. The worst of it lasted about 5 minutes but weakness and shaking continued for about an hour. 2) Over the course of several hours developed sore arm and headache which worsened over the next 12 hours but was not terribly bad. 3) Days 3-6 had stiffness which began at injection site and went up left shoulder into the left side of neck. Resolved by day 7. 4) ON DAY EIGHT I developed a rash and itching at the injection site. Also had a dry cough and sinus drainage but cannot be certain this was from the vaccination but the rash and itching definitely was. The rash resolved by day 12. It was not terribly bad and no drugs were needed to calm the itch.
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| 65 | 2021-03-05 | cold extremities, feeling cold, pain in extremity |
Approximately 20 hours after injection, I began to have chills and fatigue; by 6pm, chills/coldness ...
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Approximately 20 hours after injection, I began to have chills and fatigue; by 6pm, chills/coldness seem to be strong in my feet slowly moving up my entire body; after about one hour; the chills subsided and a fever ensued ranging from 99.7 - 102.9; low grade fever remained thru the night with aching in the left leg; had some fatigue the next morning but by 1pm, was feeling much better with very little fever and a little soreness in the right arm; again around midnight, feet were extremely cold and aching (had to put on some socks in order to get to sleep). I would say the side effects lasted about 36 hours.
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| 65 | 2021-03-05 | feeling hot |
Patient reported felling hot and dizzy. Pt was alert and oriented. Patient was relocated to clini...
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Patient reported felling hot and dizzy. Pt was alert and oriented. Patient was relocated to clinic room bed and placed in supine position.. Extremeties were elevated. Pt began to report feeling better almost immediately. Blood pressure was obtained at 1:03pm. BP was 146/96, HR 55. Pt was instructed to remain in reclined position. She was alert and conversational throughout. At 1:10p, another BP was obtained of 138/68. HR 58bpm. Pt continued to report feeling better. She was able to sit up and remained seated for several minutes to ensure no orthostatic hypotension. She was able to stand and left clinic at 1:16pm. Impression of vasovagal reaction post injection.
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| 65 | 2021-03-06 | tingling |
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: The patient had ting...
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Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: The patient had tingling above and below her lips. Benadryl was given after a few minutes of monitoring. After administration of Benadryl, patient started experiencing a tingling sensation in her hands. 1 dose of the 0.3 mg epinephrine injection was administered before 911 was called. Patient's vitals were taken by paramedics. She has fully recovered and is at home resting comfortably.
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| 65 | 2021-03-07 | tingling, pain in extremity |
3:20PM C/O TINGLING TO RT 5TH DIGIT. A/O, PINK, W/D, RESP REG WITH EASE. DENIES ANY SOB OR DYSPNEA. ...
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3:20PM C/O TINGLING TO RT 5TH DIGIT. A/O, PINK, W/D, RESP REG WITH EASE. DENIES ANY SOB OR DYSPNEA. STATES SHE 'HAS BEEN NERVOUS ABOUT GETTING THE SHOT.' 4:12PM STATES 'SHE IS FEELING BETTER'. 3-3-2108:10AM TC PT STATES 'STILL HAS TINGLING TO RT 5TH DIGIT, HEADACHE & RT ARM IS NOW SORE. STATES SHE 'FEELS LIKE SHE IS PREOCCUPIED AS SHE WAS SO NERVOUS ABOUT GETTING THE SHOT'. ADVISED TO F/U WITH HER PCP IF S/S CONTINUE. SHE STATES 'SHE MAY TAKE A TYLENOL TONIGHT AT BEDTIME.'
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| 65 | 2021-03-07 | facial pain |
Woke at 3am with chills, body aches, headache and fever. Fever was 2 degrees higher than normal tem...
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Woke at 3am with chills, body aches, headache and fever. Fever was 2 degrees higher than normal temp and continued until about 8pm when I took ibuprofen. Symptoms were gone when I woke up on 3/6. On 3/8 I experienced swollen glands and a cold sore. the right side of my face was achy. Ibuprofen helped.
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| 65 | 2021-03-07 | tingling, numbness |
immediately following vaccination patient reported paresthesias and numbness on right neck and arm. ...
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immediately following vaccination patient reported paresthesias and numbness on right neck and arm. Vital signs within normal ranges except blood pressure 142/94 mmHg. Patient remained awake, alerted, and oriented: no respiratory, gastrointestinal, or dematologic symptoms reported. Patient transported to emergency department where physical and neurological exam notable only for decreased sensation on right arm. Cranial nerves intact and normal strength in all extemities. Patient observed, able to ambulate without assistance, and discharged to home stable.
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| 65 | 2021-03-07 | pain in extremity |
swollen eyelids within 35-45 minutes of shot, normal next morning. no swelling at shot site, slight...
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swollen eyelids within 35-45 minutes of shot, normal next morning. no swelling at shot site, slight arm soreness overnight.
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| 65 | 2021-03-08 | weakness |
Approximately 15 hrs after injection and feeling no side effects all day. I woke up with sweats - us...
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Approximately 15 hrs after injection and feeling no side effects all day. I woke up with sweats - used an ice pack to cool. 100.7 temp (normal temp is 97.7) then chills which required a heated blanket to get some comfort. I was dizzy and could not stand without support for any length of time during the next 5 hrs. My sensecof taste was affected for almost a week- a weird "milk of magnesia " taste no matter what I ate. 12 hours later I was well enough to be on my feet, 24 hours after that I had very little recollection of the prior days activities or conversations. (Like a lost a day in my mind- that was scary- what's in this vaccine??) The next several days, did not have my normal energy level. I am a healthy person, high energy person. I have never taken a flu vaccine, my body has a pretty great immune system, but I did this vaccine " mostly, for the good of the whole"- I will think long and hard before I would take this vaccine again or recommend doing so to anyone else. I have been told- those with the greatest immunity system will have the worst side effects- I am not sure that makes
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| 65 | 2021-03-08 | pain in extremity |
Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and...
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Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and felt very bad. Was taking Tylenol every 4-6 hours but headache continued to get worse throughout the evening and into the night 3/4-3/5/21. Left arm began hurting too on 3/4/21 but no swelling or redness, just sore. Finally began feeling a little better by late evening on 3/5/21 and headache was beginning to ease but did not fully go away until 3/6/21. Was able to manage the side effects at home without going to my Dr.
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| 65 | 2021-03-08 | migraine | Migraine headache, chills, fever, body ache, stomach ache |
| 65 | 2021-03-08 | pain in extremity, weakness |
Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. ...
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Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. Started to black out and went down but not unconscious. Then bowel movement and nausea at same time and started dripping sweat profusely. Soaked my clothes. So weak could not get up or felt as though will pass out. Then got the chills and loud ringing in my ears. Whole episode lasted about 20-30 minutes then went to bed at 7:30 p.m. felt so exhausted and fatigued. Woke up about 4a.m. arm hurt but felt okay. Little off balance, fatigued, weak all day. Next day arm sore but improving. Now fine. Saw doctor today, he advised me to report and wait to see advice from Pfizer as to get2d dose or not.
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| 65 | 2021-03-09 | discomfort, feeling of body temperature change, flushing, tingling, weakness |
First my bp my who life has been 130/80 I first noticed I was feeling very flushed, didn?t make much...
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First my bp my who life has been 130/80 I first noticed I was feeling very flushed, didn?t make much of it. I don?t take my bp,often, dr offices etc. 4 weeks ago, I felt pressure around eyes, in back of neck, weak, dizzy. My bp had spiked to 203/104, my husband called the ambulance. I went to ER. Bp went down, I came home, same thing happened the next day. Back in again.... Since then, I have had just about every test possible. I am perfectly healthy on paper. I just don?t know what to,do.... have now taken some bp meds and beta blocker. I can feel my bp spiking several times a day. 170/93 and then after a while back down again. I feel like I might be allergic to whatever is in my body. My hands and face tingle, I feel hot and then cold. I am praying this will ease it way out after the vaccine wears off. Needless to,say I am super concerned. I have ALWAYs been very healthy, fit and happy with a busy life.
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| 65 | 2021-03-09 | pain in extremity |
I didn't realize until yesterday that my symptoms could be related to my vaccine but, Sunday morning...
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I didn't realize until yesterday that my symptoms could be related to my vaccine but, Sunday morning 3/6 I woke up and both my hands felt achy, it got worse over the morning ( 6 out of 10 on the pain scale) so I took Tylenol 650 mg, and rubbed CBD cream on them. It helped but the ache ( which feels like severe arthritis) came back in the evening. This has been continuous since Saturday morning. Both hands and mostly aches in the thumbs and wrists migrating up into my forearms. I continue to take the Tylenol BID. The Tylenol controls it for a while. Today the ache is lessened some ( maybe 4-5 out of 10 on the pain scale). I have not contacted my Physician. I've had no fever or other problems, just this achy, arthritis feeling in my hands and forearms.
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| 65 | 2021-03-09 | numbness, tingling, pain in extremity |
The day after the vaccination my legs felt weak, that feeling went away in a day I believe. At nigh...
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The day after the vaccination my legs felt weak, that feeling went away in a day I believe. At night my feet are usually cold but I noticed An increased numbness in my toes and tingling. The tingling was daily not just at night . I saw Dr. the end of February for another issue and just mentioned in the past 2 weeks increased tingling in my feet and up to lower half of my legs. I was also having shooting pains in my feet which seems to be getting worse as of today. I?ll call Dr. to report this tomorrow. The pain keeps me awake at night and even wakes me up.
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| 65 | 2021-03-09 | pain in extremity, feeling jittery |
jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a...
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jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 01Feb2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient medical history was not reported. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication/other medications given within two weeks included 'Metropol.' There was no other vaccine given to the patient within four weeks. On 01Feb2021 12:00, the patient experienced sore arm, first day brain fog and loss of some exercise ability. The patient also experienced jitteriness two days after (03Feb2021). No treatment given for the adverse events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Feb2021. Information about lot/batch number has been requested.
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| 65 | 2021-03-10 | tremor |
Patient had history of anxiety with previous vaccines, started to become anxious when she though she...
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Patient had history of anxiety with previous vaccines, started to become anxious when she though she lost her vaccine card. Patient experience the shakes, increased blood pressure 179/131 with pulse 111 pm, shortened breathing. We called 911, took her blood pressure, took her mask off to view face, offered water and ice pack before EMS arrived. Epinephrine not administered.
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| 65 | 2021-03-10 | muscle spasms |
Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fat...
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Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-03-10 | pain in extremity | Sore arm Headache Palpitations All lasted 24 hours and then completely resolved |
| 65 | 2021-03-10 | pain in extremity | Sore arm, fatigue, chills & low fever, body aches. Lasted about 48 hours. |
| 65 | 2021-03-10 | feeling cold |
Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold insi...
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Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold inside, shaking inside
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| 65 | 2021-03-10 | flushing |
apprx 2 minutes after shot, upper and lower lips, tongue started to tingle and get numb. some swelli...
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apprx 2 minutes after shot, upper and lower lips, tongue started to tingle and get numb. some swelling of lips tongue, roof of mouth and throat started to itch, flush feeling. Observed for apprx 10 minutes, symptoms did not go away, offered care in emergency room. Admitted 11:28 am about 18 minutes after shot. Observed until 12:05pm, took two Benadryl, 3 corticosteroids, and pepsid. Became drowsy, slept about 1 hour. Symptoms went away was released a round 3:00pm. Advised not to get second dose
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| 65 | 2021-03-10 | muscle spasms | chills, fever, vomiting, muscle spasms, extreme fatigue, for three days; fatigue lasting 7 days |
| 65 | 2021-03-11 | numbness, feeling hot |
About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my...
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About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my arm and my hand went numb . I waited a few more minutes then I was released. Then 1/2 hour later my eyes were very sensitive to light I wore sunglasses. Then five hours after the shot I had chest discomfort on left side of my chest which felt like I was having a heart attack pain subsided then every 2 hours it came and went until the middle of the night. Then next day still having same chest pain. Then I had difficulty swallowing was choking so I called my doctor. I also had trouble breathing. Dr. Advised to go to ER if I needed to. I rested and rested and monitored myself. Blood pressure fluctuated somewhat. Still had chest pain and discomfort 24 hours after the vaccine. I had never had chest pain or discomfort before. It was quite alarming. Not being able to swallow was alarming also. Several years ago I had an allergic reaction to a cleaning problem some of the same symptoms it was very scary no heart or chest pain with that allergic reaction to a cleaning product that had bleach in the product.
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| 65 | 2021-03-11 | weakness, migraine |
Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensit...
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Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensitivity. I have migraine disease but since I began Aimovig injections nearly a year ago I have very few migraines, Those I have had have been extremely mild, just headache usually relieved by otc meds. Additionally I have not had nausea and vomiting with any migraine episode for many years. When I woke at yesterday morning, I was in extreme pain across the right side and back of my head and down to my neck and shoulders. 9 out 10. I took my prescription, Eletriptan .5 mg at 5:45 and went back to bed. It gave little relief of symptoms. I was unable to sleep and at about 7 a.m. I was hit with waves of nausea and extreme violent vomiting. This last for several minutes. At approximately 9 a.m. I took a 2nd dose of Eletriptan and slept a little. Again at about 11: a.m. I was hit with another round of extreme nausea and vomiting which lasted about 5-6 minutes. I slept a bit and around 3 p.m. was finally able to drink a little water. Still very weak but pain had subsided significantly, down to about a 4 / 10. By 6 pm. I was almost pain free ? symptom free though very weak still. Ate a little at about 7 p.m. I know this was a migraine which I am diagnosed with but it was extreme even for me, and especially in recent years. It was very unusual in timing and severity and I felt it needed reporting.
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| 65 | 2021-03-11 | tenderness |
Thought possibly from covid vaccine. Inflammation in right eye ,red, very light sensitive, eye fe...
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Thought possibly from covid vaccine. Inflammation in right eye ,red, very light sensitive, eye felt bruised to touch. Noticed redness and light sensitivity about 5 pm on Feb 18. During that night eye hurt badly from sensitively. Went to Dr next morning prescribed eye drop for swelling was not an infection,improved greatly at Dr appointment a week later. Never had this happen before .
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| 65 | 2021-03-11 | pain in extremity | Tiredness for several hours followed by chills, fever, arm pain, headache for 30 hours. |
| 65 | 2021-03-11 | pain in extremity | mild headache, sore arm, fatigue |
| 65 | 2021-03-12 | weakness | At 1330 patient started with tongue swelling and general weakness |
| 65 | 2021-03-12 | pain in extremity | I experienced sore arm, chills, muscle aches, and headache. I remained in bed for the whole day. |
| 65 | 2021-03-12 | flushing, pain in extremity |
March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when lay...
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March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when laying down. Self treated with over the counter Dimenhydrinate 3 times. For nausea. Tylenol 1. Headache did not go away after 4 hours. Took a Butalb/asa/caff/codeine 30mg at 4am. (PRN order for migraines) Headache eased up a lot. Felt flushed through the night. March 12, 2021- About mid afternoon on started a painful swelling under left armpit. (Injection was in left arm). Treated with Ice packs. March 13, 2021- swelling under left armpit worsening. Cannot put my arm down. Treating with ice packs. Nausea, headache are better. Body aches are reduced.
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| 65 | 2021-03-12 | pain in extremity, feeling cold, muscle spasms |
Within 30 minutes upper body muscles became very achy. Within next hour sinus tickle and nose runnin...
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Within 30 minutes upper body muscles became very achy. Within next hour sinus tickle and nose running. Within two hours a tickling discomfort in lungs, coughing. (Left lung in particular.) Remembered then in early 2000's had pneumonia several times with scarring on left. Monday evening while trying to sleep much sneezing, nose blowing, fluids moving into chest and by morning a severe left calf cramp for which I had to stand up to relieve. Leg very sore until the 12th. Been very cold all week.
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| 65 | 2021-03-13 | migraine |
3/13/2021 migraine headache the following day, never had a migraine before, woke up at 5:00 A.M. the...
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3/13/2021 migraine headache the following day, never had a migraine before, woke up at 5:00 A.M. the following morning with eyes feeling very heavy, headache and lightheaded, sunlight bothered me. Took Advil and stayed in a darkened room. Felt fine 3/14/21 when I woke up.
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| 65 | 2021-03-13 | bell's palsy |
Bells Palsy Medicine prescribed: Valacyclovir 1GM tablets, Prednisone 20MG tablets, Doxycycline HY...
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Bells Palsy Medicine prescribed: Valacyclovir 1GM tablets, Prednisone 20MG tablets, Doxycycline HYC 100MG tablets The meds have had no effect so far.
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| 65 | 2021-03-13 | pain in extremity |
Pain in shoulder and arm. Limited motion with shoulder. Pain radiates down the arm. Pain when using...
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Pain in shoulder and arm. Limited motion with shoulder. Pain radiates down the arm. Pain when using the arm.
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| 65 | 2021-03-13 | pain in extremity |
Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I too...
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Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I took Benadryl. 2nd Day, Next morning: headaches. Tylenol. Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful. Very tired. Rash is gone. Mid day: anxiety and feeling down. Called Dr. and got nurse and then called therapist. headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back. Benedryl Headache. Tylenol 3rd day: Diarrhea. headache, still foggy and tired.
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| 65 | 2021-03-13 | pain in extremity |
Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Fl...
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Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Flu-like symptoms from that time for another 12 hours or so: body aches, tiredness, nausea.
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| 65 | 2021-03-13 | night sweats, weakness |
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got naus...
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The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea. Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak. Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They gave me a shot of steroids and Benedryl. Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
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| 65 | 2021-03-13 | weakness |
Very tender and swollen lymph nodes on left side -- continued low energy - sore throat and cough whe...
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Very tender and swollen lymph nodes on left side -- continued low energy - sore throat and cough when lying down. (I know the lymph nodes are from the injection -- not sure about the rest of it.) Not overly concerned -- just reporting so you have accurate data.
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| 65 | 2021-03-14 | tremor, weakness |
Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to ...
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Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
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| 65 | 2021-03-14 | feeling of body temperature change |
fatigue, sore throat, HA, feeling hot and cold, light headedness/dizziness recommended she get covid...
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fatigue, sore throat, HA, feeling hot and cold, light headedness/dizziness recommended she get covid tested due to sore throat being reported. stated she would check her local pharmacy
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| 65 | 2021-03-15 | tremor |
Headache, Aleve , the Aleve helped some, resolved after 48 hours Body aches, Bolus (Dialadid) from p...
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Headache, Aleve , the Aleve helped some, resolved after 48 hours Body aches, Bolus (Dialadid) from pain pump 1 time, Aleve, duration 72 hrs, Dizziness, 72 hours, had to be very careful when I walked around or stood up Triggered a Fibromyalgia flair up. My pain level has gone up to 6 in some areas, started 48 hours after vaccination and is continuing though long-term pain is coming down. Increased the shakiness I have in my hands, 72 hours, it has gotten somewhat better
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| 65 | 2021-03-15 | pain in extremity |
Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then t...
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Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then traveling up inside of arm to arm pit. pain subsided but arm is still swollen as of today 03/16/2021.
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| 65 | 2021-03-15 | pain in extremity |
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Se...
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Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
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| 65 | 2021-03-15 | pain in extremity |
Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subs...
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Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving. Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic. Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
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| 65 | 2021-03-15 | pain in extremity |
The evening of the vaccine she could not move her left arm at all. She is still having limited movem...
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The evening of the vaccine she could not move her left arm at all. She is still having limited movement and pain. She can not lift her arm above her head to remove her shirt without significant pain.
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| 65 | 2021-03-15 | night sweats, numbness |
Time of injection felt a stinging sensation, lasted a few minutes. Within hour, iced arm as was qui...
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Time of injection felt a stinging sensation, lasted a few minutes. Within hour, iced arm as was quite sore. Woken during night with chills, sweats and feeling of numbness from shoulder down to elbow and unable to raise arm. Took 2 acetominophen and iced arm, able to fall back to sleep. Very sore and difficulty in raising arm for 2 days.
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| 65 | 2021-03-16 | weakness |
1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late nigh...
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1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late night, subsided next morning. 4th day- same as 3rd 5th day- extreme dizziness at night, continued next day with sick feeling, stomach pain, leg weakness. Heart palpitations and racing(during night) Symptoms continued following 6th-10th days. Went to hospital emergency room 11th day due to doctor concerns of possible aFib. Admitted in Observation Unit overnight with IV fluids & heart monitor. Heart attack ruled out. Tachycardia event with follow up at cardiologist.
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| 65 | 2021-03-16 | tingling |
5-7 days after her vaccine, pt woke up with tingling to the L arm and L side of face/cheek; Has si...
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5-7 days after her vaccine, pt woke up with tingling to the L arm and L side of face/cheek; Has since had a few episodes of tingling to the L cheek w/o weakness, speech change, vision change. Pt's vaccine card does not have the lot # written on it.
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| 65 | 2021-03-16 | tingling |
About an hour after receiving the vaccine patient experienced "tightness" in throat, no swelling pre...
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About an hour after receiving the vaccine patient experienced "tightness" in throat, no swelling present. Two hours after receiving vaccine patient experienced a "prickly sensation" and broke out in red bumps on back, arms, wrists, stomach, legs, and behind knees. Bumps were red in color at itchy. Patient took a dose of diphenhydramine and that helped throat tightness, but did not relieve rash. Patient bathed in Dawn Dish soap, which helped to calm the itch temporarily. Rash has not completely gone away, as of 3/17/21 patient still suffers from itchy bumps on legs.
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| 65 | 2021-03-16 | bell's palsy | Belle's Palsy: prednisone, analgesics, anti-viral medications |
| 65 | 2021-03-16 | bell's palsy, facial paralysis |
I was diagnosed with bells palsy in 2005. Full recovery with small amount of paralysis remaining on...
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I was diagnosed with bells palsy in 2005. Full recovery with small amount of paralysis remaining on left side of face (left corner upper lip). About 5 days after vaccine noted chewing differently. Eight day after vaccine new paralysis on left side of face now extending to entire jaw area and upper and lower lip. New paralysis on right side of face. Eye won't blink, eye brows won't raise, unable to puff jaw and area next to noise won't move. Twelve days after vaccine minimal improvementlater
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| 65 | 2021-03-16 | pain in extremity |
Lightheaded first. Arm soreness, Late evening tired, headache, chills, fever up to 100.6, slight bl...
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Lightheaded first. Arm soreness, Late evening tired, headache, chills, fever up to 100.6, slight blood pressure increase, pulse to 99 (normally 65), chest pain. Woke up 2/17 feeling better. Fever down to 98.8, pulse down to 74
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| 65 | 2021-03-16 | tremor |
Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 ...
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Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 P-82. Doctor available in Observation area to evaluate pt and pt taken to Clinic via W/C by R.N..
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| 65 | 2021-03-16 | weakness |
Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomitin...
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Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomiting 3 or 4 times during each episode. I took a single dose of Zofran at about 2 pm and had last vomiting episode around 4 pm. Vomiting episodes lasted a total of about 6 hours. I had chills for about an hour right after 1st vomiting episode. I had significant left arm pain that prevented use of arm for 2 days. I also had extreme weakness the 1st day, I couldn?t get out of bed except to vomit. I got the vaccine on Wednesday and didn?t feel fully recovered until Sunday.
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| 65 | 2021-03-16 | weakness, migraine |
Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1...
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Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1 ear, but no fever or redness or pain in ears. No other infections or symptoms thereof. ER visit with blood and urine tests and an MRI revealed nothing definitive. Response to symptom-alleviating shots was less than desirable, hence the MRI. Sent home with anti-vertigo and anti-nausea prescriptions and referral to an ENT specialist (appt set for Mar 21). Patient unable to do anything but lie down. Efficacy of prescriptions is pending. Symptoms are projected to gradually subside and eventually disappear.
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| 65 | 2021-03-17 | difficulty speaking |
30 mins post vaccination, client complained of new onset tickling in throat, voice hoarseness then c...
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30 mins post vaccination, client complained of new onset tickling in throat, voice hoarseness then cough. Client awake and alert. Vital signs stable, BP slightly elevated 164/71 @ 1226, O2 sats 98%. Blood glucose 154. Per staff protocol, Benadryl discussed but doctor declined to order administration. Daughter is driving her home.
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| 65 | 2021-03-17 | inability to speak |
Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vas...
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Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vascular Accident, a CVA, a Stroke @ 5:05a.m. in our home. My entire right side was paralyzed & unable to speak. My husband alerted #911 & fortunately @ the hosp. I received immediate life saving care. I had a C.T. Scan which revealed #2 blood clots in the left side of my brain. Intravenous T.P.A. was administered & then a thrombectomy was performed. Hospitalized approx. 5:45a.m on Sun., Feb. 28th, 2021 till my discharge on Wed., March 3rd, 2021@ 5:30pm.
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| 65 | 2021-03-17 | tingling, feeling hot, flushing, numbness |
Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed ...
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Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed flushing of the face followed by erythema of the body, warmth and tingling. This was accompanied by numbness, a change in her vision and mental alertness. Patient reports similar symptoms occurred in the past when she experienced anaphylactic reactions, such as with bee stings.
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| 65 | 2021-03-17 | pain in extremity |
general malaise and sore arm on March 16th. Wednesday felt better but not perfect. March 18th got ...
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general malaise and sore arm on March 16th. Wednesday felt better but not perfect. March 18th got up with headache, nausea and dizziness.
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| 65 | 2021-03-18 | tingling, pain in extremity |
Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs...
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Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs, pis and needles sensation toes, slight headache, sore arm
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| 65 | 2021-03-18 | tremor, pain in extremity |
Mild soreness below injection site the day of injection. Fever started day after injection lasting 5...
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Mild soreness below injection site the day of injection. Fever started day after injection lasting 5 days, above 100 everyday, 101 to 102.2 on the 4th and 5th days, then back to normal (97.8). Chills and shaking on 3rd and 4th days. Mild nausea and dizziness. Stayed in bed 2nd to 4th day with fatigue. Coughing mostly when temperature was high. Still some coughing now after 10 days. Severe allergic reaction with rash starting at groin area the day after injection, moving up sides to underarms the 3rd day, then hands and feet the 4th day. Dermatologist recommended not getting 2nd shot.
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| 65 | 2021-03-18 | weakness |
Patient reports receiving the second dose of the vaccine on 3/17, feeling weak that night. on 3/18 ...
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Patient reports receiving the second dose of the vaccine on 3/17, feeling weak that night. on 3/18 she passed out x2 for several seconds each time. No postictal response. Patient was brought to the ER, diagnosed with vasovagal response Chest xray, EKG, labs normal
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| 65 | 2021-03-18 | seizure, pain in extremity |
Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing...
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Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-03-18 | bell's palsy |
The patient called the pharmacy reporting that she developed Bells Palsy shortly after receiving her...
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The patient called the pharmacy reporting that she developed Bells Palsy shortly after receiving her first COVID-19 Pfizer BioNTech vaccine. She did report that she had some dental procedure within the same time frame and was not sure if the vaccine or her dental work that caused her symptoms. She did tell me that her symptoms were on the same side as her dental work and that her symptoms resolved within 2 days, but her physician did tell her it was Bells Palsy. She called our pharmacy as she is supposed to receive her second COVID vaccine tomorrow and was not sure if she should still get it still with this reaction. I informed her that the vaccine was unlikely to be the cause of her Bells Palsy symptoms and that she is still indicated as an individual who should receive the second vaccine.
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| 65 | 2021-03-18 | flushing | intermittent Facial flushing beginning 3 days after dose# 1 was administered |
| 65 | 2021-03-18 | feeling hot |
uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache;...
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uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL9266), via an unspecified route of administration in the right arm on 19Feb2021 at 12:00 PM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL), pravastatin (PRAVASTATIN), eicosapentaenoic acid ethyl ester (VASCEPA) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (lot number: EL9264), via an unspecified route of administration in the left arm on 29Jan2021 at 01:15 PM (at the age of 65-years-old) for COVID-19 immunisation, prochlorperazine maleate (COMPAZINE) and experienced Compazine allergy and codeine and experienced codeine allergy. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet on 19Feb2021 at 11:00 PM. The patient did not receive treatment for the events. The outcome of events, low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet was recovering.
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| 65 | 2021-03-19 | tremor, weakness |
I woke up about 11 hours later, in the middle of the night. I felt radiating heat going through my ...
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I woke up about 11 hours later, in the middle of the night. I felt radiating heat going through my body. I could not get warm. I started shaking violently from being cold. This probably lasted about 20 minutes. I think I had a fever, but I didn't want to move once I got warm. I cat napped for the rest of the night. I had a headache the next day. I took some Tylenol the next day alternating with ibuprofen. I was unable to get out of bed for two days. I stopped taking the medicines this morning. I feel week today, but other than that, I feel fine.
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| 65 | 2021-03-19 | pain in extremity |
Vaccine injection (right arm) 1015 am 3/17/21. Felt sore arm (right) , dull headache and slight chi...
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Vaccine injection (right arm) 1015 am 3/17/21. Felt sore arm (right) , dull headache and slight chills and enlarged lymph on right side neck below ear ~7pm. Following day 10/18 had dull headache and sore arm but minor significance. Friday 10/19, slight sore arm, no headache. Around 7pm felt sore right nipple. Upon examination it appears to be a small 2mm cyst-like bump -- white, round, mildly painful, a bit itchy. Inside of right breast felt itchy and became rash like red when rubbed/scratched to relieve irritation. Saturday 10/20 Noon, right nipple still sore and a bit itchy, bump still there, rash from rubbing night before has subsided some but still there. No recurrence of headache, pain in arm at injection site or sore lymph node on right neck. Have not consulted with a medical professional but will do so if condition persists on Monday.
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| 65 | 2021-03-20 | tingling, pain in extremity, involuntary muscle movements, tremor |
After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved w...
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After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved with exception of lingering headache for about 2 weeks. Evening after Dose 2, sore arm, worse headache, next day burning eyes, felt like flu. After 48 hours all improved but headache lingered in top of head pressure and nausea. On 3/3/21 8:15 am full blown sharp pain left side of head and then vise grip type headache like top of head was going to explode, severe shaking uncontrollable jerking, stuttering, worst headache ever, high BP over 200/170. Went to ER. CTA head wi 3D reconstruction, labs, etc. gave Toradol, Ativan Zofran Compazine and Fluids, Released after several hours, unspecified headache. Slept for 11 hours, next day severe brain fog and fatigue. On 3/6/21 awoke with same dull headache, but seemingly more jitteriness, by 10:40, another full blown extremely painful headache pins/needles from head to toe. Ambulance arrived BP 208/160ish. Transport to hospital. Ran many tests CT, etc. Gave Morphine, sent home after 5 hours. Saw Neurologist 3/17
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| 65 | 2021-03-20 | tingling |
Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, uppe...
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Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, upper chest,back and thighs. Seen by PCP and communicated with my rheumatologist . By next day upper lip felt tingly and full Dri increased my daily medrol to 8 mg .as throat felt tight . Noted next day mucoid eruptions on upper lips ,palate. Enlarged bilateral axillary lymph nodes. Rash dissipated by 3/14/21. Still have tight right throat feeling. Still on 6 mg medrol. Still have left shoulder and clavicular discomfort, intermittent tingling both hands and right leg, muscular weakness and fatigue.
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| 65 | 2021-03-20 | pain in extremity, feeling cold |
Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. T...
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Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. Through the night then experienced the following: Muscle and joint pain, in shoulders and collar bone, elbows, hands and fingers. Hips, legs, and extreme hot feeling in knees with an extreme throbbing pain that lasted briefly. Then same hot throbbing pain in soles of feet, briefly. This followed by sharp stabbing pain in right heel, that also was a brief passing sensation. The following day, used Tylenol for headache. Felt extremely cold, especially hands. Continued with knee and ankle soreness. By mid day on 3/21. Felt more normal.
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| 65 | 2021-03-20 | facial pain, tingling |
Two weeks after 2nd Covid shot (3/17), a couple of blemishes appeared on rt. cheek of face. Started ...
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Two weeks after 2nd Covid shot (3/17), a couple of blemishes appeared on rt. cheek of face. Started to experience intense pain in lower jaw. Saw the dentist on 3/18 to rule out a tooth issue. Dentist found a small crack in lower molar & crowned it that day. He felt that was the issue. The following day, more blemishes/blisters appeared on cheek & face. More pain was experienced radiating from ear, across cheek & in the mouth. Saw the Dr. on 3/19 & was diagnosed with Shingles. Prescribed Valacyclovir HCL & Prednisone. Now (3/21), the blisters are prevalent on my eary, running across the cheek, chin, lower lip, tongue & gums. Pain is intense -stabbing, tingling & itching.
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| 65 | 2021-03-21 | pain in extremity |
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec...
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delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
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| 65 | 2021-03-22 | migraine, tingling, slurring |
Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 ...
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Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 with acute dysarthria thought to be due to complex migraine. MRI was negative for stroke. Additionally she had accelerated hypertension. She reports that migraines have not been a problem for 10 years prior. Hypertension has been an ongoing issue.
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| 65 | 2021-03-22 | pain in extremity, tingling, muscle spasms |
Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and s...
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Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and smell, which passed within 5 minutes. In those 5 minutes the next thing was tingling in her face, cheeks, lips and her sinuses which were not clogged up at the time cleared, which stayed that way until Saturday morning. She did have tingling and numbness in her fingers, but nothing in her feet, and did not extend beyond her face and cheeks. Then 20 minutes later at 1:55 PM her tongue became sort of thick and a little numb, but did not swell. The area between her tongue and mouth tightened and her jaw tightened but nothing swelled. No itching in the throat. She had some sort of aching like menstrual cramps but has had a hysterectomy. She did also have a headache, took a Tylenol at 2:15 and went to sleep. When she woke up had fatigue, sore arm, and everything else had passed other than the lips feeling prickly and numb. The tongue was no longer tight or in the jaw. Just still had the open sinuses and the headache. The most significant thing was the thickness and lack of feeling of her tongue. By Saturday she was fine other than the normal side effects, soreness of arm, no red rash, but had been moving it around.
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| 65 | 2021-03-22 | pain in extremity | Left arm soar and red circle size of a large pancake |
| 65 | 2021-03-22 | tenderness |
Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the inject...
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Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the injection on Saturday and I woke up this way on Sunday morning
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| 65 | 2021-03-23 | weakness |
Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headache...
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Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headaches, felt at times I might have been having a heart attack, very hard to breathe deep & felt like chest constricting. Lasted for a full 5 days.
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| 65 | 2021-03-23 | feeling of body temperature change |
Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part o...
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Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part of Sunday . Had hot and cold chills through Sunday. Legs and arms were feeling fatigue. Started eating again by Monday afternoon. Tues just arms and legs feeling like wet noodles. Today Wednesday feeling 50% better then day before.
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| 65 | 2021-03-23 | pain in extremity |
Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started ha...
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Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started having a bounding rapid heart beat; SOB/Shortness of breath; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199 and expiration date not provided), via an unspecified route of administration first dose on 07Mar2021 at single dose for Covid-19 immunization. The patient's medical history included allergy history to a of number of medication and things (I'm prone to allergies). The patient's concomitant medications were not reported. On 07Mar2021, the patient received the first dose and she went to sit in the observation area for 5 minutes. The patient was not anxious at all about getting it but she started having a rapid heart rate/ bounding rapid heart beat and SOB/shortness of breath that lasted about a minute. The EMT checked her out and asked her to stay longer and she did and after about 5 more minutes the same thing happened again. These episodes lasted about 1 minute and she had dizziness with it. Also she did not have any further episodes and she stayed a long time. Her concern was whether this was indicative of an allergic reaction and should she still get the second dose. The patient was asking for information about 2nd dose being given after 42 days. The patient stated that she has not had any more of those symptoms at all. The patient arm was sore and swollen that was all now. The events heart rate increased, dyspnea, pain in extremity, and peripheral swelling was assessed by the reporter as serious (medically significant). The outcome of the events heart rate increased, dyspnea, and dizziness was recovered and unknown for the remaining events. Information on Lot/Batch number was available. Additional information has been requested.
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| 65 | 2021-03-23 | pain in extremity |
Reports soreness in her arm, spinal column and neck. She said her neck is still not ?right? followin...
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Reports soreness in her arm, spinal column and neck. She said her neck is still not ?right? following her vaccine
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| 65 | 2021-03-24 | night sweats, breast pain, pain in extremity |
On-set on dizziness, severe pain and swelling in left arm. 6 hour later, severe pain shooting up my ...
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On-set on dizziness, severe pain and swelling in left arm. 6 hour later, severe pain shooting up my arm, radiating up my neck to my left ear. Severe pain on left side of chest, left breast and pain radiating over shoulder to back on left side. On scale of 1-10, the pain was a 9. Extreme heaviness on both sides of chest. I could breath but seemed difficult to take deep breaths. Took an extra dose of my blood pressure meds and it eased the pain to a 4-5 and I was finally able to sleep at 1:00 AM. Starting on March 8, 2021 I began having severe night sweats and continue to have them at present (March 25, 2021). Dr does not recommend that I take the second vaccination due to my reaction to the first one. He did recommend that I take the Johnson & Johnson but the health department is stating that I have to complete my vaccinations with the same on I started with. I will not have the second Pfizer.
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| 65 | 2021-03-24 | cold sweat | Patient reported feeling dizzy, light headed, clammy and warm with mild shortness of breath |
| 65 | 2021-03-24 | difficulty speaking |
Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip;...
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Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip; minimal raspy voice/Mild hoarseness; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 25Feb2021 13:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation . Medical history included diabetes mellitus from 2017 (Diabetes diagnosed 4 years ago) , obesity (Obesity has been 10 years or more) , hypersensitivity (Allergies for lifetime) , arthritis (Arthritis diagnosed 20 some years ago) , hypertension from 2011 (High blood pressure diagnosed 10 years ago) , depression (Depression diagnosed 30 years ago) , breast cancer female from 2019 , breast conserving surgery. Concomitant medication included anastrozole (ANASTROZOLE) taken for breast cancer. The patient experienced terrible laryngitis on 28Feb2021 with outcome of not recovered , fatigue on 01Mar2021 with outcome of recovering , sinus drainage with cough on 04Mar2021 09:00 with outcome of not recovered , post nasal drip on 2021 with outcome of unknown , minimal raspy voice/mild hoarseness. All the reported events were considered Important Medical Events. Course of the events: the patient received the vaccine on 25Feb2021, and 3-4 days after, she started getting terrible Laryngitis. It is a little better. She also was fatigued. She did not run a fever. She did develop a little sinus drainage and cough within the last 4 days. She can smell and taste. She called her doctor and he said it is a side effect or reaction to the COVID vaccine. She wanted to know if that was likely or if there had been reports of any others having this reaction. He told her not to get second vaccine. The patient was difficult to understand due to minimal raspy voice. Follow up information has been requested; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-03-24 | tremor, seizure |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: H...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Medium
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| 65 | 2021-03-24 | pain in extremity, numbness and pain in extremities |
The patient states that her neuropathy was "set on fire" after receiving the first dose of the Pfize...
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The patient states that her neuropathy was "set on fire" after receiving the first dose of the Pfizer. She said it was extremely bad and painful in her arms below her elbow. She was barely able to use her hands.
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| 65 | 2021-03-25 | discomfort, pain in extremity |
Had first dose at vaccination site on March 3rd. Upon arriving home, was unable to raise arm forwar...
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Had first dose at vaccination site on March 3rd. Upon arriving home, was unable to raise arm forward and upward. Pain described as aching. Not any relief with Tylenol or Ibuprofen. Thought on the 21st it was getting better, but on the 23rd was getting ready to go to the store felt like "both shoulders being pressed upon" and also could feel in upper back/neckline "pressure and ache."
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| 65 | 2021-03-25 | numbness | Numbness in face and hands. This lasted off and on for the 21 days between shots |
| 65 | 2021-03-25 | weakness |
Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and s...
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Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and spend most of my time in bed. Sometimes I can sit up on the couch and watch TV. I have trouble concentrating and even talking to someone on the phone is exhausting. My brain is not functioning like it usually does.
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| 65 | 2021-03-27 | pain in extremity |
3/26 - afternoon onwards, mild arm soreness 11p fever 3/27 - 7a 100 degree fever & headache, remain...
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3/26 - afternoon onwards, mild arm soreness 11p fever 3/27 - 7a 100 degree fever & headache, remained at 99-100 through day 2p onwards blurry vision 7p Tylenol 11p normal temp of 97.6, no headache 3/28 - 7a no fever or headache, feeling normal except blurry vision 11a Tylenol, in hopes it would help blurry vision
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| 65 | 2021-03-28 | difficulty speaking, flushing, feeling hot |
30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat. ...
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30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat. Noted hoarseness of her voice. Brought to medical area where she then noted flushing, warmth of skin on face, neck, upper arms and chest. Slight nausea. On exam, no abnormalities except flushed skin. Vitals remained normal and stable. Monitored vital signs, had epi pen ready and elected to send her to ED via EMS for further monitoring, esp given her long hx of anaphylaxis. No other tx provided at site.
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| 65 | 2021-03-28 | weakness |
Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have ...
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Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have such a painful headache that I can't eat; Eye pain; Aversion to food/ can't eat; Constant watery diarrhea despite not much food/diarrhea I have so bad; Constant nausea; Utter and complete lassitude/ exhausted; Being in bed, low energy; Stomach upset; Cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female consumer patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 04Mar2021 16:00 as a single dose for COVID-19 immunisation. Medical history included, in the 1990's, was diagnosed with systemic sclerosis (limited, used to be called CREST scleroderma), pretty severe Raynaud's syndrome, telangiectases, fatigue and sometimes joint aches. Patient was healthy despite this. Patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medications in two weeks included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Feb2021 04:00 PM and felt unwell but went to work and was fine in 2 days. On 04Mar2021, it was very different, the patient began having symptoms within 4 hours after receiving vaccine at 9 o clock that night. The patient stated "symptoms worsened and it is one week today and I am still sick. My fever broke on Monday. I still have cruel, incapacitating headache, eye pain, aversion to food (extremely weird for me), constant watery diarrhea despite not much food, constant nausea, utter and complete lassitude, dehydration (hospitalized, 2 liters of fluids), pain meds and anti-nausea meds. I have missed a week of work and this is a serious issue for many. I am OK but using precious sick time." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient stated "I missed whole week to work and I'm still sick. I have had so many different symptoms and some have gone away like my fever is gone but I have such a painful headache that I can't eat, nausea and constant diarrhea, you get the idea. I'm not against the vaccine but I think it would be good if people like me, people that have had my experience know, I hope it's within the normal range, I still don't know I would love to talk to somebody and find out if what I am experiencing is in the normal range, but it's not, people saying they experience so far the kind of the level of being in bed, low energy, unable to eat, fever, headache, stomach upset, I didn't have a cold, I had respiratory, I had a cough that has cleared up. I was hospitalized yesterday with fluids to become hydrated. It's important for us, you know, I mean, I leave the work that not good, people need to be prepared, it should be sick time I think it's important there is a follow up, absolutely. I was very happy I got the vaccine but I am so sick and it's been a week today so, that's why I decided to call and I was in the hospital yesterday, getting fluids dehydrated and I was admitted (reason for hospitalization was not clarified). I wasn't admitted, I was in the hospital for the day on IV fluids, anti-nausea medication, pain medication also, 3 things they gave me in an IV. They sent me home but the diarrhea I have so bad, I'm exhausted, but I have to spent all my time in the toilet, I thought today might be, I might wake up it would be healing today but I'm still pretty sick." Outcome of fever and cough was recovered, and of remaining events was not recovered. The patient underwent COVID-19 virus test via nasal swab on 03Mar2021 with negative result. Information about lot/batch number has been requested.
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| 65 | 2021-03-28 | weakness, tremor |
then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feelin...
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then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
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| 65 | 2021-03-29 | pain in extremity |
Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous repor...
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Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered. There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-03-30 | weakness, speech disorder |
Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in ...
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Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.
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| 65 | 2021-03-30 | numbness, tingling |
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/n...
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hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
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| 65 | 2021-03-31 | pain in extremity |
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni...
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Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
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| 65 | 2021-04-03 | pain in extremity |
sore arm; severe headache; This is a spontaneous report from a contactable physician (self-Reported)...
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sore arm; severe headache; This is a spontaneous report from a contactable physician (self-Reported). A 65-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number: EL9262) via an unspecified route of administration in Arm Left on 25Jan2021 09:30 as single dose for covid-19 immunisation. Medical history included atrial tachycardia and asthmatic bronchitis. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm and severe headache. The outcome of the event was unknown.
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| 65 | 2021-04-04 | muscle spasms |
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in lef...
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After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
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| 65 | 2021-04-04 | muscle spasms |
I had muscle spasms, cramping and aching cause lots of anxiety lasting a week intermittent not consi...
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I had muscle spasms, cramping and aching cause lots of anxiety lasting a week intermittent not consistent. I went to ER for muscle spasm and heart burn prescribed medication and follow up with my doctor.
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| 65 | 2021-04-07 | muscle spasms, numbness and pain in extremities |
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and musc...
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Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
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| 65 | 2021-04-07 | breast pain, difficulty speaking |
anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a str...
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anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a straw, narrowing airway; Sensation of throat closure/narrowing of airway; significant shortness of breath/difficult to breath like through a straw; Pain in both lymph nodes, under both the armpit; Pain in both breasts; Dry cough; Itching, airway/trachea itchy; Hoarseness; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the left deltoid on 15Feb2021 at 15:30 as a single dose for protection against Covid. Medical history included ongoing obesity as she gains and loses it, ongoing hypertension, ongoing asthma (at 59 she was bumped up to moderate degree asthma), ongoing significant food allergies, was born with and had ongoing eczema so she was allergic to milk (was given soy milk since she could not tolerate milk, when she drank milk, it produced phlegm/caused increase in mucus, ongoing significant environmental allergies wherein she would have allergies in the fall, from August through September and would have sneezing, congestion and itchy watery eyes. The patient also had a history of getting bronchitis but has not had it for a long time. The patient got stung by a bee when she was 40ish and her upper thigh got red, itchy and it lasted for 10 days and she and no other symptoms and was now careful around bees. The patient reacts to the smoky matches that blow out and make smoke, from the sulfa in the matches, fireplaces, wood burning and firepits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported and fluticasone (manufacturer unknown) taken for asthma and allergies, start and stop date were not reported. The patient was on significant medications for her asthma, allergies and blood pressure. The patient previously got a flu shot at the end of Oct2020. The patient also previously took Aleve in her early 40's and was taking them for a neck injury for 2-3 months and at the end of the treatment she broke out in a rash. The patient also previously took aspirin 3 years ago and broke out in a rash. The patient also has an albuterol inhaler but has not taken it for years. The patient was careful, handwashing normally, wipes the shopping carts as they are germy. The patient stated that after receiving the vaccine, one main event was terrible airway swelling, itching and it was difficult to breathe. The terrible airway swelling felt like breathing through a straw and narrowing airway. She stated that it started 18.5 hours after the vaccine, on 16Feb2021 at 10 am and lasted for 4 hours between 10 to 2 pm. The patient also had itching wherein her airway and trachea were itchy which also started on 16Feb2021 at 10 am to 2 pm. The patient experienced narrowing of airway and sensation of throat closure also between 10 am to 2 pm. The patient also experienced that it was difficult to breathe but she did not feel like she needed to go to the hospital. If it got any worse she would gave went to the emergency department. She stated that she was sitting up, walking around and she would have had a significant shortness of breath and she was trying to wait it out. It was difficult to breath like through a straw which also started from 10 am to 2pm. She did not feel like she wanted to walk or do daily activities. She was on the phone with her mother and her mother could hear her difficulty in talking and her heavy breathing. The patient also experienced pain in both lymph nodes, under both armpits and pain in both breasts which started also on 16Feb2021 at 10 am and lasted for 24 hours the 10 am the next day. The patient had dizziness which started about noon and when she woke up the next day it as gone which she considered as medically significant since she is never dizzy and it was not due to her blood pressure and she has been on pills for a long time. The patient had dry cough and hoarseness also on 16Feb2021 from 10 am to 2 pm. The patient was afraid to take the second vaccine and she spoke to her pulmonologist who knows her history and was told that she would benefit. She thought that if she felt bad, she would go to the emergency room if it got worse but it did not. The patient stated that she thinks these reactions are allergic, the itching and narrowing of throat can be anaphylactic. The patient did not require any medical intervention and was not seen in the emergency department and was not hospitalized. The events lasted for 4 hours and stayed at that level. The patient did not get any treatment and it went away. The outcome of the events terrible airway swelling, it felt like breathing through a straw, narrowing airway, Dry cough, Itching, airway/trachea itchy, Hoarseness, Sensation of throat closure/narrowing of airway, reactions are allergic and anaphylactic was recovered on 16Feb2021 at 14:00. The outcome of dizziness was recovered on 17Feb2021 and the outcome of pain in both lymph nodes, under both the armpit and pain in both breasts on 17Feb2021 at 10:00. The patient reported that the events were considered as medically significant. The relatedness of the drug to the reactions from primary source reporter (method of assessment: Global Introspection) for the events was related.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded since it is part of the product safety profile. Potential contributors include patient's advanced age, as well as underlying obesity, hypertension, asthma, eczema, multiple allergies and other co-morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-07 | speech disorder |
she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling...
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she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-04-08 | weakness |
On Apr. 3 I had vertigo and fell on my back in the bedroom. 15 minutes later I started vomiting and ...
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On Apr. 3 I had vertigo and fell on my back in the bedroom. 15 minutes later I started vomiting and nausea and then went to the Emergency room. Hospitalized for 5 days. Discharged on Apr. 7 but still very weak and need help getting up or lying down.
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| 65 | 2021-04-10 | one side paralysis, weakness |
Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever...
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Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever. Weakness,chills and fatigue and headaches progressed until 4/01/2021 when patient experienced complete weakness in left arm and leg and unable to stand or walk. Prior to 2nd dose, patient was recovering from a stroke and was beginning to walk with assistance and a cane. After April 1, 2021, patient is unable to stand or walk. Chills, headaches weakness and fatigue continue as of April 11, 2021
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| 65 | 2021-04-14 | weakness |
Severe diarrhea starting the evening after having received the vaccine in AM. Diarrhea severe for Fr...
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Severe diarrhea starting the evening after having received the vaccine in AM. Diarrhea severe for Friday and Saturday. Patient became weak late on Saturday and husband insisted on trip to ER late in the evening and patient presented in hypovolemic shock with hepatorenal syndrome and severe metabolic acidosis and eventually to include lower GI bleed heralding ischemic colitis and requiring subtotal colectomy. Colon surgery complicated by post-op oozing and return to the OR. Returned stabilized. Has now progressed to SNF for recovery with Ileostomy and generalized weakness and blood loss anemia.
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| 65 | 2021-04-15 | pain in extremity |
About a week after my first shot, the middle joint of my fifth finger on my left had became sore, es...
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About a week after my first shot, the middle joint of my fifth finger on my left had became sore, especially upon touch. It also stiffined. About a week after my second shot, the middle joint of my fourth finger became sore, especially upon pressure and is somewhat stiff. I have no history of any type of arthritis nor is it in my family. I had no problems with my fingers on either hand prior to the vaccinations. I play piano and never had any pains nor stiffness.
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| 65 | 2021-04-15 | weakness |
Lip numbness and tingling. Throat tightness. Weakness. Heart rate dropped to 42 bpm. Facial and ...
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Lip numbness and tingling. Throat tightness. Weakness. Heart rate dropped to 42 bpm. Facial and lip swelling. No SOB, no chest pain.
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| 65 | 2021-04-18 | night sweats | High fever, severe night sweats, blood clots in lungs |
| 65 | 2021-04-20 | weakness |
Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weaknes...
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Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative. She was discharged w/dexamethasone and pulse oximeter. Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.
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| 65 | 2021-04-23 | weakness |
Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and...
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Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and fatigued; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Deltoid Right on 28-JAN-2021 16:00 at single dose for COVID-19 immunisation. Patient medical history included COVID-19 Virus and diabetes runs in family, but she just had a physical. Patient did not have diabetes. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29 Jan2021, the patient had experienced very weak and fatigued very weak and fatigued. On 30 Jan 2021, the patient had experienced sharp pain on her left eyelid. On 31 Jan 2021, the patient had experienced left eyelid swollen and purple. Next COVID-19 Vaccine in 18Feb2021. The patient did not received other medications within 2 weeks of vaccination. Patient was not on any prescription or over the counter medications. She took Eye Relief Eye drops and Benadryl for her eyelid swelling. Benadryl and Eye Relief eye drops did not do anything for swollen eyelid. Provided, lab-1451-1.0, on back of fact sheet for recipients and caregivers. On an unspecified date in 2021 the events sharp pain on her left eyelid and very weak and fatigued was resolved. At the time of reporting, the outcome of the event left eyelid swollen and purple was not recovered..
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| 65 | 2021-04-24 | cold sweat |
blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; ...
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blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 65 | 2021-04-25 | numbness, pain in extremity, feeling cold |
On 4/7/21, Wednesday, client received the second Pfizer Covid-19 vaccine with lot number ER8729 at 1...
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On 4/7/21, Wednesday, client received the second Pfizer Covid-19 vaccine with lot number ER8729 at 1336. Client presented to EMT complaining of right shoulder pain at 1410 with the following vital signs; blood pressure of 128/88, pulse of 68 and 97% oxygen saturation on room air. RN was brought to client in observation area for further evaluation. No medical history or medications were noted. Patient further reported numbness and a ?cold sensation? in the arm that received the vaccination. RN's focused assessment of arm noted arm was non-tender, no discoloration, or swelling; patient did not appear to be in any distress with stable vital signs. Patient advised to inform EMT if any other symptoms presented and to wait an additional 15 minutes. Vital signs at 1425 were a blood pressure of 128/88, pulse of 68, and oxygen saturation of 99% on room air. No medications or interventions were indicated or administered. Client refused EMS and left site in good disposition agreeing to consult with medical provider if symptoms persisted or worsened.
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| 65 | 2021-04-26 | pain in extremity | Severe swelling in both arms and knees. Pain in back of neck into both arms and hands. Headache |
| 65 | 2021-04-27 | weakness |
April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vacci...
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April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is "septic shock secondary to ischemic bowel & intra-abdominal sepsis". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages.
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| 65 | 2021-04-28 | seizure, muscle spasms |
Spasms in left arm; Went to ER bc I thought it was a seizure; This is a spontaneous report from a co...
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Spasms in left arm; Went to ER bc I thought it was a seizure; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65 years, via an unspecified route of administration, administered in Arm Left on 20Jan2021 (Batch/Lot Number: EL3247) as a single dose for covid-19 immunization. Medical history included cancer from an unknown date and unknown if ongoing. Concomitant medications included levetiracetam (KEPPRA); mesalamine; prednisone; and folic acid, all taken for an unspecified indication, start and stop date were not reported. In Jan2021, the patient experienced spasms in left arm and went to ER because she thought it was a seizure. The patient was hospitalized due to the events for 2 days. The patient underwent lab tests and procedures which included negative test for Covid-19 on 26Mar2021. The outcome of the events was recovered with sequelae
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| 65 | 2021-04-28 | seizure, muscle spasms, numbness |
Spasms in left arm; ultimately leading to the left arm becoming completely numb after 2nd dose; went...
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Spasms in left arm; ultimately leading to the left arm becoming completely numb after 2nd dose; went to emergency room because she thought it was a seizure; shortness of breath ever since 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 14Feb2021 (at the age of 65 years old) (Lot Number: EM9810) as single dose for COVID-19 immunisation. Medical history included cancer. The patient was not pregnant at the time of vaccination, had no known allergies and did not have COVID prior to vaccination. Concomitant medications included levetiracetam (KEPPRA), mesalamine, prednisone and folic acid; all taken for an unspecified indication, start and stop date were not reported. The patient had her first dose of BNT162B2 on 20Jan2021 for COVID-19 immunization and experienced spasms in left arm and seizure. No other vaccines were administered within four weeks. In 2021, patient experienced spasms in left arm, ultimately leading to the left arm becoming completely numb after second dose. Patient went to emergency room because she thought it was a seizure. This happened twice. She also had shortness of breath ever since second dose. The events resulted in hospitalization for two days from an unknown date in 2021. It was unknown if any treatment was given. The patient recovered with lasting effects The patient underwent COVID-19 test (nasal swab) with result of negative on 26Mar2021 (post vaccination). The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-04-28 | bell's palsy |
stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored p...
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stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 16Mar2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included a mild case of COVID-19, last year, on an unspecified date in 2020. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID vaccine. On 21Mar2021, the patient's face sunk in and changed. The patient's symptoms were not improving. Her eye and right side of her face are affected. She cannot close her right eye. She worked on it and is now able to close right eye not like the left eye closes, but it doesn't blink as the left eye does. She has been using eye drops for this. She said it was Bells Palsy. The patient added that it is hard to look in the mirror. She will not get the second dose. She was not interested in taking the vaccine now. She wanted to wait and see. It being so new and see. Her sister took it and encouraged her, and said it is necessary because they like to travel. She got Prednisone when she was at the hospital, they gave her 60mg Prednisone. Her physician didn't want to keep her on it too long and said it may cause other complications. Her physician cut her off, she weaned her down 50mg, 40mg, 30mg, 20mg, then 10mg. When the patient noticed her face start to turn, she went to the ER. She thought she was having a stroke. The patient was not admitted to the hospital. The outcome of the event face sunk in and changed/bells palsy was not recovered while the outcome of the event stroke was unknown.
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| 65 | 2021-05-03 | cold sweat |
cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness a...
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cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body, pain not quellable with Tylenol headache sensitive glands all lasting about 12 hours this was my 2nd dose, first dose had no effects except for site soreness
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| 65 | 2021-05-04 | muscle spasms |
Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Sh...
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Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21
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| 65 | 2021-05-04 | tingling, burning sensation, bell's palsy |
it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and ...
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it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
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| 65 | 2021-05-04 | tingling, difficulty speaking |
kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full...
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kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-05-04 | pain in extremity |
leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpita...
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leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpitation; light headed/dizzy; severe muscle pain; tenderness and soreness in her inner thigh of the left leg/throbbing pain; Chills; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration in unspecified arm on 09Mar2021 (12:00) at single dose for Covid-19 immunization. The patient's medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine been taking for 10-11 years for hypothyroidism. On 17Mar2021, Wednesday, the patient received the vaccine and had chills. On 18Mar2021, the patient had tenderness and soreness in her inner thigh of the left leg. On 19Mar2021, the patient had severe muscle pain on her calf of leg to inner thigh and it was throbbing so bad behind her knee on her left leg that she called her physician, and a sonogram was performed on 23Mar2021 which had found there was not a blood clot but there was severe inflammation along the major vein in her leg. On 20Mar2021, the patient had heart palpitation, her doctor told her to drink water and propel, she had heart spasms for 6 hours and felt lightheaded and dizzy. she thought she would go to the hospital, but she lives in a rural community and felt it did not make sense to go to the hospital. Palpitations and tenderness recovering. Her doctor and she was put on a heart monitor for her heart palpitations. She had heart palpitations with her hypothyroid but, this was totally different when she has had heart palpitations in the past. On an unknown date in Apr2021, the patient had diarrhea for 6 days. Patient had not been back to the doctor, but the nurse thought it was ok for her to take the second vaccine, but the patient was not comfortable with it. No prior vaccinations within the week. The patient never taken the flu shot. She had never received the flu vaccine or pneumonia nothing, so this was new for her getting the COVID vaccine. Caller clarified the chills started the week after she received the vaccine on Wednesday 17Mar2021. Severe muscle pain: Caller stated this happened on the 19, 20, 21, and 22 as well as the throbbing pain and then the next day on Monday 22Mar2021 she went to call her doctor and had a sonogram that next day on Tuesday (23Mar2021). Caller stated she still had the muscle pain in her left leg on the inner thigh but it was more so when she was active and once in a while she felt like her leg was bruised for a day or two but then it went away and she did not have a blood clot. Left leg throbbing: Caller stated this continually got worse and then on Sunday she felt so bad she laid in bed with her knee up and it throbbed like crazy. Caller stated this stopped about 2 days after she got the sonogram and it was not that severe it was just really tender and sore. Heart palpitation: Caller clarified that the heart murmurs she referred to earlier was actually heart palpitations. Caller stated this started at 8 in the morning and then at 10 in the morning she started getting light-headed and thought about going to the emergency room and figured no she will get through this. Caller stated she called her physician for the heart palpitations on Monday and she saw her doctor the following Tuesday and that is when her doctor had given her the heart monitor. Caller stated for 6 hours she felt horrible on Saturday since she knows the difference from her normal heart palpitations from her thyroid. Diarrhea: Caller stated this last for 6 days and was last week or so. Treatment: Caller stated no she is not a medicine taker she does not even take Tylenol or Advil unless it is a necessity. Outcome of the event chills recovered on 18Mar2021, tenderness and soreness in her inner thigh of the left leg/throbbing pain was resolving, severe muscle pain and inflammation along the major vein in her leg was not resolved, heart palpitation was resolving, light headed/dizzy was resolved on 20Mar2021, diarrhea was resolved on Apr2021, leg was bruised was resolved, heart spasms was unknown. No follow-up attempts are needed. No further information is expected. follow up(20Apr2021): New information was reported from a contactable consumer (patient) included: new events (coronary spasm, pain in extremity, phlebitis lower limb and bruising of leg) and event details. Case is upgraded to serious upon this follow up. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-05-07 | facial pain, facial paralysis |
I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I h...
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I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I had like a headache on my left side.; inside of my mouth just started moving; It scared me; had side of my face was sore; I had my head hurt and I am like, my neck, oh my god, what's going on; I had my head hurt and I am like, my neck, oh my god, what's going on; it's wiggling like it and while I am breathing there is a time I go like (consumer imitates like breath-ing is stopped) and then breathing normally; This is a spontaneous report from contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 02Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history included high blood pressure and Sinus. The patient's concomitant medications included metoprolol (blood pressure), amlodipine (blood pressure), diazepam and gabapentin (problem with my leg). The patient reported on an unknown date, that she was having a reaction and got her second shot over three weeks ago. The patient experience last night was not just having bad, my mouth was moving out of control, it was like wiggling and stopping wiggling and stopping, it did all the night and up my mouth on my left side is moving, it's wiggling like it and while I am breathing there is a time I go like (consumer imitates like breathing is stopped) and then breathing normally, face just moved on it's own, it did a few time but last night which it, did it to the moment it kept doing it, kept doing it and then had like a headache on my left side. Patient was trying to sleep, for today this morning, inside of my mouth just started moving, You know, fast, fast and air coming out and this woke me up and now things started again and air coming out, oh my god, It scared me and noticed that when I am sitting up or laying it coming up and then it go back to normal. Patient had side of her face was sore and they did it so fast and quick, could hear doing stop and had my head hurt and I am like, my neck, oh my god, what's going on. Patient at the hospital had Ultrasound and X ray done. Patient took Tylenol. The outcome of the events was reported as unknown. Follow up#1 (PRD 25Apr2021, SRD 26Apr2021): This is a follow up spontaneous report from a 65-year-old female contactable consumer. This consumer (patient) reported information included concomitant medication, medical history, events, outcome, lab data. Follow up attempts are needed. Further information has been requested.
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| 65 | 2021-05-07 | facial pain |
Ramsay Hunt syndrome; excruciating pain on the left side of my face. Especially deep within my left ...
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Ramsay Hunt syndrome; excruciating pain on the left side of my face. Especially deep within my left ear; This is a spontaneous report received a contactable consumer, the patient. A 65-year-old [non-pregnant] elderly female received the first dose of BNT162b2 (solution for injection; Lot EWO162 and expiry information not provided) as a single dose via unspecified route in the left arm on 12Apr2021 at 08:15 (at 65-years-old) for COVID-19 immunisation. Relevant medical history included Hashimoto's disease, Irritable Bowel Syndrome (IBS), and sulfonamide allergy. Concomitant medications sans therapy dates included levothyroxine sodium (SYNTHROID). The patient denied COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 19Apr2021 at 12:00, reported as exactly one week after receiving the vaccine, the patient began to experience an excruciating pain on the left side of her face, especially deep within her left ear. The patient described that it felt like someone was jabbing her with an ice pick in her ear. The patient reported that it was still bad the next day and then subsided a little. The patient went to the doctor on 23Apr2021 where she was diagnosed with Ramsay Hunt syndrome. The patient reported that she had some other side effects shortly after she received the vaccine, but they were nowhere near as bad as this (pending clarification). The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient denied any COVID testing since receiving the vaccine. Treatment for the events included valacyclovir. The outcome of the events vaginal pain, excruciating pain on the left side of her face, and Ramsay Hunt syndrome, was not recovered.
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| 65 | 2021-05-09 | pain in extremity |
My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh...
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My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh, left knee and left calf whenever I sat, walked, went up and down stairs, while sleeping and I was limited in what activities I was able to do without pain. I went to the doctor on 3/29/2021 (9 days after my first shot) and the doctor sent me for an ultrasound of the left leg and an X-ray of the left ankle..
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| 65 | 2021-05-10 | pain in extremity |
Whole Leg Pain after first dose of Covid Vaccine/hurt in her thighs, knees, calves, and down into he...
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Whole Leg Pain after first dose of Covid Vaccine/hurt in her thighs, knees, calves, and down into her ankles; Lower back sore intermittently/The back pain fluctuates from a pressure and mild ache to soreness; This is a spontaneous report from a contactable other nurse (patient). A 65-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in Deltoid Left on 29Mar2021 10:30 (Batch/Lot Number: ER8727) as First Dose; Left Deltoid for covid-19 immunization. Vaccination facility type was in pharmacy. No vaccines administered on same date of the Pfizer suspect. None prior vaccinations within 4 weeks. Family medical history relevant to AE was none. Medical history included ongoing high cholesterol diagnosed about 30 years ago (it was hereditary), ongoing Hashimoto's thyroiditis diagnosed about 20 years ago. Concomitant medications included rosuvastatin taken for blood cholesterol from about 3 years ago in 2018 to Apr2021 (a few weeks after the first dose of the vaccine); levothyroxine sodium (UNITHROID) taken for Hashimotos thyroiditis and ongoing. Patient was not on any other cholesterol medication currently. About 2 weeks after the first vaccine she started having leg pain. It was whole leg pain. It hurt in her thighs, knees, calves, and down into her ankles. She went to her doctor who did doppler studies and found no blood clots in Apr2021. Thought maybe it was the cholesterol medications that she had been on for years; so she stopped taking it. The pain in legs subsided a few days later and ended a few days before she got the second vaccine. She was a hiker and was in amazing shape. She had not done anything different, nothing that would have exacerbated this. She believed her symptoms are medically significant as she did not know for sure what was causing them. She was uncertain if her symptoms have been caused by the Covid Vaccine. The event whole leg pain after first dose of Covid Vaccine required a visit to physician office. No emergency room visited. She had issues with her back. She noticed something new. Her lower back was sometimes sore. It came and went intermittently; unlike the leg pain that was constant. The back pain fluctuates from a pressure and mild ache to soreness. This also occurred after both vaccines. The outcome of back pain was not recovered, of other event was recovered in Apr2021. The reporter (patient) was uncertain if her symptoms have been caused by the Covid Vaccine.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pain in extremity","Back pain" and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021467940 same patient/drug, different vaccine dose/AE
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| 65 | 2021-05-10 | pain in extremity |
Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurre...
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Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurred after both vaccines.; Leg pain making it hard to sleep; This is a spontaneous report from PPDi. A contactable nurse reported herself that a 65-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Deltoid Right on 20Apr2021 10:15 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, with Age at Time of Vaccination at 65 years old. Medical history included ongoing blood cholesterol increased (Verbatim: High cholesterol. Stated she was diagnosed about 30 years ago. Said it was hereditary), ongoing autoimmune thyroiditis (Verbatim: Hashimoto's thyroiditis. Stated she was diagnosed about 20 years ago). Historical vaccine included first dose of Covid Vaccine (Batch/lot number: ER8727) on 29Mar2021 given at 1030, at Left Deltoid and experienced whole leg pain (about 2 weeks after the first vaccine she started having leg pain). Concomitant medications included rosuvastatin taken for blood cholesterol from an unspecified start date to Apr2021 (reported as Started medication about 3 years ago. Stopped a few weeks after the first dose of the vaccine, was not on any cholesterol medication at this time); levothyroxine sodium (UNITHROID) taken for autoimmune thyroiditis from an unspecified start date and ongoing. The patient experienced whole leg pain after second dose of covid vaccine (medically significant) on Apr2021 with outcome of not recovered, lower back sore intermittently (non-serious) on Apr2021 with outcome of not recovered, leg pain making it hard to sleep (non-serious) on Apr2021 with outcome of unknown. The patient underwent lab tests which included ultrasound doppler: no blood clots on Apr2021. Reported she went for her second vaccine and about 5 days later the leg pain came back. Said she took Tylenol and Motrin, nothing helps the pain. Said her legs have been hurting for about 4 days now. Stated that her pain seems unusual because it goes all the way down into her ankles and travels back and forth. Caller stated that she was a hiker and was in amazing shape. She had not done anything different, nothing that would have exacerbated this. Caller states she retired after being a Licensed Practical Nurse for 30 years in 2019. Caller stated that the leg pain after her first vaccine started about 2 weeks after the vaccine and lasted for about a week. Said it ended a few days before she got the second vaccine. Caller stated that her leg pain after the second vaccine was ongoing. Said that she got the vaccine on a Tuesday and her legs started to hurt again around Friday. Said that was effecting her life. Her legs hurt in every position. It was making it hard for her to sleep. Stated she believed her symptoms were medically significant as she did not know for sure what was causing them. Later in the call the caller mentioned that she had issues with her back. Said she noticed something new. Her lower back was sometimes sore. It comes and goes intermittently; unlike the leg pain that was constant. Stated the back pain fluctuates from a pressure and mild ache to soreness. This also occurred after both vaccines. Treatment received included: Tylenol and Motrin that did not offer any relief for her leg pains: Tylenol Extra Strength 500mg; P121876; Expiration Date: Sep 2023. Stated she took 2 tablets at a time. Motrin 200mg; 0GE2545A; Expiration Date: Mar 2022. Stated she took 2 tablets at a time. Causality: Stated she was uncertain if her symptoms have been caused by the Covid Vaccine. Follow-up attempts have been completed.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination BNT162B2 played a contributory role in triggering the onset of the event pain in extremity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.,Linked Report(s) : 2021467913 same patient/drug, different vaccine dose/AE
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| 66 | 2020-12-31 | hot flush | Pain, soreness at injection site, flushed feeling. |
| 66 | 2021-01-03 | burning sensation | Patient developed painful hives, blisters, burning, itching |
| 66 | 2021-01-04 | weakness |
66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg ...
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66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.
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| 66 | 2021-01-04 | weakness, feeling cold |
Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I ...
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Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I get up, I get light headed; I had COVID back in March and I feel the same way I felt then except the breathing is normal; Very weak; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation . Medical history included blood pressure measurement on an unknown date. The patient had been up all night long freezing, shaking; had to take a hot bath just to warm up on 24Dec2020 with outcome of unknown , every time she got up, she got light headed on 24Dec2020 with outcome of unknown , she had Covid back in March and she felt the same way except the breathing is normal on 24Dec2020 with outcome of unknown , very weak on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Mar2020. Information about Lot /batch number has been requested.
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| 66 | 2021-01-05 | pain in extremity | SORE ARM |
| 66 | 2021-01-05 | cold sweat |
Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward aro...
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Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.
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| 66 | 2021-01-06 | numbness |
Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recu...
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Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via unspecified route of administration on 29Dec2020 13:30 on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included Hypertension, Reflux and low back pain. Concomitant medications included ibuprofen, dicycloverine hydrochloride (BENTYL), Valsartan and omeprazole. The patient previously took codeine, Bactrim, Zyrtec and experienced allergies. The patient experienced Right sided facial and top lip Numbness, recurring pain on 31Dec2020 16:00. All events resulted in emergency room visit and Hospitalization on 31Dec2020 for 1 day. The patient underwent lab tests and procedures, which included Cat scan, MRI, ultrasound of heart and labs on unspecified dates, Nasal Swab/Covid 19 test on 01Jan2021 with negative result. The outcome of the events were not resolved.
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| 66 | 2021-01-07 | feeling hot |
Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had...
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Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had fever and felt like kind of warmish; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0140), via an unspecified route of administration, on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergy, brain aneurysm, psoriasis, diabetic, blood pressure, immunosuppressant, cholesterol, and stent in brain. The patient's concomitant medications included metformin, semaglutide (RYBELSUS), valsartan for blood pressure, acetylsalicylic acid (ASPIRIN), ustekinumab (STELARA) as immunosuppressant for psoriasis, and an unspecified statin for cholesterol. The patient took the COVID vaccine yesterday morning (30Dec2020) at the hospital and she had like a pounding heart rate, it is faster than normal, but it is pounding. The patient can hear her heartbeat in her ears. The patient took her blood pressure and it is normal at 123/78 something like that. Heart rate is an over - little 72, 75, little bit fast but not tachycardia. The patient felt like she had fever and felt like kind of warmish, but her temperature is 98.2. As treatment, the patient took an over-the-counter medication, paracetamol (TYLENOL). The outcome of the events was unknown.
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| 66 | 2021-01-07 | pain in extremity |
She verbalize she develop pain in left leg and dizziness. She was evaluated onsite by Fire Rescue a...
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She verbalize she develop pain in left leg and dizziness. She was evaluated onsite by Fire Rescue and released home feeling better at 9:51 am.
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| 66 | 2021-01-09 | muscle spasms | The concern was the gi symptoms,,,severe cramping nausea, vomiting and bloody stool |
| 66 | 2021-01-10 | weakness, pain in extremity |
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9...
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1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
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| 66 | 2021-01-11 | feeling hot |
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,...
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"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
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| 66 | 2021-01-11 | pain in extremity |
PATIENT HAD A SORE ARM ON THURSDAY. ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUN...
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PATIENT HAD A SORE ARM ON THURSDAY. ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUND THE SITE OF THE INJECTION. ON SUNDAY THE AREA WAS LESS SWOLLEN. ON MONDAY SHE CAME IN TO SHOW ME THE RASH. IT WAS A STRAIGHT HORIZONTAL LINE WITH RED PETECHIAE AROUND THE LINE, EXTENDING TO THE REAR ARM PIT AREA.
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| 66 | 2021-01-11 | numbness |
The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minut...
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The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away'; she felt 'a wave of nausea; This is a spontaneous report from a contactable consumer for herself. This 66-year-old female patient received the first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated 3 hours after having received the vaccine, she felt 'a wave of nausea that went away just as fast as it had hit' her. The left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away. This was on the same side that she got the vaccine. She had never experienced anything like that. The outcome of event face went numb was recovered. The outcome of other events was unknown. Information about Batch/Lot number has been requested.
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| 66 | 2021-01-11 | flushing |
Vaccine administered at 08:17am. At 9:10, patient felt flushed and dizzy and experience tingling in ...
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Vaccine administered at 08:17am. At 9:10, patient felt flushed and dizzy and experience tingling in mouth; patient was administered Benedryl orally at 9:20am. At 9:25, 911 was called and an Epi was administered that was available provided by on-site pharmacist. Patient was subsequently transported by local EMS to a healthcare facility.
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| 66 | 2021-01-12 | pain in extremity | Headache, generalized body aches/pain, pain in legs for 18 hours |
| 66 | 2021-01-13 | pain in extremity |
Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from ...
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Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 15Dec2020 15:00 (lot EH9899, expiry date not reported) in the left arm, then second dose on 05Jan2021 (lot EL0142, expiry date not reported); both via an unspecified route of administration at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had other medications (unspecified) in the two weeks prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 02:00, the patient experienced aching in arms and legs, and reported that after 2nd vaccine felt like patient had the flu. The patient did not receive any treatments for the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient recovered from the events aching in arms and legs and felt like patient had the flu in Jan2021.
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| 66 | 2021-01-13 | night sweats |
Day following: severe body aches, chills and fever and slight nausea. The second day following inje...
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Day following: severe body aches, chills and fever and slight nausea. The second day following injection felt a bit better but that evening night sweats and third day following quite nauseated.
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| 66 | 2021-01-13 | tremor | chills, shaking, headache, neck ache, joint pain, nausea, vomiting |
| 66 | 2021-01-14 | breast pain | Hardly can walk body aches right breast hurts |
| 66 | 2021-01-14 | pain in extremity, pain in extremity | Sore arm, headache |
| 66 | 2021-01-14 | pain in extremity | Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure |
| 66 | 2021-01-15 | muscle spasms |
about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomac...
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about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
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| 66 | 2021-01-17 | numbness, muscle spasms |
1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema...
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1/15/2021 11:00 p.m. developed orbital edema took Benadryl 75 mg PO. 1/16/2021 morning orbital edema improved but still present, shortness of breath, lips tingling, swollen tongue, facial numbness around mouth and cheeks. Benadryl 50 mg every 4-6 hours, Prednisone 10 mg, Tagement 1 pill (unknown dose), Afternoon developed GI symptoms cramping diarrhea took Bentil 20 mg 1/17/2021 Continued facial swelling Benadryl 50 mg 1/18/2021 Symptom resolution
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| 66 | 2021-01-17 | burning sensation |
Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea...
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Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain Benadryl 50mgm, Epinephrine, Observation,
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| 66 | 2021-01-17 | pain in extremity |
On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started...
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On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started to get real hard in the muscle. I took 2 naproxen and 2 tizandine. I could not use my left arm from 4:00 pm-10:00 pm. On 1/17/2021, I woke up and my left arm was real hard and I could not use my arm all day and night. I took 2 naproxen, 2 tizandine and 1/2 tramadol. On 1/18/2021, I woke up and my left arm is back to normal.
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| 66 | 2021-01-18 | tingling |
Patient had slight swelling in her hand and tingling at the injection arm. Patient took two Benadryl...
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Patient had slight swelling in her hand and tingling at the injection arm. Patient took two Benadryl 25 mg capsules and the swelling subsided. 15 minutes later, patient had swelling in both legs. An ambulance was called and patient was taken to urgent care to get treated. Patient was released from urgent care the same day and has recovered.
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| 66 | 2021-01-20 | migraine | Cough began 12/27/20 followed by severe migraine on 12/31/20. |
| 66 | 2021-01-20 | feeling hot, flushing | Patient reports facial flushing and warmth, lasting about 1-2 hours. |
| 66 | 2021-01-21 | numbness, flushing, tingling |
At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my...
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At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my throat, tingling, numbness of my face in around my mouth, red flushing of the skin in my upper chest and throat. I took 2 Benedryl tablets and experienced symptoms for the next hour. They subsided by 5:30 pm . I was able to breathe and swallow during the whole episode. I had very similar reactions several times in June when I was for unknown reasons experiencing hives and had same response when prescribed Bactrim, and then Keflex because of a UTI. I had no further incidents with the chest, throat, mouth reaction since mid June until yesterday. I had no adverse reaction to the vaccine until 3.5 hrs after receiving it. I feel this is because my body has some sensitivity, not that anything was done incorrectly in administration of the vaccine. All personnel were very attentive and careful that I observed.
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| 66 | 2021-01-21 | pain in extremity |
At the time of the injection was painful, hurt from that point forward and kept on hurting all day. ...
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At the time of the injection was painful, hurt from that point forward and kept on hurting all day. Yesterday started hurting in the shoulder and arm continued, still hurts today 1/22/21. Warm to touch, still warm to touch today, knot underneath armpit.
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| 66 | 2021-01-21 | seizure |
Patient recieved dose of pfizer COVID-19 vaccine and at some point during the week after had a seizu...
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Patient recieved dose of pfizer COVID-19 vaccine and at some point during the week after had a seizure that lasted 10 seconds. Patient is being monitored.
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| 66 | 2021-01-21 | weakness | Severe weakness Extreme fatigue Loss of appetite |
| 66 | 2021-01-22 | pain in extremity |
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p...
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Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
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| 66 | 2021-01-22 | burning sensation | burning and itching on neck, began less than 1 day of COVID vaccination |
| 66 | 2021-01-23 | pain in extremity |
Severe pain from shoulder down entire arm to fingers and palm of hand. Lasted for about 32 hours. I...
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Severe pain from shoulder down entire arm to fingers and palm of hand. Lasted for about 32 hours. I felt like my rift arm was paralyzed. I had to sleep with heating pad for relief. Tylenol for pain.
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| 66 | 2021-01-23 | burning sensation |
Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensat...
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Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensation on 1/20/2021 follow by rash in next 24hrs. Confirmed by Doctor on 1/22. Started Valtrex 1/22.
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| 66 | 2021-01-24 | flushing, tingling, feeling hot |
A 66 YEAR OLD FEMALE RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE ON 01/23/21 AND EXPERIENCED WHAT...
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A 66 YEAR OLD FEMALE RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE ON 01/23/21 AND EXPERIENCED WHAT SHE THOUGHT TO BE A REACTION TO THE VACCINE. THESE REACTIONS HAPPENED 3 MINUTES AFTER RECEIVING THE VACCINE. SHE REPORTED FEELING HOT, HAD TINGLING SENSATION AND WAS FLUSHING. REPORTED SHE HAD RED EARS, FACE, AND NECK AND FELT THE FLUSH ALL OVER HER BODY. PATIENT REPORTED THAT SHE TOOK BENADRYL 25 MG PRIOR TO RECEIVING THE VACCINE. SHE ALSO REPORTED THAT SHE TOOK ANOTHER BENADRYL 25 MG WHEN SYMPTOMS SHOWED UP. EMS PERSONNEL OFFERED TO TRANSFER HER TO THE ER BUT SHE STATED SHE REFUSED THIS AND SHE SIGNED AN AMA FORM. PATIENT ALSO REPORTED THAT THE SIGNS AND SYMPTOMS DIDN'T PROGRESS AND SHE BELIEVED THIS WAS DUE TO THE EFFECT OF BENADRY. PATIENT REPORTED THAT SHE STAYED ON THE VACCINATION SITE UNDER OBSERVATION FOR 45 MINUTES AND BY THE TIME SHE LEFT THE SITE, THE SIGNS AND SYMPTOMS WERE GONE. PATIENT STATED SHE WILL CONTACT HER NEW PCP FOR FURTHER ADVISE WHETHER OR NOT SHE CAN GET THE SECOND PFIZER VACCINE. PATIENT DENIES ANY PROBLEM TODAY 01/25/21. WILL CONTINUE TO MONITOR.
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| 66 | 2021-01-25 | tremor | Fever, body ache, HA, nausea, chills, tremors, O2 sat = 96% |
| 66 | 2021-01-25 | pain in extremity |
I had soreness in my arm for two days. I had onset on pain on the 28th, it was sudden and serve. I w...
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I had soreness in my arm for two days. I had onset on pain on the 28th, it was sudden and serve. I went to ER, nausea, vomiting's, diarrhea. They ran a bunch on test and everything came back negative. I had serve abdominal pain, I didn't have any treatment. On 1/2/21 I started antibiotics and was on them until 1/24/21. I'm still not sure if the pain had anything to do with the Covid vaccine.
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| 66 | 2021-01-25 | pain in extremity |
Left arm was sore just a little bit; This is a spontaneous report from a contactable consumer (patie...
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Left arm was sore just a little bit; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 15:15 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient took no other medications in two weeks. The patient experienced that left arm was sore just a little bit on 09Jan2021 . No treatment was received for the adverse events. Clinical outcome of the event was unknown.
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| 66 | 2021-01-25 | flushing |
Patient with known allergies in observation area following injection noted flushed cheeks, chest tig...
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Patient with known allergies in observation area following injection noted flushed cheeks, chest tightness, and reported to clinical manager.(10:16) Given 25mg PO Benadryl and continued observation. AT 10:30, no resolution of symptoms-telehealth visit initiated. Vital signs stable, Oxygen sat at 97%, patient with c/o cough and scratchy throat. Order given and medication administered. Solumedrol 125mg IM. Additional 1 hour observation-symptoms resolved, and patient was discharged to home.
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| 66 | 2021-01-25 | unresponsive to stimuli |
RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHI...
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RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.
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| 66 | 2021-01-25 | pain in extremity |
arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable c...
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arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 11Jan2021 at single dose (1.8 cc but unsure ((heard that but could be wrong) recommended dose)) as works with COVID positive patients. Medical history was none. No concomitant medications. Caller just wanted to know if she could take Tylenol for mild symptoms after having the COVID 19 vaccine. She received the vaccine yesterday. She was wondering if it would make the symptoms a little less. She didn't have a prescribing doctor. The side effects started last night. On 11Jan2021, she was expecting arm soreness, but this was worse. She developed it about 6 hours after the shot. This was the sorest her arm has ever been from any injection, and she had had a lot of them. Her arm was almost too sore to move. This morning, it was much better. It was really bad last night. She was also very achy, and experienced drowsiness, also has a very bad headache on 11Jan2021. The CDC website stated before the vaccine patients should not take Tylenol because it can tamper with the immune system response. It said it was alright to take after, but she just wanted to call to make sure. Investigation Assessment was no. The outcome of the event very achy was not recovered, of the events was recovering.
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| 66 | 2021-01-26 | feeling hot |
PATIENT REPORTED IMMEDIATE TOE TO NECK "IVP DYE TYPE WAVE OF WARM" RESOLVED IN FIRST 5 MINUTES OF OB...
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PATIENT REPORTED IMMEDIATE TOE TO NECK "IVP DYE TYPE WAVE OF WARM" RESOLVED IN FIRST 5 MINUTES OF OBS. HYDRATE FULLY RESOLVED AT DISCHARGE.
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| 66 | 2021-01-26 | pain in extremity, tremor |
Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A hea...
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Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 66 | 2021-01-27 | numbness |
I received the COVID vaccine 1 at 2 PM. At 5:40 PM, the left side of my face was numb. I emailed m...
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I received the COVID vaccine 1 at 2 PM. At 5:40 PM, the left side of my face was numb. I emailed my PCP as to what I should do. She told me to go to Urgent Care as soon as I left work, which I did. Because I had Bell's Palsy two years ago at this time, I panicked. I was told by the Urgent Care doctor that numbness is a common side effect (which I had not previously read like I did Bell's Palsy) and the numbness would subside in about a week. She told me to complete this report.
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| 66 | 2021-01-27 | pain in extremity |
Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report re...
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Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 04Jan2021 15:45, at single dose, for COVID-19 immunization, in her workplace. Medical history included ongoing arthritis (has been cold there) and Crohn's disease so the patient has a tendency to have inflammation. Concomitant medication included vedolizumab (ENTYVIO). The patient experienced joint pain and had a little bit of pain in her finger on the left hand on an unspecified date in Jan2021. Treatment included Salonpas and Tylenol. The outcome of joint pain was recovering (reported as ongoing but a little better); and "has a little bit of pain in her finger on the left hand" was unknown. Information on the batch/lot number has been requested.
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| 66 | 2021-01-28 | difficulty speaking |
24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-remi...
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24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-reminded if She gets worse-GO the ER-or have someone drive her there-for instance-SOB 25th Jan 2021-Monday-legs, to mid calves-swollen 26th Jan Tuesday-still coughing a lot 27th Jan like the 24th of Jan 2021-hurts to breathe, HA, body slows, hoarse when speaking, Cough a lot. 28th Jan 2021-Thursday-her Back hurt. Her waist & shoulder blades painful 29th Jan 2021-today-she said COVID-19 reaction-that's why she called
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| 66 | 2021-01-29 | feeling cold |
24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While...
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24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While trying to get blankets, turning up heat, preparing dinner, had abnormal muscle and joint pain upon any movement. No muscle or joint pain while sitting still.. 6 hours after symptoms took acetaminophen 500mg and diphenhydramine 25mg . 9 hrs after onset of symptoms felt fine with no symptoms and slept through the night fine. 48 hrs after vaccine feel completely normal.
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| 66 | 2021-01-29 | weakness | Extreme fatigue, unable to stand or walk, dizziness, physical weakness, upset stomach, |
| 66 | 2021-01-29 | tingling, numbness |
Numbness,tingling sensation-I left-side-of-face.??Started-35-hours-after-injection. Lasted3-4hours.-...
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Numbness,tingling sensation-I left-side-of-face.??Started-35-hours-after-injection. Lasted3-4hours.-no-other-neurological-symptoms- Took-aspirin-as-symptoms-subsided.
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| 66 | 2021-01-29 | pain in extremity |
The night of the shot I got very little sleep due to my entire right arm which took the shot aching ...
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The night of the shot I got very little sleep due to my entire right arm which took the shot aching and hurting all night til I got up the next morning. Have had not other symptoms but it did scare me that night. My husband experienced soreness of the arm and fatigue.
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| 66 | 2021-01-30 | pain in extremity, weakness |
This was my second dose of the Pfizer vaccine. First day I felt soreness on my left arm where shot...
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This was my second dose of the Pfizer vaccine. First day I felt soreness on my left arm where shot was administered and I had stomach cramps through the day. Had to eat very light. Woke up with an intense headache during the night, which continued all through Saturday 1/30/2021 and into the night. I started with a fever of 100.5 and it climbed to approximately 102 in late afternoon on Saturday. Saturday afternoon got nauseous and remained that way through the night. Most symptoms have stopped on Sunday morning, although my stomach is very unstable and I feel weak. I took Tylenol through the day and at midnight on Saturday at recommended doses or less. Temperature 99.1 on Sunday afternoon and haven?t taken a Tylenol since Saturday night.
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| 66 | 2021-01-31 | tingling, numbness |
Facial muscle tingling which quickly turned to numbness occurred at 5 Pm 1/29/21 Tingling started i...
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Facial muscle tingling which quickly turned to numbness occurred at 5 Pm 1/29/21 Tingling started in lips and then moved up the left side of face to forehead and including part of left ear. Numbness followed Symptoms lasted about 3 hours.
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| 66 | 2021-01-31 | feeling hot, tingling |
Pt. Reports ?warm tingle? in chest, back of neck, L arm. V/S 120/80-BP, 88-HR, 98%-O2, 20-resp. Pt. ...
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Pt. Reports ?warm tingle? in chest, back of neck, L arm. V/S 120/80-BP, 88-HR, 98%-O2, 20-resp. Pt. Reports to ?feeling a little anxious? about receiving vaccine. At 10 minutes pt. Reports wariness/tingle was gone. ~20 minutes pt. Reports feeling is now back in opposite are and again in next. V/S 125/80-BP, 85-HR, 98%-O2, 18-resp. ~25 minutes pt. Reports symptoms are again gone. Pt. Education if symptoms return/worsen to seek medical attention. Pt. Expressed understanding.
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| 66 | 2021-01-31 | muscle twitching, numbness |
Second vaccine Lot Number - EL3248 . 1/19/2021. Twitches in the left calf on the back. Then went t...
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Second vaccine Lot Number - EL3248 . 1/19/2021. Twitches in the left calf on the back. Then went to the upper leg. Short pains then they would come and go. Then the pain went to the right leg. Numbness under the left knee. Feel like her calf is full. Going to see a neurologist.
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| 66 | 2021-01-31 | pain in extremity |
itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an ...
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itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; arm soreness; dry throat; arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 17Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included Cholesterol and Blood pressure, patient stated she took low dose medication for her blood cholesterol and blood pressure, but has had no new medications. She had a history of some allergies: a slight shrimp and scallops allergy, possible peanuts, penicillin, and a Neomycin product. She said they were not a big deal, and she had environmental allergies as well. She had an allergic reaction to the eye drop Neomycin, possibly, just the eye drop, she had a little breakout around her lips but she didn't know if it was the drug or not. The allergy to shrimp and scallops showed up in a blood test, her reaction to peanuts around her mouth but she had a negative scratch test and blood test for allergy to peanuts. The patient's concomitant medications were not reported. The patient stated she did get the flu vaccine, that was ok, she was fine, this was probably around Nov2020 or so, though she didn't know off hand when she got it, it was the regular flu vaccine and not an increased dose. The patient experienced arm discomfort on 17Jan2021, itching to eyes, mouth, and throat an hour after vaccination on 17Jan2021 12:00. The patient took the first shot yesterday (17Jan2021) and she had some discomfort to her arm, but it didn't bother her. She got the shot about 11:00 yesterday (17Jan2021) and about an hour after the shot she had some itching to her eyes, mouth, and throat that was not severe then was on and off through the day. She would like to know if this is common, she would like the information for the second dose, if she should expect more or less or same, she was concerned about the second dose. She did not have a severe reaction, she just wanted to make sure there weren't any adverse reaction for that make sure she known. She had not seen a doctor for her itching eyes, mouth, and throat. She didn't do any treatment for it, it was better today (18Jan2021), she just noticed it an hour after the injection that she felt a bit of eyes being itchy and all over, her mouth and throat were not severe, but she definitely felt it through the day. She felt it a little at night sometimes anyway like a dry throat. It was gone this morning and her arm was better, it seemed like the itching went with the arm things since following her arm soreness her itchiness started, then when her arm felt better the itchy was going away. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
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| 66 | 2021-02-01 | feeling hot |
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetic, allergies, asthma and allergies to mold, pollen and iodine. Concomitant medications included metformin, glimepiride, simvastatin, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and amitriptyline. The patient previously took cefaclor (CECLOR) and experienced allergies. On 15Jan2021 at 15:15, the patient's face, chin and chest turned bright red. The patient also experienced hot sensation all over and tightness when breathing. No treatment was received. The outcome of the events was recovered on an unspecified date. Information on Lot/Batch number has been requested.
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| 66 | 2021-02-01 | pain in extremity |
extreme tiredness, Malaise with body and joint aches, asthma minor flare up, wheezing that woke me u...
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extreme tiredness, Malaise with body and joint aches, asthma minor flare up, wheezing that woke me up during the night. Sore L upper arm
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| 66 | 2021-02-01 | pain in extremity, breast pain |
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne...
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pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
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| 66 | 2021-02-01 | pain in extremity |
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going...
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soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization. Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine. The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours. Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious. Information on lot number/batch number was requested. Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
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| 66 | 2021-02-02 | pain in extremity |
I work up at 2am with my right pinky- first knuckle - pounding in pain. Never had that happen befor...
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I work up at 2am with my right pinky- first knuckle - pounding in pain. Never had that happen before. Then I realized my mouth was extremely dry. I got up, drank some water and layed back down. After about 15-20 minutes the pain subsidded and I was able to fall back to sleep. Just weird! Odd side effect for sure. Hope the second shot is that simple too!
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| 66 | 2021-02-02 | pain in extremity |
Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. A...
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Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. All was okay, until I got in the car to drive home. My tongue began to tingle and headaches began. I immediately took an antihistamine as a tingly tongue for me is a sign of an allergic reaction. I then had a band like pain across my upper back, and then the chills, tiredness, nausea, sore throat, sore arm which are all normal reactions from the printed information - well except for the tingly tongue and a red rash across my nose, cheeks and chin. Tingling and rash subsided about an hour after taking the antihistamine, but all of the other symptoms remained. My shot was at 1:50 PM and just before 11 PM I had instant onset of pain in my chest wall with breathing. It went across the top of both breasts in the center where my ribs meet my sternum. This has lessoned with laying down, but when I am up and about it increases although not as bad as last night. I am also experiencing bursts of itchy spots all over. As I have an EpiPen I did not go to hospital but am wondering about what to do for the 2nd shot. I think it will be best if I take an antihistamine prior to the shot and I will continue taking them for this one until my symptoms go away.
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| 66 | 2021-02-02 | numbness | tightness in chest, numbness in legs and feet |
| 66 | 2021-02-03 | numbness, tingling |
Approximately 6 hours after injection, I began feeling very tired. I was up walking around office w...
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Approximately 6 hours after injection, I began feeling very tired. I was up walking around office working on some computer updates and then cam back to my office. About 15 minutes later while sitting at my desk my hand and feet began tingling, then about 10 minutes later my feet became numb, from toes to ankle, both ankles began to swell and had +Edema, and blood pressure was 123/50 , pulse low and undetected on my electronic BP cuff, taken by wrist it was 42, event lasted about 30 minutes, I forces fluids, took a Benedryl, and walked in my office when numbness subsided.
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| 66 | 2021-02-03 | pain in extremity |
Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to ...
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Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to sleep. Headache resolved the next morning. Sore arm resolved in about 2 days
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| 66 | 2021-02-03 | pain in extremity |
Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in he...
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Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
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| 66 | 2021-02-03 | numbness, inability to speak, weakness |
Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood P...
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Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood Pressure Emergency Room High. Fast heartbeat. Dizziness. Weakness. Trouble communicating-at a loss for words. Took Lisinopril-HCTZ20-12.5 while being monitored by RNs for BP and heart rate. 5 minutes thereafter, fuzzy cloud lifted from brain. Eventually felt OK to leave site.
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| 66 | 2021-02-03 | discomfort |
Patient complained of pressure/swelling of left axilla and left side of neck. BP 112/60 (repeat, 110...
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Patient complained of pressure/swelling of left axilla and left side of neck. BP 112/60 (repeat, 110/69), pulse 73 (repeat 72), and O2 sat 96% to 97%. Drank apple juice and water - felt well enough 40 minutes later to leave for home.
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| 66 | 2021-02-03 | feeling hot |
tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensat...
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tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensation and sore throat
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| 66 | 2021-02-04 | numbness |
facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolv...
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facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
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| 66 | 2021-02-04 | pain in extremity |
her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has r...
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her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has really bad arthritis like she has had a knee replacement/her arthritis is really bad/it just flared up; She had a little pain in her leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (Pfizer BioNTech COVID 19 vaccine, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration on 12Jan2021 09:30 at single dose in Left upper arm for covid-19 immunization. Vaccination Facility Type was at a hospital, they had a vaccine clinic set up. Vaccine Administered at Facility was No. Medical history included arthritis, she has had a knee replacement, she was allergic to anti-inflammatory medicines. Family history was none. There were no concomitant medications. No other vaccines was administered on same date of the bnt162b2. Prior Vaccinations (within 4 weeks) was None. No events occurred following prior vaccinations. Patient was calling about a question with the COVID-19 vaccine. She got it on Tuesday 12Jan2021 and she wanted to know if she could get a reaction now. Yesterday (20Jan2021) she noticed, she had really bad arthritis like she has had a knee replacement and she has it her hands and yesterday she noticed her wrist was swollen and she didn't know if it could have been where she had arthritis or could it be side effect? She just didn't know if she should call her orthopedic doctor. She said the joint at the wrist, it was like the side of her hand, it was the side where your pinky was, just above the bone on her wrist it was swollen. It was swollen normally but it usually didn't hurt like this, it was like a burning but it maybe her arthritis acting up but she did not know. She said the pain and swelling began yesterday 20Jan2021. Her wrist was swollen and it was like a burning was reported as worsened. She had a little pain in her leg the other day on 17Jan2021 but just coughed it up. It was all on the left side which was the same side she got the injection on. She didn't think anything of the leg pain and it went away. The pain in her leg has resolved completely. The only other thing was her arthritis was really bad, it just seemed that it just flared up but she was wondering if it could be a side effect. The events didn't require a visit to emergency room or physician office. The outcome of "She had a little pain in her leg" was recovered in Jan2021, while outcome of other events was unknown.
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| 66 | 2021-02-05 | pain in extremity |
I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my hea...
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I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my heart rate doubled. It took around an hour for my heart rate to slow down again. By bedtime all I had was a sore arm. That was gone within 24 hours.
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| 66 | 2021-02-05 | migraine | Mild to Severe migraine still have it. Chills and stiff neck. |
| 66 | 2021-02-06 | pain in extremity |
9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch...
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9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch. Arm again moderate sore. Same reaction after initial shot which cleared up around 5th day. No other symptoms.
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| 66 | 2021-02-06 | weakness | Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea |
| 66 | 2021-02-07 | weakness |
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Bena...
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1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
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| 66 | 2021-02-07 | seizure |
24 hours after second Pfizer dose, multiple Seizure activity occurred. Client was transported to the...
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24 hours after second Pfizer dose, multiple Seizure activity occurred. Client was transported to the hospital for a 3 day stay. During that visit client was sedated and has little recall of hospitalization. Medication upon discharge - Keppra 750mg BID. First dose Pfizer 1/12/21 no reaction, not even sore arm
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| 66 | 2021-02-07 | facial pain |
About 24 hours after the 2nd dose, I had extreme nerve sensitivity on the left side of the face. Thi...
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About 24 hours after the 2nd dose, I had extreme nerve sensitivity on the left side of the face. This pain and sensitivity to touch went from my forehead above the eyebrow down to my chin. It included my left eye. It also seemed to affect my throat. The left gland popped and the left side of my throat was very sore. This issue responded somewhat to Advil but never fully went away and only dissipated for about an hour in between Advil doses. It lasted about 30 hours. I hadn't read or heard anything about a reaction like this so wanted to provide the information.
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| 66 | 2021-02-07 | numbness, tingling |
Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbnes...
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Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbness and tingling in her hand. This progressed to right leg numbness, tingling and weakness and right lower face tingling. Patient denied any facial droop, slurred speech, confusion or dizziness. Patient reports that symptoms peaked the night of the vaccine around 9 or 10pm and had gotten better but not totally resolved. She was advised to go to the ER and was admitted. MRI showed an acute infarct in the left basal ganglia. CTA showed "short segment moderately severe narrowing of the M1 segment of the right MCA." Neurologist was consulted and determined it to be coincidental that the patient had her COVID vaccine the same day.
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| 66 | 2021-02-07 | weakness | Felt weak |
| 66 | 2021-02-07 | tremor, night sweats | vomit once shakes |
| 66 | 2021-02-08 | pain in extremity |
I experienced a very sore arm, which was swollen and painful to touch. In addition, I felt some let...
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I experienced a very sore arm, which was swollen and painful to touch. In addition, I felt some lethargy. These symptoms lasted 36 hours.
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| 66 | 2021-02-08 | discomfort |
Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement...
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Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement, continues to work, does not interfere with ADLS. Recommend to follow-up primary care doctor.
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| 66 | 2021-02-08 | tingling |
left eye pain and redness, red patches and swelling under left eye started out slight and has swolle...
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left eye pain and redness, red patches and swelling under left eye started out slight and has swollen bag under eye, itchy eyes, redness and tingling in the area has also moved to my upper eyelid and eyebrow/temple area. Left cheek and left side of head are tingling.
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| 66 | 2021-02-09 | weakness |
Client alerted onsite EMS concerning weakness. VS: B/P 130/60, Heart rate 72. Client stated she felt...
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Client alerted onsite EMS concerning weakness. VS: B/P 130/60, Heart rate 72. Client stated she felt better and asked her husband to drive. Client released home at 8:28 am.
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| 66 | 2021-02-09 | cold extremities |
Did the adverse event start after the first or second vaccination? both Date and time of vaccinatio...
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Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 1-6-2021 @ approx 10:15am Pfizer LOT # EL3246 1-27-2021 @ approx 11AM Pfizer LOT # EL9262 Date and time adverse event started: 1-31-2021 at approx 8:30am, cold hands/feet, nausea, HA, pain to bilateral eye, mid lower back aches radiating to upper. today 2-5-2021 losing voice, all symptoms are reported to be intermittent Pfizer LOT # EL3246
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| 66 | 2021-02-09 | flushing |
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2...
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Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
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| 66 | 2021-02-09 | pain in extremity |
Rash more like itchy area above the injection site; Rash more like itchy area above the injection si...
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Rash more like itchy area above the injection site; Rash more like itchy area above the injection site; Sore arm; reconstitution problem / 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS; patient received approximately "double strength dose"/ 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS, the recommended 0.3ml dose was then administered to the patient; medical history included rheumatoid arthritis; medical history included rheumatoid arthritis; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, exp. date May2021) via unspecified route of administration on 25Jan2021 at 11:45am at 0.3 mL single dose in right deltoid for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications included ongoing hydroxychloroquine for rheumatoid arthritis. The patient experienced sore arm on 26Jan2021, rash more like itchy area above the injection site on 27Jan2021. The patient had no treatment. Pharmacist stated is was a reconstitution problem. He did not have a syringe bigger than 1 ml so he put 0.8 ml, got distracted and forgot to put the rest of the diluent. 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS. The recommended 0.3ml dose was then administered to the patient. The patient received approximately "double strength dose". After applying the vaccine, he remembered that he did finish the preparation of the vaccine. The patient is a co-worker and they have been checking on her to see if she developed any adverse effect. The event was reported as non-serious. The patient recovered from sore arm. The patient was covering from rash more like itchy area above the injection site.
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| 66 | 2021-02-09 | numbness, tingling |
This is a 66-year-old female past history of asthma, COPD, carotid stenosis who presents with a COVI...
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This is a 66-year-old female past history of asthma, COPD, carotid stenosis who presents with a COVID-19 vaccine side effect. Patient states she got her second Covid vaccine this morning and shortly thereafter noticed numbness in her left arm. She states that the numbness is directly in line with the injection location. She states it has not improved nor worsened over the course of the day. She still has strength in her left upper extremity. She states that within the first hour or 2 after injection and she noted some perioral numbness. She states that her lips were tingling and then she noted on her cheeks and then down the sides of her neck. She states she never had any difficulty swallowing or difficulty breathing. She states that she became concerned because this is very atypical for her as she has never had paresthesias in these locations. Patient states that she was encouraged by her doctor to come to the emergency department. Over the past 10 hours that she has been in the waiting room her facial symptoms have improved. She states that her lips only now feel like she is "coming back from Novocain ". She states that she no longer has the facial paresthesias no other paresthesias in her neck. She states that the paresthesias in her arm are unchanged. She denies any fever, chills, nausea, vomiting, dizziness, urticaria, facial swelling, oral swelling, pharyngeal swelling. Facial paresthesias are bilateral and without droop of the face.
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| 66 | 2021-02-09 | pain in extremity |
bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle; there was ...
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bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle; there was soreness; bleeding from where the nurse injected her; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration injected into right arm on 24Jan2021 at 05:45PM or 05:44PM at single dose for COVID-19 vaccination. Medical history included Graves' disease, she was diagnosed in the 1980s with Graves' disease, which became Hashimoto's so she took Synthroid, because she believes it switched from hyperthyroid to hypothyroid, and Lichen sclerosus. Concomitant medication included levothyroxine sodium (SYNTHROID) for Graves' disease and Hashimoto's, furosemide, and fluocinolone acetonide for Lichen sclerosus. On 24Jan2021, the patient experienced bump in the arm, She said that the bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle, at its largest it was bigger than a half dollar, now it's a quarter. She said that they did no treatment, there was soreness, but it has not required treatment, the discomfort was bearable. She said after she was given her shot she was bleeding nurse from where the nurse injected her, she sometimes did that, it was not related at all, blood dripped down her arm, she had to wipe her arm. The outcome of the events was unknown. She said she would like to know if Pfizer had info information about whether she should have her supplements, like Vitamin B, C, D and her Furosemide, and whether she could have Zinc or Magnesium as well. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the information available a possible contribution of the vaccination with BNT162B2 towards the onset of vaccination site bleeding cannot be fully excluded.
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| 66 | 2021-02-09 | pain in extremity |
chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable cons...
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chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable consumer reported for herself. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREL1283), via an unspecified route of administration on left arm on 13Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included diabetic, highwood pressure, kidney issues. The patient's concomitant medications were not reported. The patient previously took hydrocodone, morphine, oxycontin, metformin, trulicity, all experienced drug allergy. The patient experienced chills, fatigue, headache, soreness in her arm, all on 13Jan2021 16:00 with outcome of recovered on 14Jan2021 16:00. This last for about 24 hrs. No treatment received for these events.
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| 66 | 2021-02-10 | tremor | Fever 103 Body aches Uncontrollable shaking and chills Headache Nausea |
| 66 | 2021-02-10 | weakness |
Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwel...
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Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwell, weakness, brain fog, lasted 40 hours.
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| 66 | 2021-02-10 | tingling |
Patient stated she started feeling tingling on her forehead and seconds after it went away but she s...
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Patient stated she started feeling tingling on her forehead and seconds after it went away but she started to feel numbness on the top of her mouth. No allergies reported. No medications were administered, patient stated she is feeling better 15 minutes after. Patient refused to go to the hospital, she said she is doing better and wants to go home.
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| 66 | 2021-02-10 | breast pain |
on the fourth day following the second dose A red area painful appeared on my right breast with a lu...
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on the fourth day following the second dose A red area painful appeared on my right breast with a lump about size of cashew nut just above nipple area. It is still there on 6th day although not as sore. I have not received treatment or gone to doctor, waiting to see if it goes away in a few days.
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| 66 | 2021-02-11 | flushing | Flushed |
| 66 | 2021-02-14 | muscle spasms |
No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the foll...
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No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the following reactions, which lasted about 12 hours. Projectile vomiting and dry heaves Nausea Muscle aches, cramps, and spasms Chills Fever Sweats Headache in upper shoulders, neck, and back of head (intense)
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| 66 | 2021-02-14 | pain in extremity |
Very sore arm later the day of shot and worse the next day Sudden onset of horrible headache and chi...
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Very sore arm later the day of shot and worse the next day Sudden onset of horrible headache and chills 2/14/2021, 6 AM Still experiencing headache and some chills 2/15/2021
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| 66 | 2021-02-14 | tremor |
Woke up shaking, headache, hurting all over. Lasted about an hour. Feeling tired still on day 6. ...
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Woke up shaking, headache, hurting all over. Lasted about an hour. Feeling tired still on day 6. Day 4 one cold sore started, Day 5, two more cold sores.
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| 66 | 2021-02-15 | tingling |
After client received vaccine client stated she had tingling in left arm. Vital signs obtained by E...
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After client received vaccine client stated she had tingling in left arm. Vital signs obtained by EMS: BP 164/100, repeat 155/87, Pulse 90, O2 sat 98%; Client stated she feels better. Client discharged home by EMS.
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| 66 | 2021-02-15 | weakness |
Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tire...
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Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tired and sleepy. Nausea, weak, headache, feeling unwell. Took a valium to calm down. Felt better around 10 pm on 2/14 but lasted through 2/15. Woke up on 2/16 with my bed soaking wet.
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| 66 | 2021-02-15 | weakness, cold sweat, pain in extremity |
Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I starte...
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Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I started feeling bad. I felt tired, real weak, sleeping, wanting to sleep, fever, headache, pressure on my head, sweating, calmly feeling, cold sweats. As of today I started to feel a little better but I still have a grade fever. I have been taking Tylenol for it.
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| 66 | 2021-02-15 | pain in extremity |
She received 1st dose of COVID vaccine on Jan 26, 2021. She waited 15 minutes without any reaction a...
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She received 1st dose of COVID vaccine on Jan 26, 2021. She waited 15 minutes without any reaction at the facility. On ride home, approximately 30-45 min after getting the dose, she noticed her tongue was visibly swollen. No swelling of lips, hive, difficulty breathing, noticeable swelling of throat, lightheadedness, fever, or diarrhea. It subsided after 30 minutes. She did not seek medical attention or have a clinical evaluation. She had soreness in her arm for 3 days but otherwise had no ongoing symptoms.
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| 66 | 2021-02-15 | numbness, burning sensation, feeling jittery, hot flush, pain in extremity |
pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of fa...
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pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of face persists.
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| 66 | 2021-02-15 | feeling hot, depressed level of consciousness, tremor |
patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. pat...
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patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. patient wheeled to vaccine waiting room. patient became lethargic and blacked out. patient not alert and awake for approximately 1 minute. patient came to, pulse 80, blood pressure 93/70, oxygen saturation 98%, husband at side, emergency cart and AED and oxygen brought to location of the patient. oxygen 2L nasal canula placed on patient. EMS called and Dr. came to site. assessment obtained with Dr. at site. patient awake, was able to speak full name but stated she was not aware of where she was. this reaction happened approximately 6 minutes post immunization. within approximately 3 minutes of episode where she states she felt she was going to "black out" she began to shake/ full body involvement. during this episode patient was following nurse commands. momements were rhythmic and lasted approximately 10 seconds then stopped. Patient brought back to exam room. at 138pm- temp 97.5, blood pressure 144/31, pulse 51, respiration 18. patient stated she felt warm and reports she felt she was going to black out. this episode lasted approximately 3 seconds and patient became alert at that time. vitals at 140 pm- blood pressure 124/60, pulse 75, respirations 16. vitals at 144pm- blood pressure 119/75, pulse 75, respirations 16. patient has dialysis 4 times a week for CKD stage 5. patient has lengthy medical history. patient reports her primary care doctor is Dr. who sees her frequently. patient reports she has an issue with internal bleeding with source unknown and at times has to have blood transfusions. no recent illnesses reported. patient states she ate breakfast around 10am today. patient states she has never had a vaccine reaction int he past or reaction to needles. EMS arrived on site approximately 1345. report given to EMS. patient alert with EMT. patient transferred from her personal wheelchair to EMS cot. patients husband left with patient to go to Medical Center. Patient tolerated vaccine well immediately after immunization. She reported no pain at injection site. Paper tape and 2x2 gauze placed at injection site due to allergy to tape. Allergy list was reviewed prior to administration of vaccine. Patient alert and oriented prior to vaccine to person place and time. Husband present in room. Verbal consent obtained by patient to receive covid vaccine today . Vaccine information handout and emergency use handout given to patient. Patient wheeled out of exam in wheelchair.
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| 66 | 2021-02-16 | pain in extremity |
Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days ...
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Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days Upper arm still sore after 12 days. Pain on movement and unable to sleep on that side, as the arm pain awakens me. Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
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| 66 | 2021-02-16 | feeling hot, flushing |
Patient began to feel flushed, hot. No nausea or vomiting. No shortness of breath or light headed ...
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Patient began to feel flushed, hot. No nausea or vomiting. No shortness of breath or light headed ness. O2 sat 100%, resp 18, BP 140/76, heart rate 67. Symptoms resolved and patient discharged from clinic
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| 66 | 2021-02-17 | feeling hot |
Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest...
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Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-02-18 | pain in extremity |
2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F...
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2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F maximum 2/13/21: swollen lymph glands in neck, slight sore throat, afebrile, generalized rash over trunk and anticubital area 2/14/21: swollen lymph glands in neck, slight sore throat, afebrile, rash mostly faded 2/15/21 to 2/18/21 swollen glands in neck, slight sore throat, afebrile, no rash 2/19/21 (today): swollen lymph glands in neck, slight sore throat (improving), afebrile, no rash
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| 66 | 2021-02-18 | feeling cold |
2/13/21 -- c/o fatigue; slept most of the day, cold; warmed with blankets 2/14/21 -- chilled, can't ...
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2/13/21 -- c/o fatigue; slept most of the day, cold; warmed with blankets 2/14/21 -- chilled, can't warm with blankets; no thermometer available 2/15/21 -- somewhat tired, better 2/16/21 -- visited ED for lymphedema treatment (chronic idiopathic condition) of ankles and mid-calf; treated with prednisone
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| 66 | 2021-02-18 | pain in extremity, nerve pain |
Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side...
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Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side of neck, back left shoulder, radiating down left arm. Constant pain - much worse during sleep. Unable to sleep, changing positions little help - better sitting up or in high recline in bed. Treating with Tylenol, Ibupropfen periodically. Applying cold compress and warm compresses alternatively. Tried analgesic cream rub with little success. Able to exercise with little change. Rubbing of neck muscles helps somewhat.
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| 66 | 2021-02-18 | hot flush |
Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereaft...
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Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereafter for about an hour. Heavy fatigue all afternoon into the evening Extreme muscle fatigue 2 and 3 days afterwards in my legs making it feel like a statin reaction hard to walk with a normal stride.
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| 66 | 2021-02-18 | flushing | Flushing, dizziness, nausea, headache, weird taste in the mouth. muscle ache. |
| 66 | 2021-02-18 | pain in extremity, discomfort |
The morning after receiving the vaccine in my left arm, I woke up with more than moderate pain in my...
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The morning after receiving the vaccine in my left arm, I woke up with more than moderate pain in my left hand when I tried to grip something, make a fist, or spread my fingers. I had no other symptoms besides a mildly sore arm - expected. Almost a week later, my arm is 100% (it was after a day or 2), but I still have pain in my hand. Had no pain at the time of the injection - barely felt it, so I don't think the needle hit a nerve. Could the vaccine substance have irritated the nerve? The pain seems to be focused on the center of my hand. If I press firmly on that spot, I can produce discomfort. My hand does not ache or hurt if it's at rest. The discomfort does not prevent me from carrying out the normal activities of life. Just thought I should report it. That said, happy for any thoughts about how to make it go away! Many thanks. Very grateful to be vaccinated.
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| 66 | 2021-02-18 | pain in extremity |
dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issue...
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dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020. Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization. On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around. On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
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| 66 | 2021-02-19 | numbness | 30 hits after vaccine , i developed numbness throughout left side of my face. |
| 66 | 2021-02-21 | night sweats, pain in extremity |
Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue...
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Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue, really sore arm. Night sweats. Lasted about 48 hours. I'm still waking up with a pounding headache every morning. Still lingering sense of unwellness.
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| 66 | 2021-02-21 | pain in extremity, breast pain, tingling |
Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm ...
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Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm and hand as well.
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| 66 | 2021-02-21 | unresponsive to stimuli |
Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately...
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Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately, patient still with BP WNL, oxygenating fine, had a pulse. gag reflex+ when oral airway placed. Taken to ED w/ team. Epi IM given, Ativan given, Benadryl given, glucose given. Pt became awake and alert, talking, observed at ED, then discharged to home at 1226
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| 66 | 2021-02-22 | pain in extremity |
2 days after vaccination right thighs and right leg started to have pain similar to pain I got with ...
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2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple thousand miles last year and no issues.
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| 66 | 2021-02-22 | pain in extremity |
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ...
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About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
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| 66 | 2021-02-22 | feeling cold | Chills, feeling cold |
| 66 | 2021-02-22 | numbness | Facial numbness left side only |
| 66 | 2021-02-22 | weakness |
Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day ha...
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Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days
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| 66 | 2021-02-23 | pain in extremity |
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha...
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The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
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| 66 | 2021-02-23 | night sweats |
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headac...
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Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5. Day 5 Morning - rapid test negative, fever 99.9. Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly. Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine. I am an allergig person whose eosinophils report for duty quickly and obviously too much! I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included. Your call.
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| 66 | 2021-02-23 | muscle spasms |
fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root ...
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fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root canal on day 4 with "dying nerve", butterfly (lupus like) rash on face day 4, "covid arm" day 4 with tennis ball size red knot around injection site that extended down arm over next several days, winded for several days, fatigue and shortness of breath.
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| 66 | 2021-02-24 | flushing | Nausea, flushed, feeling anxious, evaluated by EMS-cleared |
| 66 | 2021-02-24 | flushing |
Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes la...
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Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes later at 1246 she started to feel a flushed face, nasal and sinus congestion and stated that her throat felt as if it was swelling. Benadryl 50 mg orally was administered. VS were checked BP 128/80, HR 82. Pt stated she was feeling improved at 1315 and stated her throat felt much better, denies feeling swelling in her throat. No evidence of mouth, tongue or lip swelling, no evidence of angioedema. No evidence of respiratory distress, no wheezing, speaking in full sentences. No rash. Reassessment @ 1345: One hour after patient received benadryl she stated she felt much improved aside from mild body itching. Requesting to leave with husband. Advised to continue benadryl 50 mg every 6 hours as needed for symptomatic and follow up with her primary care doctor and allergist.
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| 66 | 2021-02-24 | pain in extremity |
Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the sym...
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Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the symptoms. Fatigue (not able to complete the routine daily walk of 3 miles) the day after vaccination for one day.
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| 66 | 2021-02-24 | flushing |
Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing....
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Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing. These symptoms came in waves and is a normal reaction I get with medication I am sensitive to. However because I not having a normal reaction, I was told to go to an emergency room for a EKG. I knew this wasn?t a heart event, but a reaction to the vaccine. It is a normal reaction for me. I?ve dealt with it most of my life.
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| 66 | 2021-02-24 | numbness |
mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a...
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mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 66 years, on 10Feb2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took tetracyclines and experienced drug hypersensitivity, pneumovax vaccin and experienced drug hypersensitivity. On 10Feb2021, the patient experienced numbness of left arm, shoulder and left side of face and some tongue swelling. The patient applied ice for several hours. After 5 hours or so, the face and tongue were back to normal. The following day (11Feb2021), they noticed mouth sores. The patient used salt water rinse to help. The patient asked if she should be avoiding the 2nd dose scheduled in 18 days as a result of this reaction. Therapeutic measures were taken as a result of numbness of left arm, shoulder and left side of face (hypoaesthesia), some tongue swelling. (swollen tongue), mouth sores (stomatitis). The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 66 | 2021-02-25 | flushing |
Client c/o flush feeling 3 minutes after receiving vaccine. Client is seen and assessed by EMS and ...
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Client c/o flush feeling 3 minutes after receiving vaccine. Client is seen and assessed by EMS and VS are B/P 128/86, HR-90, O2 98. Client denies any other symptoms and verbalizes that she no longer was having symptoms and velar by EMS.
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| 66 | 2021-02-25 | tenderness, numbness, hypersensitivity of all senses |
I experienced tenderness, sensitivity to touch, swelling, and numbness (ALL SLIGHT) to the left side...
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I experienced tenderness, sensitivity to touch, swelling, and numbness (ALL SLIGHT) to the left side of my face, including around my eye, jaw, and lips.
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| 66 | 2021-02-25 | seizure like phenomena |
Patient had seizures like symptoms after receving Pzifer Covid vaccine. EMS was called but patient w...
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Patient had seizures like symptoms after receving Pzifer Covid vaccine. EMS was called but patient was not transported. Patient was released to home
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| 66 | 2021-02-25 | flushing |
Patient was given the Pfizer vaccine at a drive through clinic. While waiting for a reaction - about...
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Patient was given the Pfizer vaccine at a drive through clinic. While waiting for a reaction - about 15 to 20 minutes the patient developed a flush feeling and thickness of the tongue. Patient was given an epi pen shot to her left thigh and felt better within minutes. Patient refused to be transported to the hospital for evaluation.
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| 66 | 2021-02-25 | weakness |
headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report...
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headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report from a contactable healthcare professional. This 66-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot EL3247) on 24Jan2021 at 11:15 AM at left arm for COVID-19 immunization in hospital. Historical vaccine included first dose for BNT162B2 (lot EK5730) on 02Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Medical history included hypo thyroid, parox afib, high blood pressure (HBP), obesity and allergies: bupropion hydrochloride (WELLBUTRIN), soy. Concomitant drugs included metoprolol, apixaban (ELIQUIS), fluoxetine hydrochloride (PROZAC), losartan potassium (COZAAR), thyroid (ARMOUR THYROID) and more. On the day of injection on 24Jan2021 at 04:00 PM, the patient had low blood sugar symptoms, weakness, which resolved in a few hours. On second day, symptoms of low Blood sugar, sweats, feverish, chills, on third day feverish symptoms of low blood sugar, sweats, feverish, headache. No treatment was received. The outcome the events was unknown.
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| 66 | 2021-02-26 | pain in extremity | Headache for 5 days. Extremely sore arm for 5 days. Unusual Fatigue 3 days. |
| 66 | 2021-02-26 | pain in extremity | Nausea Achy Chills Headache Sore arm at site Fatigue |
| 66 | 2021-02-26 | feeling cold |
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank...
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Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
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| 66 | 2021-02-27 | discomfort | Chills, progressed to fever of 100 F, muscle aches, swelling and discomfort in left armpit |
| 66 | 2021-02-27 | pain in extremity | Headache Fatigue-minor Sore arm |
| 66 | 2021-02-27 | tingling, numbness |
mild bi-lateral numbness and tingling of hands and FINGERS during morning of 2/11 (3 or 4 on a scale...
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mild bi-lateral numbness and tingling of hands and FINGERS during morning of 2/11 (3 or 4 on a scale of 10); does not interfere with ADL - right side: Becoming interment during the afternoon and disappearing on the right by evening. - Left side: tingle and numbness lasted longer. became intermittent during the evening of 2/11 Day of 2/12: experienced occasional tingling on right and more frequently on left. 2/13: tingling mostly gone However, will still occasionally notice a small bit of residual tingling and numbness 2+ weeks later. low frequency, 1 or 2 on a scale of 10
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| 66 | 2021-02-28 | feeling hot |
Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home ...
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Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home I had the dry heaves. I was also alternating hot and cold. This went from about 7 pm to 8 AM the next day. That day I had a head ache which I normally do not have.
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| 66 | 2021-02-28 | flushing |
Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occ...
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Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occurred immediately after receiving vaccine. Client seen and assessed by EMS an Vital signs are B/P 147/82, HR 80, O2 100%. Pt. voice that her anxiety level increased when receiving vaccine but now has decreased and symptoms decreased during observation. Second round of vitals B/P 139/82, HR 76, O2 99%. Client then verbalized that she is no longer having the sensation and asked to go home after 45 minutes of observation. Client denied the need to go to or be taken to the hospital and was cleared to go home by EMS. No physical reaction noted.
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| 66 | 2021-02-28 | flushing, hot flush |
Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermitte...
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Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermittently then dissipated.
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| 66 | 2021-02-28 | flushing | Flushing at 1130, fatigue during first day, extreme joint and muscle pain second day |
| 66 | 2021-02-28 | muscle spasms |
Headache in the back of my neck radiating up into the back of my head; Headache in the back of my ne...
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Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
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| 66 | 2021-02-28 | weakness |
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room....
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Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
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| 66 | 2021-02-28 | migraine |
The day after my first vaccination at 3:15 PM I started getting visual auras and then migraine whic...
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The day after my first vaccination at 3:15 PM I started getting visual auras and then migraine which lasted about 4 hours. I have had up 7 more since then and after my 2nd vaccine. Dr. thought it might be related since I have no history of chronic migraines. All past were over 16 years ago and related to hormonal changes.
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| 66 | 2021-02-28 | feeling hot |
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come...
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tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
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| 66 | 2021-02-28 | numbness, tingling, cold extremities |
veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and...
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veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and Hands; Tingling in Arm and Hands; some pain in the injection arm; muscles pain in the hands; a freezing cold sensation in her hands/her hands were frozen for 3-4 seconds; I would wake up with one hand completely numb; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included osteopenia and osteoporosis. She was shrinking, her height was about 5 feet 5 inches, she used to be 5 feet 7 inches. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]), fish oil, vitamin e nos (OMEGA 3 [FISH OIL;VITAMIN E NOS]), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). It was reported that on 09Jan2021, she received the first dose of the vaccine. She started to feel tingling and numbness in both hands the same day after the vaccine was administered. She states she also had some pain in the injection arm and that the numbness/tingling was off and on and traveled to her arms occasionally. She states, "I would wake up with one hand completely numb and it was worse the first 15 days but is getting better and is a little less than before." She states she would have a freezing cold sensation in her hands occasionally and she states her veins were more prominent and visible in her hands/arms around the 13th day after getting the vaccine. She further reported that when she received the vaccine, that same afternoon she started feeling a tingling sensation in the hands and arms, also a sensation of numbness like electrical accompanied with muscle pain. The Numbness and Tingling was on and off and well as the muscles pain in the hands. It was more noticeable 13-14 days later now. She would be sleeping at night and would wake up because of the sensation in the left hand or on the other right hand. The hands would wake her up. She provides an example of its like when your foot is asleep with the pins and needles, because you had your foot squished under for a while, like the foot falling asleep but in this case she wasn't doing anything and would have that feeling. Once or Twice when having breakfast she noticed that her hands were frozen for 3-4 seconds. After the 13 or 14 days, things are milder but now she still has the sensation, its not so often but milder. She also notices the veins in her hands are still swollen in the arms, its like the veins popped up. She is still having this. She is concerned since she is suppose to get second injection on 30Jan2021, she is concerned if she should still it. She is nervous. She clarifies that the first dose was on 09Jan2021 at 10 or 10:15 AM. On the same day is when she started noticing the Numbness and tingling in the Hands and arms on 09Jan2021. She noticed the Veins popping on 22Jan2021. Caller clarifies that she has no side effects in the legs, she was just providing that comment as an example. The outcome numbness in arms and hands, tingling in arm and hands, wake up with one hand completely numb, was recovering; pain in the injection arm, muscles pain in the hands, freezing cold sensation in her hands was unknown; and veins in her hands are still swollen in the arms was not recovered. The reporter assessed the events as non-serious.
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| 66 | 2021-03-01 | muscle twitching |
1/19/2021 vaccination *continued symptoms from 1st vaccine. Twitching in legs, can see the twitches ...
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1/19/2021 vaccination *continued symptoms from 1st vaccine. Twitching in legs, can see the twitches in both legs. Weird strange pains that last 3-5 seconds on skin; come and go. Internist, Neurologist referrals; no diagnosis as of yet. Ongoing symptoms.
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| 66 | 2021-03-01 | night sweats | Headache, fever, chills, body aches, shortness of breath, severe night sweats |
| 66 | 2021-03-01 | pain in extremity |
My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache ...
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My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache and felt nauseous. I keep getting headaches on and off. Sometimes dizzy. The nausea is almost all the time. It has not improved. It has been one week.
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| 66 | 2021-03-01 | pain in extremity, feeling hot |
Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the...
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Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the following day in the afternoon the fever started (high 40/41C), nausea and intense body aches. These symptoms lasted until Monday (2 full days). Today is the 3rd day, and still with body aches a little nausea, very painful and warm arm but no fever. This was the first dose but the patient had Covid in March of 2020 ( at the time all the symptoms mentioned above were present with the addition of having lost taste and having some hallucinations. No problem breathing. Just letting you know for the purpose of statistics.
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| 66 | 2021-03-01 | flushing, tingling, feeling hot |
Twenty minutes post 1st vaccine dose on her left arm, patient began feeling light headed, tingling, ...
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Twenty minutes post 1st vaccine dose on her left arm, patient began feeling light headed, tingling, and warmth in her bilateral forearms. She then developed tingling at the tip of her tongue and had facial flushing. She developed rashes (hives in bilateral UE). She was brought for evaluation. Benadryl 50mg was given, Vitals taken and water was provided as well. She denies any SOB, CP, swelling or numbness. Physical exam: S1,S2, CTA, hives positive in bilateral UE, facial flushing, and neuro exam WNL. She reports her daughter had the Moderna vaccine a few weeks ago and developed full blown anaphylaxis. Her second daughter also had an allergic reaction to the MMR vaccine. She denies any history of allergic reaction to vaccines herself but does report allergies to several medications. About 10 mins post Benadryl administration, facial flushing resolved and the rashes in her forearms began to improve as well. Patient was recommended transport to the hospital/ER but she declined. She was instructed to contact her PCP for further evaluation. She was informed her second vaccine will have to be administered at an ER or facility that provides higher level of care. She was escorted to her vehicle to meet her husband.
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| 66 | 2021-03-01 | pain in extremity |
With the first shot hands started itching and continued for about a week and half. Did'nt go to Doct...
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With the first shot hands started itching and continued for about a week and half. Did'nt go to Doctor just took otc Bendryl.Arm was a little sore. The second shot about 35 minutes later hands started itching but not as bad as the first shot and I did'nt take any otc Bendryl this time .shot was in same arm (left) it was more sore than the first shot and next day mild headache and sore throat by 3rd day felt better.
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| 66 | 2021-03-01 | feeling hot |
Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with ...
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Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with headache, Felt extremely hot and Red rash appeared on my face on both cheeks and when I got up to leave I had weakness in my legs and was dizzy. Was given benedryl by the pharmacist who stated it look liked I had a reaction. Still had pain in left temple, headache, rash and dizzyness the next day along with scratchy throat. Headache and pain in temple mild after 3 days. I am concerned about second dose only because of shooting pains in my left temple.
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| 66 | 2021-03-02 | tingling |
About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swol...
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About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swollen, chest and abdomen tingling and tightness. Lasted about 5 minutes and then resolved.
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| 66 | 2021-03-02 | weakness |
I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous...
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I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.
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| 66 | 2021-03-02 | burning sensation |
On 2/19 @ 8:03pm, Red raised rash (bumps) across top of right breast. Burnt and itched. I took Bena...
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On 2/19 @ 8:03pm, Red raised rash (bumps) across top of right breast. Burnt and itched. I took Benadryl as soon as this happened. I Stopped itching and was getting better by 2/22/2021. (Bumps were not itchy, red at top, and stopped raising)
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| 66 | 2021-03-02 | migraine |
Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of...
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Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of very sharp pain in my head in addition to migraine. This went on for 30 hours. No treatment...just waited it out and used cool packs on head. Also had very enlarged tender nodes under my left arm which are going away.
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| 66 | 2021-03-02 | muscle spasms, breast pain |
burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left...
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burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported. Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged was recovering, other events was not recovered.
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| 66 | 2021-03-02 | feeling cold |
feel a cold sensation in my groin and in my upper thighs; This is a spontaneous report from a contac...
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feel a cold sensation in my groin and in my upper thighs; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at right arm on 31Jan2021 09:45 at a single dose for COVID-19 immunisation. Medical history included liver damage from hepatitis C. Concomitant medications were not reported. On 31Jan2021, the patient reported that she felt fine and walked back to her vehicle. As she began to drive home (after an additional 5 minutes), the patient began to feel a cold sensation in her groin and in her upper thighs. It continued for about 1/2 hour and then subsided. No treatment was received. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 66 | 2021-03-02 | migraine |
migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stu...
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migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stuff; has had diarrhea; diarrhea, had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing; vessels in hands really dilated and dark blue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9264), via an unspecified route of administration (arm left) on 30Jan2021 14:00 at SINGLE DOSE for to have some protection against COVID, at 66 years old. Medical history included connective tissue disorder and anti-cardiac lipid antibody problem; she is prone to blood clots from 2001. At that time, she was sent to the hospital and no one could figure out what it was. She was seeing the Rheumatologist and another person, and they knew something was going on and was given Prednisone (from 2001) because her tissues in the joints were swelling and she had trouble with speech. Patient also reported this as some weird connective tissue disorders already and some anti-cardiac lipid antibody problem. It was really weird and had not changed a bit since so she was kind of checking to see if anyone has reported anything like this. She reported that with this weird antibody problem, she is more prone to blood clots and has to be careful with medications with her blood she knows that some breast cancer medicines can do that. She stated this immune thing was never diagnosed. She also had migraine with globes of flashes of light, left eye (does not typically get migraines and has only had 1 in her life and she saw globes of lights in both eyes and had to go to the emergency room and was told it was an ocular migraine and this was also only in the left eye. This was long ago) from an unspecified date. Concomitant medication included low dose steroid (unspecified). The patient previously received flu vaccine on Sep2020 (AE none). No other vaccines were administered on the same day. On 30Jan2021, the patient experienced vessels in hands were really dilated and dark blue 5 hours after vaccination. On 30Jan2021, the patient also experienced IBS stuff and has had diarrhea the last couple of days after getting the COVID vaccine. She took Pepto Bismol to help and had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing. On 01Feb2021, the patient experienced migraine with flashes of light in left eye. It was further described as having a weird migraine with flashes of light in the left eye and she got the shot in her left arm and not sure if that makes any difference. She does not typically get migraines and has only had 1 in her life. The migraines started in the morning and lasted about an hour (as reported) and now they are gone and hopes they stay gone (reported as recovering). She wanted to know if she can take TYLENOL or ibuprofen for vaccine. She heard about people getting symptoms after the second dose not the first dose. Events did not require visits to the emergency room or physician office, but stated that if her vision become worse, she would go to the eye infirmary close by. The outcome of the events diarrhea and vessels in hands really dilated and dark blue, gets IBS stuff was not recovered. Outcome of the events migraine with flashes of light in left eye was reported as recovering.
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| 66 | 2021-03-02 | pain in extremity |
pt states that about a week after getting the covid vax that she has developed severe pain from the ...
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pt states that about a week after getting the covid vax that she has developed severe pain from the upper part of her right hip down to her knee. Pt had an appt w/ Dr. on 2/25/2021 regarding her symptoms. She was prescribed tramadol HCL 50mg and methylprednisolone 4mg. Pt states she is going to have to contact her doctor since this medicine is not working and she is still in severe pain. She has been off from work for a week but had to go back and states it is very difficult since she cant hardly get up and down.
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| 66 | 2021-03-03 | pain in extremity |
I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be e...
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I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be expected), muscle aches and pain, headache still, fatigue, shortness of breath and chills. By 8:30 pm I had a temperature of 101.7. I took some Tylenol and took my temperature again at 10:00 pm. It was 100.8. The next morning (3/3/21), I took my temperature again at 6:00 am. It was 101.1. I still had a headache, body aches and fatigue. I took more Tylenol and my temperature was down to 100.8 within an hour. Had a temperature most of the day ranging from 99.5 to 100.0. My normal temperature is usually 97.9. Still very tired. On Thursday March 4th, feeling better. Still a little tired. Temperature is 98.3.
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| 66 | 2021-03-03 | tingling, numbness | Patient had numbness and tingling on the left side of her face |
| 66 | 2021-03-03 | pain in extremity |
Vaccine given in right arm patient then proceeded to experience right arm pain, dizziness, diplopia,...
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Vaccine given in right arm patient then proceeded to experience right arm pain, dizziness, diplopia, and unsteadiness.
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| 66 | 2021-03-03 | pain in extremity, feeling hot |
bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt h...
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bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination. On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
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| 66 | 2021-03-04 | tingling |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 8:45 AM Ex...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/4/2021 8:45 AM Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Date: 3/3/2021 Subjective Patient is a 66 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm tingling. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH includes htn, takes 2.5 mg daily. She denies having issues with bp this am before coming. She ate breakfast earlier this am. No hx of diabetes. Hx of covid-19 infection in December. Not hospitalized. Still struggles with stamina since her illness. Evaluated in ED on 02/20/21 for chest pressure. Negative cardiac work up per pt. She is followed by her pcp. ALLERGY REVIEW OF SYSTEMS: Patient complains of malaise/fatigue (feels tired today.) and shortness of breath (chronic, not with exertion, tires easily. not changed from baseline.) Patient denies chills, fever, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, vomiting, abdominal pain and diarrhea L arm numbness/tingling down arm. Negative focal neuro deficits. : Previous Reactions: none Objective Vitals Vitals: 03/03/21 1023 03/03/21 1045 03/03/21 1115 BP: (!) 156/84 (!) 152/89 (!) 147/80 Pulse: 61 76 Resp: 16 14 SpO2: 99% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: General: No visual field deficit. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Normal range of motion. No muscular tenderness. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. Motor: Motor function is intact. Coordination: Coordination is intact. Gait: Gait is intact. Gait normal. Comments: +5/5 strength against resistance to upper and lower extremities. Psychiatric: Attention and Perception: Attention normal. Mood and Affect: Mood is anxious (slight anxious affect). Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Cognition and Memory: Cognition normal. Judgment: Judgment normal. Pt was taken to bathroom by LPN via wheelchair during her stay. She still felt weak upon her return. No dizziness/lightheadedness. She was given snacks and water x 2. Assessment/Plan Treatment included: water, snacks and reassurance/observation for about 40 minutes Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt improved with snacks and water. Discussed what to monitor and potential anxiety underlying as well. Pt to continue to monitor her bp at home and f/up with pcp if it continues to be elevated >140/90. Pt was able to ambulate out with ease and w/o dizziness/lightheadedness. Pt voiced appreciation of care today. APRN Electronically Signed 3/3/2021 11:21 AM
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| 66 | 2021-03-04 | pain in extremity |
Sore arm 1st two days Afterwards severe ache and could not lift arm for 3 days Reddish sore on my f...
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Sore arm 1st two days Afterwards severe ache and could not lift arm for 3 days Reddish sore on my foot. Very painful. Cannot put weight on it
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| 66 | 2021-03-04 | tremor |
Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Me...
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Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 66 | 2021-03-05 | numbness, throat numbness |
After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with t...
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After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with the 1st dose: mild-moderate numbness of nose, throat - all subsided by taking Benadryl that afternoon/eve. However, for the next 36-48 hrs after this 2nd dose, I experienced mild-moderate "flu-like symptoms": exhaustion, total body aches, scratchy throat, only slightly elevated temperature. This reaction was strong enough to prevent me from going to work for 2 days, sleeping 12-13 hrs at a time.
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| 66 | 2021-03-05 | tenderness | Redness in upper right arm Hot - warm to the touch Hard Tender to touch Itchy |
| 66 | 2021-03-06 | pain in extremity |
About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting...
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About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting very badly in both legs and had a very stiff neck and a headache. I have arthritis all over my body. I am not sure if the vaccine brought on the pain or if my arthritis caused the pain. But, I have not had that much pain with my arthritis before the 2nd dose vaccine. I was in so much pain I could not find a comfortable position in my bed to be able to go to sleep. I was awake until dawn. Finally, the pain became less and I was able to fall asleep and sleep about three hours. Today, 3-8-21, I feel fatigued and still have minor pain in my ankles. Like I said I have never been in so much pain before. The 1st dose vaccine only gave me a very sore arm.
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| 66 | 2021-03-06 | burning sensation | Achy, redness down my arm, swelling, burning itchy feeling. |
| 66 | 2021-03-06 | numbness |
Left Lip numbness with increasing blisters inside lower lip, began about 50 mins post injection, las...
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Left Lip numbness with increasing blisters inside lower lip, began about 50 mins post injection, lasted approximately 24 hours. Numbness bilateral feet from arches to toes, started approximately 4 hrs. post injection, lasted until next morning
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| 66 | 2021-03-06 | cold sweat |
Shot administered on 3/4/2021 at 10am. Woke up with chills and cold sweats at 3:30 am on 3/5/21. S...
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Shot administered on 3/4/2021 at 10am. Woke up with chills and cold sweats at 3:30 am on 3/5/21. Spend 3/5/21 on couch or in bed, fever spiked at 100.5 around noon. Symptoms disappeared around 4pm. Fatigued day 3 on 3/6/21. All better by Day 4 - 3/7/21
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| 66 | 2021-03-06 | pain in extremity |
Sore arm starting around 8 pm, and quite tired the following day. After a 2.5 hr nap, I was feeling...
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Sore arm starting around 8 pm, and quite tired the following day. After a 2.5 hr nap, I was feeling much better
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| 66 | 2021-03-06 | tingling |
Tingling, lightheaded, presyncope. BP readings: 97/62 (pulse 46), 98/60 (pulse 59). Given juice and ...
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Tingling, lightheaded, presyncope. BP readings: 97/62 (pulse 46), 98/60 (pulse 59). Given juice and water.
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| 66 | 2021-03-07 | muscle spasms, flushing, tremor |
24 hours after the injection I started to flush on my face neck and ears. I itched all over especial...
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24 hours after the injection I started to flush on my face neck and ears. I itched all over especially my eyes and throat. I was very agitated and shaking. I took an allergy Med at 2 pm and again at 7pm. The 2 Nd dose calmed me enough to get to sleep around 11pm. I was very close to going to the ER. In the morning I had a stomach ache like I have experienced before with and allergic reaction. Cramping pain , it lasted all day there was no nausea. The 3 day a headache that seemed appropriate for the vaccine.
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| 66 | 2021-03-07 | difficulty speaking |
After observation period, patient went to POV and experienced diffuse pruritic (no hives or rash), c...
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After observation period, patient went to POV and experienced diffuse pruritic (no hives or rash), cough and shortness of breath, hoarseness and feeling of throat closing. Pt. used 5 puffs of albuterol. Pt. was transported via ATV to ED after administration of EpiPen. Pt. given Decadron in ED. Pt. has just started Prednisone taper and was instructed to complete it. Prescribed hydroxyzine and EpiPen. Discharged stable.
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| 66 | 2021-03-07 | weakness |
I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have ...
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I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have the strength and attention pan to continue cooking. I have also been suffering from Lingering episodes of sudden physical faintness and mental stupor. This is most noticeable after engaging in my normal walks of one mile or less.
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| 66 | 2021-03-07 | hot flush |
In patient reported "nausea and hot face". EMT evaluated. Pt's symtoms resolved after 23 minutes. No...
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In patient reported "nausea and hot face". EMT evaluated. Pt's symtoms resolved after 23 minutes. No emesis, no facial flushing, no respiratory distress. Pt was released at 3:09 pm. RN
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| 66 | 2021-03-07 | inability to speak |
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w...
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Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
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| 66 | 2021-03-07 | numbness |
Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer....
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Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: 10T EL 9262), via an unspecified route of administration on 05Feb2021 13:30 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included hypersensitivity allergies: Yes. Concomitant medications included ashwagandha, ascorbic acid (VIT C). On 06Feb2021 04:00, the patient experienced Sore at injection site and numbness to elbow. The patient did not receive treatment for the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
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| 66 | 2021-03-08 | weakness, tingling |
Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth...
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Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth burning and pain Tingling in hands and feet, loss of appetite.
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| 66 | 2021-03-08 | feeling of body temperature change |
Client reported abdominal discomfort 10 minutes after vaccination. Stated, "I think that my sugar i...
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Client reported abdominal discomfort 10 minutes after vaccination. Stated, "I think that my sugar is low." Blood sugar 114. Complained of feeling hot and cold. Exited car and spat out clear secretions. Client observed for 30 minutes. Reported that abdominal discomfort felt "A little better." Declined further observation. Driven off site by her son.
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| 66 | 2021-03-08 | pain in extremity | Fever , My bones hurt legs and arms low part of my back My head hurt so bad sick to my stomach |
| 66 | 2021-03-08 | pain in extremity |
I had the normal, mild arm soreness after administration, Then two weeks and 2 days later, I had sev...
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I had the normal, mild arm soreness after administration, Then two weeks and 2 days later, I had severe pain , swelling and pain at the injection site, and unable to move arm to the arm away to the side or forward of the body.
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| 66 | 2021-03-08 | pain in extremity |
Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with seve...
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Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with severe pain and swelling in legs and rash from feet to buttocks/back area. Patient went to hospital on 3/7/21; negative for blood clots, lab work was normal; Prescribed Hydroxyzine, PCN-(for mild sore throat), Multi V, Areds 2
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| 66 | 2021-03-08 | pain in extremity |
Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of the...
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Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of these were bad, just noticeable, and seem to have resolved in 2 days.
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| 66 | 2021-03-09 | discomfort |
I had breast cancer in 2003 and had to have a left breast removed and half of the lymph nodes were r...
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I had breast cancer in 2003 and had to have a left breast removed and half of the lymph nodes were removed. Due to the surgery I developed lymphedema and i have to wear a compression sleeve and glove seven days a week. A few minutes after the injection i was reading the reaction list and caught that it might cause lymph nodes to swell and about the time i was reading it i felt pressure in left arm i looked at it my arm and hand swelled to the point my hand and fingers turned blue i started to massage my arm and called the nurse she told to keep massaging after 30 minutes sitting there the arm was still swelled the nurse released me and told me if it got worse go to the emergency room. I came home kept massaging and elevated my arm about the time i went to bed around 9:00pm the swelling came down. The arm was normal when i woke up
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| 66 | 2021-03-09 | pain in extremity |
My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, ...
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My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, I had to keep it my side. I also had a headache. 9 days after the injection I had extreme fatigue and wasn't myself. During the night My right arm/shoulder started throbbing and hurting again. I was cold and lightheaded. When I woke up I was fine!
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| 66 | 2021-03-09 | tingling | Patient stated her chin and lips felt "tingly" she had a rash developing on her chin. |
| 66 | 2021-03-09 | flushing |
Progress Notes COVID VACCINE CLINIC 3/3/2021 Patient is a 66 y.o. female who was seen at Vaccine...
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Progress Notes COVID VACCINE CLINIC 3/3/2021 Patient is a 66 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience feeling flushed/nausea. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and vomiting. She reports she took her coreg 25 mg dose torsemide 20 mg doses this am. She did eat toast and yogurt around 7 this am. Past Medical History: Diagnosis Date ? Biventricular ICD (Medtronic) implanted on 8/19/14 8/20/2014 ? Depression ? Depressive disorder, not elsewhere classified ? GERD (gastroesophageal reflux disease) ? Heart failure (HCC) LVEF 40-45% by ECHO 1/2012. ECHO 11/13 LVEF 50-55%. LVEF 37% by nuclear stress test 2/20.14. ECHO 4/2014 LVEF 30-35%. LVEF by echo from 3/2017 LVEF 50-55%. ? hospitalization Admit on: 20111020; Diagnosis: Acute respiratory failure, acute on chronic systolic and diastolic heart failure; at: Stormont-Vail HealthCare; ? Hypertension ? LBBB (left bundle branch block) ? Mitral regurgitation Moderate secondary to annular dilation ? NICM (nonischemic cardiomyopathy) (HCC) Cardiac cath from 10/2011 normal coronary arteries. Nuclear stress test 2/2014 no ischemia. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, ear pain, sore throat, eyes watering, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, blood in stool, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/03/21 0920 03/03/21 0928 03/03/21 0937 03/03/21 1000 BP: 97/50 97/57 112/60 104/58 Pulse: 96 86 68 Resp: 18 16 14 Temp: 98.4 °F (36.9 °C) SpO2: 100% 100% 100% Blood Sugar 71 collected at 0922 Blood sugar 103 collected at 0945 Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not diaphoretic. Comments: Flushed. Negative for diaphoresis Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Coloration: Skin is pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water, snacks and reclined Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Greatly improved after water/snack/reclining. Pt observed for 45 minutes in the bay. She feels comfortable going home. Her blood pressure drop may be related to her taking two medications that affect her bp as mentioned above. She's improved with hydration and snack. Recommended that she rest, monitor her bp at home. If symptoms worsen or returns, recommend evaluation in ED. Otherwise follow up with pcp office. Pt wheeled out with RN and husband. Pt voices appreciation of her care today.
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| 66 | 2021-03-09 | pain in extremity |
having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the...
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having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the night; body aches/achy; chills (no fever); nausea; got the sore arm; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 (not clarified further)), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation and loratadine (CLARITIN), via an unspecified route of administration from 03Feb2021 at an unspecified dose for unspecified indication. Medical history included ongoing High cholesterol and Sleep disorder, both from unknown date. Concomitant medication included alprazolam (XANAX), calcium (CALCIUM), cyanocobalamin (VITAMIN B12), Multivitamin, taking a statin to prevent high cholesterol and L-methylfolate, stated it is like a folic acid drug. Because the patient really can't take anti-depressant she reacted to them all (Unspecified Medications), so that worked for her and helped her to keep up her spirit. The patient reported her side effects. She didn't want to interfere with anything but she was having lots of Gastrointestinal issues which were inconvenient. She was up in the middle of the night, happened not within 48 hour after the first dose of the Pfizer vaccine but around 60 hours after the vaccine, early this morning (06Feb2021) like around 2 am. The patient was having a reaction after the vaccine but they seemed to be like delayed reactions. Not anything with breathing, she had gastrointestinal stuff going on. The patient had chills, no fever, body aches and she was really going to the bathroom nonstop in the night. It seemed to have been like 2 days after she got the shot like they were worst yesterday (05Feb2021). And she experienced achy, chills, nausea, diarrhea and sore arm in Feb2021. She would like to take TYLENOL and IMODIUM and she didn't know what she could take because she didn't want anything to interfere with that as she had been reading a lot. The patient wanted information on IMODIUM to prevent diarrhea, TYLENOL for body aches, chills (no fever), and FLONASE for sinus. The patient did not receive any treatment for the events. The patient actually didn't even take, that morning that day when she was getting the shot, she called the pharmacist to see if she could spray her nose with the FLONASE for sinus and he told her that he didn't think it was a good idea and that maybe she should just take CLARITIN, so she did. But she took CLARITIN that morning (03Feb2021) and she was hoping that didn't interfere. She was just nervous about it as she didn't want that to interfere with the work that it was. The patient was still suffering, less, like she didn't have the diarrhea anymore. She still had a little achy. She did get the sore arm but only for one day, so it wasn't so bad. The action taken in response to the events for loratadine was unknown. The outcome of event diarrhea and got the sore arm was recovered on an unspecified date in Feb2021, of event achy was recovering, of other events was unknown. Information on the lot/batch number has been requested.
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| 66 | 2021-03-09 | weakness |
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si...
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injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-03-10 | burning sensation, tremor |
About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 min...
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About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 minutes. I did not have this with the first vaccine. Around 7pm I started to develop chills which over a few hours I started to have shaking from the chills. I also developed a headache, Temperature 101.1, muscle weakness, pain at insertion site and diarrhea. I used Tylenol and Advil. Around 0500 no longer experienced a temperature and chills had lessened. Continued on day two to have slight chills and headache along with weakness. Day 3 minimal weakness
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| 66 | 2021-03-10 | pain in extremity, numbness, tingling |
About 3 hours after vaccine administration I experienced severe numbness and tingling in entire Righ...
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About 3 hours after vaccine administration I experienced severe numbness and tingling in entire Right arm and hand, pain at very top of right arm. Fatigue started the next day (3/3/2021), worsened each day through day 6. Numbness and tingling also lasted 6 days.
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| 66 | 2021-03-10 | migraine |
Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headac...
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Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headache lasted for 4 days Severe exhaustion 4 days No appetite 4 days Day 5 just wiped out!
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| 66 | 2021-03-10 | flushing |
Patent is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30...
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Patent is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW6208 on 3/11/2021. The patient experienced the following reaction(s) during the immediate of observation: 12:00p: Patient c/o "lightheadness and feeling flushed" during observation period. Patient was treated/managed as follows: 12:02p: Patient taken to treatment area. 12:05p: VS BP 140/90, HR 71, RR 18, O2 sat 97% on room air. Patient reports feeling better. 12:15p: VS BP 126/84, HR 75, RR 18, O2 sat 96% on room air. 12:22p: Patient escorted to car by husband and RN. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
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| 66 | 2021-03-10 | pain in extremity |
pt states that she woke up w/ headache, nauseated, SOB, and pain in left arm. she says these sympt...
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pt states that she woke up w/ headache, nauseated, SOB, and pain in left arm. she says these symptoms come and goes in waves. pt went to urgent Care on 3/8/2021. Pt was ordered Chest X-Ray that came back normal. Rapid Covid Test w/ negative results. All vitals were good. Pt was prescribed an inhaler. Pt also went to her local pharmacy and took another Covid test on 3/10/2021 w/ pending results and then FU w/ PCP.
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| 66 | 2021-03-11 | unresponsive to stimuli, tremor, seizure |
Had a Seizure and was transported to hospital by Ambulance, was admitted and kept overnite to run te...
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Had a Seizure and was transported to hospital by Ambulance, was admitted and kept overnite to run test. Shaking and Unreponsive.
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| 66 | 2021-03-11 | pain in extremity |
Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost ap...
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Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost appetite.
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| 66 | 2021-03-11 | flushing |
c/o facial and tongue swelling, tongue tingling, flushed cheeks, Hypertensive at 207/93, HR 50s, O2s...
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c/o facial and tongue swelling, tongue tingling, flushed cheeks, Hypertensive at 207/93, HR 50s, O2sat 98. Recommended EMS transport, patient/SO declined transport. Signed AMA and EMS form. Significant other drove patient to ED for further evaluation. Received normal saline fluids, famotidine 40 mg PO x 1, hydroxyzine 25 mg IM X1, and Methylprednisolone 125 mg IM X1 in the ED. Discharged from ED 3/8/2021. Patient contacted on 3/11/2021 and states feeling a little better since visit to the ED on 3/8/2021. Still feels like throat and face are a little "tight" but improving.
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| 66 | 2021-03-12 | facial paralysis, bell's palsy |
Developed Bells Palsy, distorted face, droopy mouth and eyelid, not able to fully close left eye and...
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Developed Bells Palsy, distorted face, droopy mouth and eyelid, not able to fully close left eye and mouth not functioning correctly. Given Prednisone and ointment and lubricant for eye Afraid to get second shot! Need recommendation!
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| 66 | 2021-03-12 | migraine |
Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and ...
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Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and extreme bright light, feeling of fainting, quick nauseous feeling.
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| 66 | 2021-03-12 | grand mal seizure | Grand mal seizure. 1st one in 15 years. |
| 66 | 2021-03-13 | discomfort, weakness |
5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I...
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5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I wasn't interested in eating, the pressure/discomfort feeling was increasing and I was uncomfortable all over and unable to get to sleep. Around 2 or 3 am, I had an episode of violent vomiting, which did not serve to make me feel any better. From that point on, for the next 24 hours, I continued to feel sick, extremely tired, and ached all over. I couldn't get comfortable, didn't feel like eating or even drinking, and had no energy, even to not being able to sit up and watch TV. As the 7th day continued, I threw up mid-day, was able to sip my way through 2 glasses (water, tea), and eat a few crackers. I felt very dizzy when I walked. I checked my temperature twice and didn't seem to be running a fever, which surprised me. I didn't take any pain relievers, as I felt I would just throw them up. By evening, however, I was able to take 2 ibuprofen, take a hot shower, and slept pretty well that night. By the 8th day, the aches were pretty much gone and I was able to eat soft foods and get rehydrated. I felt a little weak, still tired, and wobbly, but was clearly over the worst of it. By the 9th day, I was back to normal.
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| 66 | 2021-03-13 | weakness |
Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs,...
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Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs, chills. Took Tylenol. Woke up around 7am. Not feeling any better. The tip of my tongue felt as if it was dipped in hot sauce. Slept most of the day. Chills came back. Took Tylenol. Today (3/14), better, but still weak. Under my tongue is very sore.
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| 66 | 2021-03-14 | flushing, feeling hot |
Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; ...
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Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and neck red, swollen and hot to the touch.; Similar to a Cortisone flush.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female non-pregnant patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration in the left arm on 29Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes mellitus, renal disorder fibromyalgia and hypersensitivity (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received multiple concomitant medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 at 14:00 the patient expereinced face and neck red, swollen and hot to the touch, similar to a cortisone flush. On 31Jan2021 the patient underwent lab tests and procedures which included blood pressure measurement: normal and body temperature: 97.3 (normal). The patient was treated for face and neck red, face and neck red, swollen and hot to the touch similar to a cortisone flush with 50mg of benadryl (MANUFACTURER UNKNOWN). The outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.
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| 66 | 2021-03-14 | muscle spasms |
Felt like I had food poisoning. Intense diarrhea, intense cramps, nauseous (thought I was going to ...
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Felt like I had food poisoning. Intense diarrhea, intense cramps, nauseous (thought I was going to throw up), body temperature kept going up and down (cold one minute and hot the next minute) - Started at 10:00 p.m. and lasted close to an hour. After that, felt extremely light headed
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| 66 | 2021-03-14 | pain in extremity, bell's palsy |
I rec'd my first Covid vaccine shot on 3/3/21 in my right arm. I had soreness in the arm for 2 days...
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I rec'd my first Covid vaccine shot on 3/3/21 in my right arm. I had soreness in the arm for 2 days afterwards. On Wednesday, March 10, 2021, I got severe pain behind my left ear and down the left side of my neck. Saturday morning, March 13,2021 my lips were numb and I was not blinking my left eye and I could not close my left eye. I went to the doctor Monday morning, March 15,2021 and she confirmed Bell's Palsy. Blood was drawn and I was given prescription medication.
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| 66 | 2021-03-14 | pain in extremity |
I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My ...
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I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My breathing started to get worst. I already was having problems since I had Covid in January into February. A week later I woke up and felt very sick, started throwing up all day into the night, had 101 fever and chills. That lasted about a day and a half. I still felt sick for the next two days. I continue using having breathing problems worst than before the shot. I am also very exhausted.
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| 66 | 2021-03-14 | pain in extremity |
Intense arm ache evening after the vaccination. Woke the next morning with a splitting headache and...
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Intense arm ache evening after the vaccination. Woke the next morning with a splitting headache and fever. Headache subsided after taking one Tylenol, but fever maintained through 03/10/2021. It took 2 more days before it finally returned to normal.
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| 66 | 2021-03-14 | muscle spasms | Nausea, cramping, gas, burping and flatulence. Duration: 2 hours |
| 66 | 2021-03-14 | weakness |
got my first dose at 12:45 pm on Friday the 12 th of March. At 12:30 am Saturday morning i started...
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got my first dose at 12:45 pm on Friday the 12 th of March. At 12:30 am Saturday morning i started throwing up. I threw up every hour for a total of 3 times. last time was 2:30 am. My stomach was gurgling and it hurt to press on it. and i kept belching. Had no energy. On Saturday was able to sleep 3 hours in my rocker until 2:15pm when i threw up again. Had no energy. Had chills the first day starting about 4 pm Friday after my shot. Called the emergency room to see if I could take antinausea pills I had . Talked to my doctor and he said I was allowed. It was ondansetron 4 mg. I took one at 3 pm and started feeling less weak.
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| 66 | 2021-03-15 | numbness |
1. Baseball size swelling in arm pit on arm where shot was given. 2. Numbness of left foot that last...
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1. Baseball size swelling in arm pit on arm where shot was given. 2. Numbness of left foot that lasted for 4 hours on day of shot and intermittently since Saturday but able to walk without issues.
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| 66 | 2021-03-15 | night sweats |
Chills and body aches at 8pm evening of shot. Temperature 99.6. Hot sweats during the night. Upon wa...
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Chills and body aches at 8pm evening of shot. Temperature 99.6. Hot sweats during the night. Upon waking up temperature was 102. Body aches persist.
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| 66 | 2021-03-15 | numbness, pain in extremity |
Morning after 1st shot awoke with sore back and neck. Appeared swollen like inflammatory response to...
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Morning after 1st shot awoke with sore back and neck. Appeared swollen like inflammatory response to shot as day of shot felt fine. I did go to Physical Therapy that morning for knee but didn't do anything out of the ordinary since had been doing that for weeks. That night was in so much pain couldn't get into bed. Pain radiated from back to hip to thigh, and down shin, with no feeling in shin. Muscles very tight and was very odd. Seen by provider the next day and received Toradol shot. That did not provide relief so went to local ER. X-rays revealed pinched nerve. Now maybe that was because of the inflammatory response or pure dumb luck. Still in lot pain and will receive cortisone shot next week 10 days after 2nd dose today. Providers feel not related, but one provider said if my back was inflamed even a simple reaching for glass in cupboard could pinch nerve. I was not going to report but then saw someone posted on (social media) had muscle pain and spasms which sounded like what I had. I believe my inflammatory response to shot drove me to the pinched nerve situation. Been in pain for weeks and had to go to 2nd shot in wheelchair.
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| 66 | 2021-03-15 | pain in extremity |
Sore arm; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline an...
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Sore arm; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; This is a spontaneous report from a contactable pharmacist. This was regarding patient 2 of 6. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration date: Apr2021, NDC number: 59267-1000-01), via an unspecified route of administration in left arm on 03Feb2021 at 0.3 mL, single for prevention/ COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1686, Expiration date: Mar2021) at 0.3 ml, single dose in left arm for COVID-19 immunisation. Calling about COVID-19 vaccination. Yesterday (03Feb2021) they mistakenly used sterile water as a diluent and administered it to six patients, so she wanted to report that and talk to someone about what needs to be done. Caller states she thinks everyone getting the COVID shot was getting a sore arm on an unspecified date. This was the second dose. Caller wanted to know if they need to revaccinate those 6 patient again, so they are protected. The caller (pharmacist) stated that they reconstituted Pfizer COVID vaccine with sterile water instead of the normal saline and administered to 6 patients. Investigation assessment was none. The events were considered as non-serious by the pharmacist. The outcome of the events was unknown. A causal relationship between bnt162b2 and sore arm was assessed as being related by the pharmacist.
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| 66 | 2021-03-15 | numbness, nerve pain, night sweats |
muscle and nerve on both side of her face and the area along the back of both ears on the back head ...
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muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-03-16 | pain in extremity, difficulty speaking |
Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS call...
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Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS called to vehicle at 1527. RN arrived a few minutes later. Per EMS report: Patient complained of itching all over, trouble swallowing, throat tightness, legs hurting, and raspy voice. No hives present and injection site normal. Per EMS report VS- BP:165/81 P:100 O2: 98% on RA End Tidal CO2: WNL EMS administered 50mg Benadryl IM at 1541 and IV started. Departed in ambulance.
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| 66 | 2021-03-16 | flushing |
Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When o...
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Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When observation nurse was checking on patient to allow the to leave, resident complained of light headed. Patient brought to triage for evaluation. Patient reported they had a Vasovagal response 6 years ago. Vital signs were taken, all within normal limits. Ice pack was applied to back of neck, as patient felt flushed and juice was given. Patient said she did not eat breakfast when asked. Patient was observed being very restless and rubbing/scratching her arms, scalp and upper back. Rash was noted on upper back left side, NO hives. Benedryl 50 mg IM was given. Called patients friend, patient did not want emergency contact called for pickup. Patient's friend was willing to come and pick her up. Patient observed with diminished restlessness and itching. Patient reported a "tightness" in her neck muscles, almost like she had swollen glands. Patient was able to talk well, no c/o of SOB or difficulty breathing or itchiness of her throat. Patients friends arrived, informed of the incident. Patient was sleepy, rash was gone, patient denied any more itching, patient appeared more peaceful. Advised if she had any worsening symptoms or signs of a severe allergic reaction to call 911. Patient stayed in total for 90 minutes. Patient was assisted by nurse to her friends car.
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| 66 | 2021-03-16 | pain in extremity |
Patient was erroneously given Pfizer instead of Moderna for dose 2 on 3/5/21. Patient was contacted ...
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Patient was erroneously given Pfizer instead of Moderna for dose 2 on 3/5/21. Patient was contacted to notify patient of error on 3/5/21. Noted slight soreness in arm but otherwise felt fine during the call. MD called patient on 3/9/21 for follow-up with patient to discuss error.
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| 66 | 2021-03-16 | night sweats |
The evening after patient received vaccine, she started to develop low grade fever and urticarial ra...
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The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
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| 66 | 2021-03-17 | numbness |
About 5 minutes after the vaccine, pt develop left arm weakness and left facial numbness. States sh...
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About 5 minutes after the vaccine, pt develop left arm weakness and left facial numbness. States she has no pain in her arm. Denies chest pain, dizziness, swelling, itching, rash or sob.
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| 66 | 2021-03-17 | pain in extremity |
Arm was sore for a day; This 66- year-old female patient contactable consumer (reported for herself)...
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Arm was sore for a day; This 66- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 13Feb2021 at 10:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Thyroid problem. Concomitant medication included: Synthroid 88mcg, Synthroid 75mcg, Ibandronate. On 13Feb2021 at 5:00PM, the patient reported that her arm was sore for a day. The clinical outcome of the event arm sore was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 66 | 2021-03-17 | burning sensation |
I awoke during the night I received my vaccine with some mild itching of my extremities, but no rash...
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I awoke during the night I received my vaccine with some mild itching of my extremities, but no rashes. This disappeared by the morning. On 3/11/21, I discovered an enlarged lymph node near my left collar bone. As of today, 3/18/21, the lymph node is still palpable and hasn't changed.
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| 66 | 2021-03-17 | tremor, tingling, numbness |
On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had ...
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On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had parkinsons disease. The heaviest shaking was of the right arm and hand which was where the vaccine was administered. Made my way to bedroom on my walker to tell hubby I was not feeling well, Took blood pressure which was elevated and my heart felt like it was beating out my chest, Bllod pressure was elevated and so was pulse. Shaking continued and breathing was shallow, Waited 10 minutes and retook vitals, BP and pulse up more, Called 911, Paramedics came and monitored my vitals several times which after 20 minutes started declining, Could not say conclusively if was vaccine related. Elected due to Covid not to be transported to hospital and signed off on declination, Was told by paramedics to call 911 again if symptoms reoccurred and go to hospital, In successive days I still continue to have pin-prick feelings and numbness in my right fingers, More difficult to walk than usual,
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| 66 | 2021-03-17 | flushing, seizure |
Scared of needles. Syncope, flushing/sweating. BP 111/51 (pulse 90). Patient placed in supine positi...
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Scared of needles. Syncope, flushing/sweating. BP 111/51 (pulse 90). Patient placed in supine position - appeared to show signs of convulsion. Taken to the ED.
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| 66 | 2021-03-17 | tingling |
Tinkling, like being pricked with needles, under my left ear, jawbone area. Felt a lump & swelling ...
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Tinkling, like being pricked with needles, under my left ear, jawbone area. Felt a lump & swelling at this location. Very tender to touch. Swelling & lump went down in size the following day, Sunday (first notice Saturday night).
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| 66 | 2021-03-17 | weakness | heart racing, heartburn, have no energy |
| 66 | 2021-03-18 | seizure |
12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transport...
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12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transported to EMS area of observation area; in wheelchair lost consciousness and had brief 15-20 second seizure 13:10 Repeated bouts of emesis. Patient had marked pallor and diaphoresis 13:35 EMS transport arrived, placed IV, gave phenergan, and transported via ambulance to Hospital Center
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| 66 | 2021-03-18 | flushing, feeling hot |
3-18-21 5:30PM PT STATES SHE FEELS'VERY HOT SINCE GETTING SHOT.' FACE AND CHEST ARE FLUSHED. A/O, W...
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3-18-21 5:30PM PT STATES SHE FEELS'VERY HOT SINCE GETTING SHOT.' FACE AND CHEST ARE FLUSHED. A/O, W/D, NO RESP DISTRESS. NO SOB OR DYSPNEA, NO PAIN, NO EDEMA OF THROAT/TONGUE. BOTTLE OF WATER GIVEN. 5:45PM PT STATES SHE 'FEELS BETTER NOW'. COLOR IMPROVED. 5:53 HUSBAND HERE TO DRIVE PT HOME.NO ACUTE OR OBVIOUS DISTRESS. 3-19-21 3:44PM TC: PT STATES 'HOT FLUSHED FEELING GONE NOW'.
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| 66 | 2021-03-18 | inability to speak, pain in extremity |
I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on ...
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I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on the evening of February 14. I had no side effects from the first vaccine and just soreness in arm of injection after the second vaccine. I realize that the stroke could coincidental but thought I should report it just in case for information in the event others had similar event.
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| 66 | 2021-03-18 | tremor |
On 2/14 started experiencing heart palpitations, tremors, sweating No previous history of anxiety...
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On 2/14 started experiencing heart palpitations, tremors, sweating No previous history of anxiety or depression
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| 66 | 2021-03-18 | pain in extremity |
arm pain; mouth had ulcerations; Unusual taste sensations; tongue felt swollen; tiredness; headache/...
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arm pain; mouth had ulcerations; Unusual taste sensations; tongue felt swollen; tiredness; headache/her head would be pounding; Weird coating on tongue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date: unknown) at 66-year-old vaccination age intramuscularly administered in the left arm on 01Feb2021 as a single dose for covid-19 immunisation. Medical history included obesity just barely qualifies under that began 6 years ago (2015), allergy to one type of Penicillin VK and blood pressure (blood pressure abnormal). The patient has no familial medical history. Concomitant medication included losartan start and stop date were unknown for blood pressure. The patient has no previous immunization with the Pfizer vaccine considered as suspect and did not have other additional vaccines administered on the same day as the covid-19 vaccine. The patient reported that he experienced mouth ulcerations, tongue swelling, arm pain, tiredness and headache. The patient further reported that for the first day or two (02Feb2021 09:00), she had tiredness and headache and that was all resolving. Then on 04Feb2021 06:00, she woke up and the rest of her mouth had ulcerations. Her tongue felt swollen and she had a really weird coating on tongue (also reported to have started on 02Feb2021 06:00), along with really unusual taste sensations that lasted for 4 days and calmed down. It is still continuing on a very reduced level. She is still having weird problems with taste and her tongue feels different. She stated that the tiredness improved on 03Feb2021 and the headache was intermittent until 05Feb2021. The tongue swelling has not resolved all the way, it is intermittent. She will feel ok one day, and the next day, it will be back. She mentioned that the patchy white coating on tongue only lasted about a day, but she still has the feeling intermittently along with the taste sensations, but the white part is gone. The patient also stated that when she would wake up in the morning, her head would be pounding. That is the kind of symptoms she would have if she didn't take her blood pressure medication, but she did take her medication. The patient had arm pain on an unspecified date. The outcome of the event taste abnormality was not recovered, as for the event arm pain was unknown while the outcome of the other events was recovering.
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| 66 | 2021-03-19 | tingling |
About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sens...
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About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sensation, thready pulse 80/min, felt occasional palpitations, Couldn't get accurate BP because it was faint and hard to hear pulse. I took Benedyl 25mg orally at 10 pm.
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| 66 | 2021-03-19 | pain in extremity | Headache, chills, sore arm |
| 66 | 2021-03-19 | pain in extremity |
I felt dizzy and lightheaded right after the shot. That night my arm was hurting me very badly. I st...
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I felt dizzy and lightheaded right after the shot. That night my arm was hurting me very badly. I started to feel feverish and extremely fatigued the next day. I also felt achy. I have intermittent very mild headaches and just feel lousy.
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| 66 | 2021-03-19 | tingling |
My right arm has been knotting up at injection site. It also goes to sleep from the shoulder to the ...
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My right arm has been knotting up at injection site. It also goes to sleep from the shoulder to the elbow. This has been going on for over a week.
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| 66 | 2021-03-20 | weakness | N/v, confusion, headache, chills, weakness |
| 66 | 2021-03-20 | pain in extremity |
Symptoms/reactions started one week after I received the vaccine. I stated having severe pains in m...
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Symptoms/reactions started one week after I received the vaccine. I stated having severe pains in my left arm from the elbow up to my shoulder and left side of neck, with the site of the shot/vaccine being very tender and extremely painful. I can't hold my hand down, it is very sensitive, I can't turn my head around or even tilt my head back to gargle my throat.. I have to hold my hand in a certain way because it hurts terribly.
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| 66 | 2021-03-20 | breast pain | Upper back and left side, breast pain. |
| 66 | 2021-03-21 | pain in extremity | Chills, aches, fatigue, nausea |
| 66 | 2021-03-21 | speech disorder |
Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty form...
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Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty forming words. Words were very garbelled. Extremes sweatness. chills.
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| 66 | 2021-03-21 | pain in extremity | Left arm swelled and was sore. I took ibuprofen, applied a heating pad. |
| 66 | 2021-03-21 | pain in extremity | SEVERE PAIN IN THE ARM, SEVERE HEADACHE, MUSCLE, JOIN PAIN AND HIGH HEVER FOR 3 DAYS (38.8 - 39.3 C) |
| 66 | 2021-03-21 | migraine | Severe migraine and extreme muscle pain from elbow to hands (both arms) |
| 66 | 2021-03-22 | facial paralysis, bell's palsy, facial pain, weakness, slurring |
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain ...
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Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21. Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
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| 66 | 2021-03-22 | weakness |
I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could ...
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I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could not properly walk. After trying to drink a bit of water, fainted and vomited it all back up. I was weak and tired. Slept or rested all day and by late afternoon was able to hold down some toast and by evening symptoms had resolved. Clearly, I am not sure that this was vaccine related since it occurred 2 wks after vaccination but felt should be reported.
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| 66 | 2021-03-22 | numbness |
Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had t...
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Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had these adverse effects on and off for over a week. The second week after the shot felt numbness in my face. After about one month these events are mostly gone. Still have occasional fire bursts under my skin but only one or two not my entire arms or legs.
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| 66 | 2021-03-22 | tremor | headache, dizzy, lightheaded, shaking, fatigue, fever |
| 66 | 2021-03-23 | feeling cold |
About two weeks and two days after I had the second vaccine, I felt a little chill and had a very s...
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About two weeks and two days after I had the second vaccine, I felt a little chill and had a very slight scratchy throat and a very slight cough on and off for about five days and I was wondering if what I had experienced was a delayed reaction to the vaccine even though it was two weeks and two days after I had received it? I had associated the reaction to being ?better? than having a cold because when I get colds, it would start with a very bad sore throat and then would become a full-blown cold with very bad coughing and sometimes I would develop bronchitis. I thought that the reaction that I had was quite mild.
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| 66 | 2021-03-23 | weakness, pain in extremity |
Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple p...
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Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple parts of my body: wrists; left groin and leg; neck/shoulders; lower back and had a headache. All of these areas were thrubbing and interrupted sleep. Also was very weak. Was difficult to get out of bed or a chair and to walk. Also had loss of appetite. At no time, did I have a temperature.(Note: I play tennis so was very active early in the week). The course of the symptoms has lasted 96hours but now seems to be subsiding. After 48 hours of inability to do any normal life activities, I contacted my physician who prescribed a cordtisone shot and anti-inflamatory medication, which I've taken for 2 days.
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| 66 | 2021-03-23 | pain in extremity |
Arm pain for one day could not lift arm above chest following vaccine on 3/10/2021. Treated with ice...
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Arm pain for one day could not lift arm above chest following vaccine on 3/10/2021. Treated with ice. Intense lower abdomen pain started on 3/17/2021 Went to ER. Kidney infection Treated with IV Morphine Iv Fluids, Cefuroxime
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| 66 | 2021-03-23 | flushing |
Today at about 11: 30 AM, I took an Amoxicillin for gingival irritation. I have taken this medicine ...
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Today at about 11: 30 AM, I took an Amoxicillin for gingival irritation. I have taken this medicine before , but this was the first time since getting my Covid Vaccine. About one hour later, I began having intense itching of both hands, followed by diffuse flushing and pruritus and slight swelling around my face and eyes and a little feeling of throat irritation, but without SOB, wheezing or tongue swelling. My vital signs stayed stable, including a normal oximeter reading. I took a 180 mg Fexofenidine and used some OTC Hydrocortisone Cream on my hands when the first symptoms started. When the other symptoms progressed , I took 24 mg Methylprednisolone oral tablets and 25 mg liquid Diphenhydramine and my husband drove me to the ER, to be close in case I developed difficulty breathing. After about 30 minutes the symptoms stopped worsening and gradually resolved. I didn't go to ER
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| 66 | 2021-03-23 | pain in extremity |
Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headach...
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Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headache and nausea. Took Tylenol. Rested 2 hours, still some dizziness, headache, nausea. Improved by 2:30 pm after more rest. I had arm and neck pain , nausea and fatigue for 4 days after the vaccination.
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| 66 | 2021-03-23 | discomfort, weakness | body feels heavy and weak. Evaluated by EMS-Cleared |
| 66 | 2021-03-24 | difficulty speaking |
I have tinnitus, however, three days after receiving the Pfizer covid- 19 vaccination, my tinnitus g...
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I have tinnitus, however, three days after receiving the Pfizer covid- 19 vaccination, my tinnitus got noticeably louder. The loudness subsided somewhat six days later, and is still continuing.
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| 66 | 2021-03-24 | numbness and pain in extremities |
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s...
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Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-03-24 | pain in extremity |
Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable co...
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Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient (weight: 107.95 kg, height: 165 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 04Mar2021, at 16:50, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from Jan2016 and ongoing and cardiac ablation on an unspecified date, in Feb2020 (she had her 2nd ablation in Feb2020, since then she has had intermittent episodes of atrial fibrillation. She stated prior to the second vaccine she had been in normal sinus rhythm for 8 days). Patient stated that she had a sister who had an arrhythmia problem. The patient previously, on 10Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) in the left arm, at single dose, for COVID-19 immunisation. Patient stated that she had no problem with first dose. The patient received concomitant medications (unspecified). On 04Mar2021, at 21:00, the patient experienced atrial fibrillation and on 04Mar2021 she was tired. On 05Mar2021, she developed pain in the left arm. The patient recovered from pain in arm on 05Mar2021, from tiredness on 07Mar2021, while did not recover from atrial fibrillation. The information on the lot number has been requested.
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| 66 | 2021-03-24 | muscle twitching |
Patient received her 1st dose of the Pfizer vaccine at our clinic at the time stated above. She was ...
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Patient received her 1st dose of the Pfizer vaccine at our clinic at the time stated above. She was observed for 30 minutes and sent home, per protocol. At 12N, she left the building and began heading to her car. Patient's family member brought her back inside as patient was experiencing intermittent jerking movements of her entire upper body, mainly focused on her abdomen, chest and shoulders. Vitals were obtained, Pt was AAOx4, BP 165/69, P61, R21, Pulse Ox 98%. At 1202, 911 was called as patient stated she has a lengthy history of allergies to medicines and foods. At 1206, 50 mg PO of Benadryl were given without complication. Patient stated she had discussed getting the vaccine with her allergy physician.
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| 66 | 2021-03-24 | pain in extremity |
Patient reported that she believes her vaccine was given too high in the arm. This was reported week...
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Patient reported that she believes her vaccine was given too high in the arm. This was reported weeks after receiving her second dose of the vaccine. She has experienced a lot more pain than the first dose, and was unable to do daily activities such as raising her arms above her head and sleeping on her side. She has been in contact with her doctor regarding the incident. The pain has gotten better in the last week, but some pain is still present.
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| 66 | 2021-03-24 | bell's palsy |
This is a spontaneous report from a contactable consumer. A 66-year-old female patient received her ...
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This is a spontaneous report from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 66-years-old, via an unspecified route of administration in left arm on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included high blood cholesterol and triglycerides. The patient was allergic to medications, food, or other products (unspecified). She was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. She received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a hospital. On 09Mar2021 at 15:00, the patient presented with Bell's palsy which required a doctor or other healthcare professional office/clinic visit and was treated with BETAMETASONA 5.0 mg. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
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| 66 | 2021-03-25 | weakness |
About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-23...
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About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-230pm - fever and chills, headache 5pm - fever and chills stopped Very low energy thru Friday 3/26
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| 66 | 2021-03-25 | tingling, numbness |
Patient reports had numbness and tingling around mouth and face after a few minutes fi vaccination; ...
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Patient reports had numbness and tingling around mouth and face after a few minutes fi vaccination; Resolved within minutes. Received second COVIDdose and reports numbness and tingling around lips, mouth, left arm and left leg. Numbness started 24 hours after second dose and continues at this time- 48 hours after 2nd dose.
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| 66 | 2021-03-25 | pain in extremity |
Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3...
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Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3/16 Big Toe throbbing woke me up. Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg. Throughout the next 24 hours their would be sharp pains in right ankle. Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours. Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me. It took 4 days for me to start to feel I was returning to normal function, the fifth day I felt normal. I thought this was a long time to recover from shot in comparison to what I did hear.
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| 66 | 2021-03-25 | discomfort |
Severe abdominal pain and cramping starting 12 hours after vaccine. Was severe for 12 hours and th...
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Severe abdominal pain and cramping starting 12 hours after vaccine. Was severe for 12 hours and then improved but has had continued cramping and discomfort for 10 days
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| 66 | 2021-03-25 | muscle twitching, tingling |
Tingling in hands,feet and face. Face progressed to twitching and outbreak of cold sores. I did no...
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Tingling in hands,feet and face. Face progressed to twitching and outbreak of cold sores. I did not seek medical attention.
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| 66 | 2021-03-25 | weakness |
has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore musc...
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has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore muscles, very sore at the injection site, diarrhea, nausea, headache, tender scalp These symptoms are unchanged after 24 hours (started approx 10 pm 3/24 is is now after 10pm 3/25.
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| 66 | 2021-03-25 | tingling |
palpitations 24 hours after injection lasting several hours. Today is day 3 days since injection. Th...
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palpitations 24 hours after injection lasting several hours. Today is day 3 days since injection. This morning I noticed paresthesia of lips and face and tingling of lips and tongue. Beginning at 9 am and has continued through afternoon
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| 66 | 2021-03-26 | pain in extremity |
Day after had chills, fever 101.4 neck ache, back ache both legs ache stuffy nose and cough. Took co...
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Day after had chills, fever 101.4 neck ache, back ache both legs ache stuffy nose and cough. Took covid test at pharmacy on March 24, 2021 and Test came back positive for Covid-19 on March 26,2021. Still have a low grade fever 99.2, stuffy nose, lost sense of taste and smell, ache in neck ,back, and legs head ache on and off.
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| 66 | 2021-03-26 | cold extremities, feeling cold |
I don't think this is significant, but my husband encouraged me to report it anyway. Slight headac...
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I don't think this is significant, but my husband encouraged me to report it anyway. Slight headache started evening of March 25 p.m., took 2 aspirin and was fine after. Felt O.K. next morning, March 26, but tired. Went to gym as normal, did a light workout. Came home, didn't do much. Hands felt cold - not normal for me. Went out to dinner around 4:30 p.m., came home around 6:00 p.m. and was tired and freezing, Laid down for a while with two blankets, slept a little. Got up, took my temperature - 100.3. Took 2 aspirin and went to bed. Today, March 27, got up around 9:00 a.m., feeling normal! Temperature is 98.6.
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| 66 | 2021-03-26 | weakness |
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se...
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high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
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| 66 | 2021-03-27 | cold sweat, weakness |
Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began ...
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Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began soon after, and then vomiting. Both projectile (I know, eww). I experienced this every 30-60 minutes for about 7 hours. Then the nausea subsided, and the episodes of diarrhea began to happen at longer intervals. I also experienced cold sweats and the next day my body temperature was reading low (96.4 at one point). My brain fog and weakness were probably the result of dehydration.
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| 66 | 2021-03-27 | flushing |
Entire body itching including face, lips, upper palate , throat and tongue. Skin slightly flushed b...
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Entire body itching including face, lips, upper palate , throat and tongue. Skin slightly flushed but NOT a raised rash. Took Benadryl within 15 minutes and slept for 5 hours. 24hours later body still feels hyper sensitive /itchy but tongue and lips not so much.
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| 66 | 2021-03-28 | pain in extremity |
Extreme nerve -like pain up and down left arm, elbow, wrist, hand, fingers, shoulder, upper left bac...
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Extreme nerve -like pain up and down left arm, elbow, wrist, hand, fingers, shoulder, upper left back. Pain started a few minutes after injection. Pain continues. It has been 4 days.
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| 66 | 2021-03-28 | facial paralysis, one side paralysis, slurring |
Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria ...
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Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning. Patient found to have an ischemic stroke and ultimately admitted to hospice. Patient expired on 3/10/2021.
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| 66 | 2021-03-28 | speech disorder, weakness, pain in extremity |
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous...
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feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
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| 66 | 2021-03-28 | numbness and pain in extremities, weakness, tingling |
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;...
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peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-30 | tingling |
Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders an...
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Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
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| 66 | 2021-03-30 | muscle spasms |
I am having liver and kidney issue which could be reason for my ankles are swelling; I am having liv...
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I am having liver and kidney issue which could be reason for my ankles are swelling; I am having liver and kidney issue which could be reason for my ankles are swelling; Muscle cramps in right calf; My feet are swelling and it has been swelling for about 4 days now; Swelling in my ankles; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number EP8982; Expiration Date: 31JMay2021) via unspecified route of administration on 21Jan2021 as single dose for COVID-19 immunisation. Medical history included lung neoplasm malignant, asthma, neoplasm malignant. Concomitant medication included ALECENSA taken for lung neoplasm malignant, SPIRIVA, fluticasone propionate, ADVAIR, DUPIXENT and XARELTO taken for neoplasm malignant. The patient experienced swelling in my ankles (joint swelling) on 26Jan2021, muscle cramps in right calf (muscle spasmson 24Mar2021, my feet are swelling and it has been swelling for about 4 days now (peripheral swelling) on 26Jan2021, i am having liver and kidney issue which could be reason for my ankles are swelling (liver disorder , i am having liver and kidney issue which could be reason for my ankles are swelling (renal disorder). The patient underwent on Jan2021 lab tests and procedures which included blood test: unknown results, On Jan2021 computerised tomogram: unknown results. The outcome of the events are unknown. Follow up is completed. No further information is expected.
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| 66 | 2021-03-30 | weakness |
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fev...
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I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever. On Saturday I was better but still weak and that is when cellulitis started in my left leg. On March 7, 2021, I was seen in the ER. I was given a shot and antibiotics and told to return if not better. So on Monday, March 8, I returned to ER and then was admitted to the hospital. I was allowed to go home on Saturday, March 13. Since then I had two sores to develop on my left leg. I had to have wound surgery on them on March 25. I am a lot better but still not completely well.
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| 66 | 2021-03-30 | inability to speak, seizure |
Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed ...
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Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed for approximately 2 minutes. Code called and patient sent to ER via 911 No history of Seizures she has ongoing seizures. there is a significant decline in her mental status. She is not speaking. She has to be fed. She is not walking.. She is scheduled to see a neurologist in June 2021.
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| 66 | 2021-03-30 | tingling |
body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a sp...
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body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
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| 66 | 2021-03-30 | numbness and pain in extremities |
drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart...
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drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart beat; no appetite; exacerbation of existing neuropathy; Palpitations; being lightheaded; sweating; burning mouth syndrome; burning mouth syndrome; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; Some of my reactions look like an allergic reaction; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 66-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3302, expiry date not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 at a single dose for COVID-19 immunisation. Medical history included neuropathy from 2006 and ongoing, since she had chemotherapy in 2006 for breast cancer in 2006 and burning mouth syndrome. The patient had no covid prior vaccination. The patient had no known allergies. The patient had other medications in two weeks which included unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient previously took doxycycline from 2010 to an unknown date for Lyme's diseaseand experienced burning mouth syndrome. On 11Mar2021 at 02:00 PM, patient had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. These symptoms still continue. Patient stated that people were talking about the second dose being worse. Patient stated that some of the reactions in Mar2021 look like an allergic reaction. They (HCP) only have cautioned the patient about difficulty breathing in Mar2021. They were saying there wasn't anything they can do for it. Patient asked how long the side effects will last and how to go about changing the appointment. If they are going to continue, patient was very concerned about following up with the second shot and asked if they can have that second shot be postponed until patient was not experiencing these side effects to the effect that she was. She completed the self-reporting on Monday (15Mar2021), but because her side effects were not going away she wanted to reach out to someone. She has reached out to her practitioner and had an appointment yesterday. Doctors didn't really know because it was all very new. She had the first vaccination shot on 11Mar2021, almost a week ago. In the 15 minutes that she waited afterwards she definitely experienced palpitations and a feeling of lightheadedness. She has an underlying condition of burning and pain called neuropathy. She has had neuropathy since she had chemotherapy in 2006 for breast cancer. This exacerbated that. She had been very concerned about that prior. Everyone said and the CDC recommends even with neuropathy to go ahead with the vaccine. It also triggered another underlying condition. She had a reaction to a course of Doxycycline in 2010 for Lyme's disease that caused burning mouth syndrome. Both of these things were really acute now, the neuropathy and burning mouth syndrome. Monday (15Mar2021) was a particularly bad day because the symptoms of an allergy which were swelling of the face and throat, fast heart beat, and dizziness were with the burning mouth syndrome. She didn't have difficulty breathing. It was the nerve endings of the tongue that go all the way to the back of her throat and gave the sensation of the whole mouth being involved. Monday was difficult. It was 8 hours of an acute episode then it eased off a little that evening. She had no appetite on Monday and barely ate anything. Yesterday was ok and much better although she was being triggered by environmental thing such as food and toothpaste. Things she normally uses were setting it off. She had an acute reaction this morning to a protein shake she has had every day for 14 years. The reaction this morning, 17Mar2021, was a drop in blood pressure and palpitations. It passed. She has been documenting this and made her provider aware of what she was experiencing. She was participating in the V-Safe through the CDC that checks up on her everyday and asks about symptoms. She didn't know if she was supposed to report this to the vaccine adverse event system or not. Obviously, she didn't want to get COVID. She was struggling with the recommendation to get second shot because she was extremely concerned. She wanted to know how long will the side effects will last and if she can postpone getting the second shot until she gets reasonably well. No practitioner can recommend whether to do it or not to do it. She reported this information online to Pfizer on 15Mar2021. She provided the lot number when she reported it online. The patient was not tested for COVID post vaccination. No treatments received from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The patient recovered with lasting effects from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The outcome of the other reported events was unknown.
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| 66 | 2021-03-30 | feeling jittery |
having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ri...
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having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ridiculous, and the fatigue knocked her off her feet; feeling jittery and irritable; feeling jittery and irritable; This is a spontaneous report from a contactable consumer. This 66-Year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (Pfizer-Biontech COVID 19 vaccine, Lot number EN6200) at single dose for COVID-19 immunisation on 26-FEB-2021 at 11:30. Relevant history was unknown. The patient previously received Pfizer-Biontech COVID 19 vaccine on 05Feb2021 for COVID-19 immunisation. Past drug included mild blood pressure medication. Relevant concomitant drug was unknown. The patient has fatigue, she kept getting choked when drinking water, feeling jittery and irritable since 28Feb2021. She said the fatigue was ridiculous, and the fatigue knocked her off her feet. The patient asked if there was something she could do for the fatigue she was experiencing. This reaction was really not good. She was having problems swallowing. She said the swallowing problem started at the same time as the fatigue on Sunday, 28Feb2021. No treatment was received for the events. The outcome of event having problems swallowing was not resolved. The outcome of other events was unknown.
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| 66 | 2021-03-30 | weakness |
she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at a...
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she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at all; she had achiness; she knewshe had a high fever; Sweating; unbelievable fatigue/she was really tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in the right arm, on 04Mar2021 16:30 (at the age of 66 years old) at a single dose for covid-19 immunisation. This was administered as a pharmacy/drug store. Medical history included asthma for a very long time and overweight. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular route in the right arm on 30Jan2021 (at the age of 66 years old) at a single dose for covid-19 immunization. She did not have any problems with the first dose. The patient had no additional vaccines administered on same date of the Pfizer vaccine. There were no prior vaccinations within four weeks. The patient reported she was really tired after receiving her second COVID-19 Vaccine on 04Mar2021, saying she slept unbelievably good the night of 04Mar2021. On 05Mar2021, the patient experienced she had instantly come down with unbelievable fatigue, she wanted to sleep a lot, she had no energy at all (if she tried to do something, she would have to lay down afterwards), she had achiness, she knew she had a high fever, even though she did not check her temperature, she knew her fever was high because she was sweating but it was nothing she was worried about. She stated she was concerned about the unbelievable fatigue she was experiencing. Her tiredness had improved some, and her achiness resolved about the second day (unspecified date in Mar2021). She stated her fever went away in two days (unspecified date in Mar2021). Reported the pharmacist told her to take TYLENOL after the second COVID-19 Vaccine. She bought a bottle of TYLENOL while she was at the drug store, but she decided not to use the TYLENOL for the symptoms. Reported she didn't take her PROLIA injection in Jan2021 because she didn't want it to interfere with her upcoming COVID-19 Vaccine. She said she self-administered her PROLIA injections, and hadn't restarted it at this time. All the events did not require a visit to emergency room or physician office. Outcome of the events fatigue, she wanted to sleep a lot, she had no energy at all was recovering. Outcome of the events achiness, fever and sweating was recovered on unspecified date in Mar2021. Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296202 same reporter, drug and events, different patient
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| 66 | 2021-03-31 | bell's palsy, pain in extremity |
Bell's palsy; Sore Arm; This is a spontaneous report from contactable consumers (one is the patient)...
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Bell's palsy; Sore Arm; This is a spontaneous report from contactable consumers (one is the patient). A 66-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose, via an unspecified route of administration, administered in Arm Right on 03Mar2021 11:40 am (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a hospital. Medical history included Type 2 diabetes mellitus: Diagnosed one year ago; Gastrooesophageal reflux disease (GERD) Diagnosed 2 years ago; Hashimoto's disease Diagnosed 5 or more years ago; High cholesterol and blood pressure abnormal (reported as Blood pressure); all from an unknown date and unknown if ongoing. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks, also no Family Medical History Relevant to the adverse events. Concomitant medications included metformin 500 mg once a day by mouth taken for diabetes (reputed Has been taking that about a year); pravastatin sodium (PRAVACOL) 40 mg once a day by mouth taken for High cholesterol; levothyroxine sodium (SYNTHROID) 50 mcg once daily by mouth taken for an unspecified indication; omeprazole 20 mg once a day by mouth taken for an unspecified indication; and losartan 50 mg once a day by mouth taken for blood pressure; all start and stop date were not reported. It was reported that the patient is calling about the COVID Pfizer vaccine shot. The patient took the first dose of the shot on Wednesday 03Mar2021. The patient now has been diagnosed with Bell's Palsy and she believes that it is from the shot. The patient's speech is impaired because of the bells palsy. The only thing the patient had was a sore right arm on 04Mar2021. Then on 10Mar2021 the left side of her neck started to really hurt and behind her ear, it was severe pain, frequently she would get a jolt of pain on top of the existing pain. The patient had this pain 10Mar2021, 11Mar2021, 12Mar2021, and by Saturday 13Mar2021 her face started to distort, now she couldn't close her eye, her lips were numb, and her speech was interfered. Monday (15Mar2021) morning the patient was seen by her primary care provider and her doctor told her it was Bell's Palsy. Blood was drawn at that time, but the patient doesn't have the results yet. The patient was given prednisone and an anti-viral which after she took them it helped with the pain significantly. The patient's face still has the paralysis on the left side of her face. No other parts of her body were affected other than a sore arm at the site on the right side, which was not a big deal. It was reported that the patient is taking COVID vaccine as she heard she should get it and her husband had the shots and was fine. The patient mentions that her husband had one bad day after the vaccines but he was fine, so she decided to get it. The patient wanted to know, she is going to follow up with her primary care provider on 22Mar2021 but she was scheduled for her second Pfizer shot on 24Mar2021, should she get the second dose. The patient read that 40,0000 people were given the vaccine and 4 people had bell's palsy and because of that they discounted it as a side effect, and the placebo group did not develop this. It was noted that the patient did not required emergency room visit but to the Physician's office (Primary Care Provider). The patient does not have the results of her blood work back yet. The outcome of the event a sore right arm was recovered on 06Mar2021; for the other event was not recovered. The relatedness of drug to reaction(s)/event(s) for the event Bell's palsy was reported to be related.
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| 66 | 2021-04-01 | seizure, feeling hot |
Had 2 seizures; Had 2 seizures; Tongue hurts; it was an allergic reaction; Patient reported that nex...
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Had 2 seizures; Had 2 seizures; Tongue hurts; it was an allergic reaction; Patient reported that next the day her arm was so hot that she could have roasted a weenie over her arm and it was very swollen; Patient reported that next the day her arm was so hot; got shingles again after receiving the vaccination; got shingles again after receiving the vaccination; This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6202), via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 (at the age of 66-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a health clinic. The vaccine was not administered at a facility. The patient had no additional administered vaccines. No prior vaccinations (within 4 weeks). Medical history included ongoing seizures from 1982 (began shortly after she had the surgery for her brain aneurysm (in 1982 to 1982). The patient had not had any seizure activity for 20 years before the seizures that occurred on 13Mar2021. Sometimes electrical activity in the brain hits the metal clamp used to treat the brain aneurysm and that triggers the seizures); migraines (suffered from migraines when she was younger but hasn't had one in umpteen years. The patient gets tension headaches like most people but not very often); shingles (patient had shingles three times. Patient's first case of shingles was in the early 1990's and that patient had recurrences in the mid 1990's and the early 2000's. The first incidence was the worst and that the second and third occurrences weren't nearly as bad as the first); blood pressure high; ongoing cholesterol; ongoing headache (tension headaches) and was adopted. Family history included migraines with grandkids, a couple of them had migraines and had MRI's she'd had a sister that was 6 years older than her that had died of a brain aneurysm. Concomitant medications included levetiracetam (KEPPRA) for seizures from an unspecified date (in the late 90's) to an unspecified date then from Mar2021 and ongoing; nadolol for headache from 2001 and ongoing; lovastatin for cholesterol from an unspecified date (been on it for a long time) and ongoing and on a low dose of medication for high blood. The patient had the Pfizer vaccine first shot on Friday (12Mar2021). The husband stated his wife (patient) had a possible side effect to the vaccine shot and was concerned with getting the second dose of Pfizer's COVID vaccine. She had 2 seizures the next morning after the shot (on 13Mar2021) which she hasn't had in 20 years. The patient experienced her first seizure about 11:00 on 13Mar2021. It took the patient about 45 minutes to come out of the first one completely, until she was conscious again. The second seizure occurred about 13:00 on 13Mar2021, about an hour and a half after the patient recovered from the first seizure. fter the second seizure, the fire department was called and she was transported to the Emergency Room. The doctor told the husband that it was up to them if they wanted to receive the second dose. The husband stated, "I know there is something out there that I heard about where you can disqualify yourself from getting the vaccine for medical reasons." Also on 13Mar2021, the patient's tongue hurts in the Emergency Room, no one was willing to give her a new tongue after she bit it. The patient's tongue was what hurt's the most, but that it was slowly healing. The patient seemed to be fine since Saturday. he patient's father was really persistent about them getting the Covid-19 vaccinations. A CT scan and blood work were performed while she was in the Emergency Room on 13Mar2021 and reported that everything was fine. The patient went to the emergency room on 13Mar2021 and physician office on 17Mar2021 as a result of the seizure activity on 13Mar2021. On 17Mar2021, the patient's blood pressure was 130/82 with blood work with result of everything was fine. The patient went to her physician on 17Mar2021 due to concern about getting the second dose of the Covid-19 vaccine. When asked about prior vaccinations within 4 weeks of the Covid-19 vaccine, the patient stated that she didn't want to get the first dose of the Covid-19 vaccine because she's never even had the flu shot. The patient stated that back in 1977 when they first came out with the flu shot, she was unable to receive the vaccine as she was pregnant and she has never gotten the flu. The patient reported that she was unable to get MRIs due to the metal clamp in her. Patient reported that the clamp in her head was metal, not surgical metal, and that she has to be very careful because getting an MRI could kill her. The patient reported that next the day (in Mar2021) her arm was so hot that she could have roasted a weenie over her arm and it was very swollen. The patient reported that she went to urgent care and was told that it was an allergic reaction. The patient also reported that she got shingles again after receiving the vaccination. The husband considered the case as non-serious. The patient recovered from seizure with associated disease recurrence on 13Mar2021; for tongue pain was recovering while for the remaining events was unknown.
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| 66 | 2021-04-01 | inability to speak |
Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous re...
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Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-04-01 | tingling, numbness, burning sensation |
The only immediate reaction to the vaccine was soreness in my arm. On March 11, I woke at 3:30 AM an...
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The only immediate reaction to the vaccine was soreness in my arm. On March 11, I woke at 3:30 AM and had almost total hearing loss in my right ear along with some unsteadiness. I have also experienced unusual neurological symptoms like burning, tingling and numbness in my right foot, leg, hand and face. My second vaccine was delayed because I was taking steroids to help with hearing loss. I had my second shot on March 31 with no side effects to date.
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| 66 | 2021-04-01 | bell's palsy, numbness |
short of breath; fear and anxiety or from the vaccine; fever blisters; fear and anxiety or from the ...
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short of breath; fear and anxiety or from the vaccine; fever blisters; fear and anxiety or from the vaccine; like bells palsy; numbness of the right side of her face from her jaw to her ear and up to her right eye; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration, on 26Feb2021 (received at the age of 66-years-old), at a single dose for COVID-19 immunization. Medical history included cold sores, 2 knee surgeries, and ADD (Attention deficit hyperactivity disorder) from an unspecified date and ongoing (diagnosed at 30-years-old). Concomitant medications included methylphenidate hydrochloride (RITALIN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and other regular medication. The patient received first dose of Pfizer BioNTech vaccine and developed numbness of the right side of her face from her jaw to her ear and up to her right eye on 26Feb2021. It felt like she had received a lidocaine injection. Her doctor said this can happen with RNA vaccines, affect the 7th cranial nerve and develop Bell's Palsy. She was prescribed Valacyclovir 1mg and has taken it for 3 days. She wants to know what the other Bell's Palsy cases were like. She wants to know what their treatments were. Her doctor said it was okay to receive her second dose at 8am on 20Mar2021 but she wants to do her due diligence and see if there is a case report or study on these patients that developed this side effect. The patient further explained that she had her first dose on 26Feb2021 and was she was there for the 15 minutes for observation. On her way home, the right side of her mouth and the right side of her nostril were numb like Novocaine that you get at the dentist. She said that the numbness traveled up the right side of her jaw to her ear and then over to her right eye. When she got home, she told her daughter and she said that she thought it was because she volunteered all day and was worn out and anxious (26Feb2021). She said that she slammed water and ate crackers and after about a 1.5 hours she started to feel better. She said that she then she called her physician and the doctor told her that it was flaring the nerve root like bells palsy and that it is a RNA Virus. She said that she was placed on some medication for it, but was wondering if she should get the second dose of the vaccine. She said that the doctor asked her if she had previously had cold sores and she said yes. The caller said that her doctor said that it is exactly what that is. The patient stated that she was also short of breath on an unspecified date, but thought it was from fear and anxiousness. She does not know if it was from fear and anxiety or from the vaccine. She said that the doctor told her to take the medication 3 days before and 3 days after her second dose. She clarified that the doctor put her on Valacyclovir HCl 1Gm tablets 1 a day. She said that she broke out with fever blisters on 02Mar2021. She really did not think anything of it until speaking with friends in the medical field and they told her to follow up with this. She added that the fever blisters are healing and only a tiny bit left. It is at the scab and end of healing. Outcome of numbness of the right side of her face from her jaw to her ear and up to her right eye was recovered on 26Feb2021. Outcome of fever blisters was recovering. Outcome of other events was unknown.
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| 66 | 2021-04-05 | nerve pain |
This greatly accelerated symptoms from after first shot and sent me to ER next morning where was kep...
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This greatly accelerated symptoms from after first shot and sent me to ER next morning where was kept on pain med IV for 4 days and received MRI. Discharged home with pain meds, muscle relaxers, and nerve pain med.
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| 66 | 2021-04-06 | pain in extremity, muscle twitching |
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau...
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After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days.
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| 66 | 2021-04-06 | pain in extremity, muscle twitching |
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau...
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After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days. Adverse event described in on Continuation Page.
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| 66 | 2021-04-06 | numbness and pain in extremities |
developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from...
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developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
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| 66 | 2021-04-15 | numbness |
Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 a...
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Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 am. Continued to 4:30 am on April 10. Slight elevated temperature at 99.1 . On morning of April 11 couldn't put pressure on right side, leg and arm, facial numbness. Went to er and they said I was having a stoke, transferred to hospital. MRI done verified Stroke with blood clot to Left thalamus Sent home and will be receiving PT and OT.
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| 66 | 2021-04-16 | one side paralysis, slurring |
Hospitalized with a TIA (transischemic attack) slurred speach, cognitive abilities effected, left-si...
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Hospitalized with a TIA (transischemic attack) slurred speach, cognitive abilities effected, left-sided weakness
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| 66 | 2021-04-17 | burning sensation, bell's palsy, feeling hot, numbness |
Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning s...
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Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
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| 66 | 2021-04-17 | tingling, pain in extremity |
Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurt...
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Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area. It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking. She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.
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| 66 | 2021-04-17 | pain in extremity |
her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extr...
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her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered. Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related. Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-04-17 | seizure |
seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is ...
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seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 66 | 2021-04-24 | pain in extremity |
swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ ...
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swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ achy pain; She couldn't straighten it out or bend it all the way down, it was like it was locked; joint went stiff and the pain; joint went stiff and the pain; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration at left upper arm 10Mar2021 at 12:30 (66-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included thyroid, and "had stem cells put in her hip". Concomitant medications included ongoing thyroid (ARMOUR THYROID) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) via an unspecified route of administration at left upper arm 17Feb2021 at 14:00 (65-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient previously received the second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for shingles and felt like we were getting the flu and the next morning was fine. Patient states she had stem cells put in her hip and was (medical office name) for an x-ray to see how it's doing. She showed a nurse practitioner her hand and nurse practitioner said patient needs to report that. Patient states it swells right under her finger, swelling under her middle and ring finger. The joint went stiff and the pain. She can't bend her fingers, it is mostly her ring finger. She couldn't straighten it out or bend it all the way down, it was like it was locked. Following her second vaccine dose she has had pain in the center of the palms of her hands and bottom of her feet. The pain is inconsistent as it comes and goes. The feet pain come and go not bad like the hands. The middle of the palm pain comes and goes and the joint on 1 finger never did get better, it is worse at night and a teeny bit better in the morning. She felt pain in 1 of her feet for a moment yesterday and not continuous like her hand. The left hand is not swelling, the center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like, it is an achy pain. States she kept telling her husband she has pain in the center of her hands and on the bottoms of her feet and feels like she is about to have a break out and didn't. Patient states it has been a month since she had the 2nd vaccine. States the symptoms all started within 24 hours of the 2nd vaccine. On 07Apr2021, nurse practitioner put a lubricant injection (name unknown) into her hand where the swelling was. Patient was told it was a lubricant that might help, and it has helped some. It is moving a little better today after the injection but she still has pain. Adverse events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the event "swells right under her finger" and included lubricant injection. The outcome of swells right under her finger, joint stiffness, and joint lock was recovering; other events were not recovered. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-26 | pain in extremity |
Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong head...
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Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong headaches were common & continue; She had lost a week of her life trying to keep warm; This is a spontaneous report received from a contactable other healthcare professional (patient). A 66-year-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in left arm on 10Feb2021 at 09:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization in Public Health Clinic/Veterans Administration facility. Medical history included allergic to dust, mold, mildew, hay, cat & rabbit hair. Concomitant medications included atorvastatin, cetirizine, amlodipine, all received in two weeks. No other vaccines received in four weeks. The patient previously took moxifloxacin hydrochloride (AVALOX) and had allergies (Bayer wide spectrum antibiotic). The patient had not been tested for COVID prior vaccination. It was reported that 10 hours after receiving the vaccine Temperature dropped to 94.3 on 10Feb2021 at 08:00 PM. For next 8 days it has varied as sub-normal from 95 to 97.6, mostly ranging from 95.4 to 96.5. Had a very sore arm for two days with swelling in gland under the arm. Strong headaches were common & continue. Eight days out that swelling is still going down. The doctor visit was a waste of time & money. They knew little & couldn't offer any suggestions. She was afraid to get the second shot because the doctor did tell her side effects would be worse with that one. She had lost a week of her life trying to keep warm. Her temperature did go up to normal & past on day 8 after she was in a very hot vehicle for 1/2 hr. Events resulted in visit to Doctor or other healthcare professional office/clinic. No treatment received for events. The patient had not been tested for COVID post vaccination. The outcome of events was recovering. Information on lot/batch number has been requested.
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| 66 | 2021-04-26 | pain in extremity |
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li...
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nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-30 | flushing |
flushed hot face; sweaty head; BP 160/90; This is a spontaneous report from a contactable consumer, ...
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flushed hot face; sweaty head; BP 160/90; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received the second dose (Lot Number: ER8732) of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included sleep apnea, asthma, obesity, anxiety (antidepressants for 35 years), and allergy to lemon, lime, green peppers, mushrooms, walnuts. Concomitant medications included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA); tiotropium bromide (SPIRIVA); albuterol [salbutamol] (MANUFACTURER UNKNOWN); duloxetine hydrochloride (CYMBALTA); vitamin d3 (MANUFACTURER UNKNOWN); vitamin c [ascorbic acid] (MANUFACTURER UNKNOWN). The patient previously received furosemide (MANUFACTURER UNKNOWN) and theophylline (MANUFACTURER UNKNOWN) and experienced drug allergy to both on unspecified dates. The patient previously received the first dose of the bnt162b2 (Lot Number: EN6206) on 09Mar2021 13:00 at a single dose in the left arm at 66 years of age for covid-19 immunisation. There were no other vaccinations within 4 weeks prior to vaccination with bnt162b2. There was no covid-19 prior to or post vaccination with bnt162b2. On 30Mar2021 at 14:00, the patient experienced 30 minutes after shot, while still sitting in the post-shot waiting area: flushed hot face, sweaty head, BP 160/90, which were non-serious. BP was 130/72 just before going to the get the shot on 30Mar2021. There was no therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered after about 30 minutes on an unknown date. The patient fully recovered within an hour. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-30 | pain in extremity, difficulty speaking |
sinus issues; stuffy nose; cough; hoarseness; soreness in both arms; This is a spontaneous report fr...
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sinus issues; stuffy nose; cough; hoarseness; soreness in both arms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 08Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Vaccination facility type was Clinic. Medical history included Parkinson's from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 via intramuscular administration administered in left arm on 18Mar2021 for COVID-19 immunisation and experienced sore arm, and took a Flu shot probably 25 years ago. The patient experienced cough on 09Apr2021 with outcome of recovering, hoarseness on 09Apr2021 with outcome of recovering, sinus issues on 09Apr2021 with outcome of recovering, soreness in both arms on 08Apr2021 with outcome of recovering, stuffy nose on 09Apr2021 with outcome of recovering. Patient had sinus drainage on 09Apr2021. AEs did not require a visit to Emergency Room and Physician Office. Clincial course reported as follow: Patient stated that it may be obvious by the sound of her voice that after the second dose of COVID vaccine on 08Apr2021, by the time patient woke up on 09Apr2021, she had developed a cough. The cough was getting better but her voice was very hoarse, and has also had sinus issues with it, stuffy nose and sinus drainage. Patient stated that the cough was worse last night and her husband was concerned because she had Parkinson's. Patient believed her height was 4'10" or 4'11" and her weight 80-85 pounds right now, she had Parkinson's and for that reason she carried a low weight. Patient stated that with the second COVID vaccine, it was weird because she could feel the pain in her left arm even though she got the dose of COVID vaccine in the right arm so both arms hurt after the second dose. The hoarseness, sinus issues, cough all started 09Apr2021 in the morning when patient woke up. She stated that those symptoms were improving. The pain in both arms after second dose was improved, the pain started on 08Apr2021 and that the pain started right when she was giving me the vaccine. Patient stated that after a flu shot that was probably 25 years ago. Patient stated that within 3 minutes of getting that flu shot her left sinus blocked up and stayed blocked up for 3 weeks (no treatment). When she told her doctor, the doctor recommended not getting any other flu shots. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 66 | 2021-04-30 | unresponsive to stimuli |
unresponsive; This is a spontaneous report from a contactable healthcare professional (patient). A 6...
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unresponsive; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 12:45 (Lot Number: EW0158) as SINGLE DOSE for COVID-19 immunization. Medical history included melanoma brain cancer from an unknown date and unknown if ongoing. Concomitant medications included hydrocortisone, calcium carbonate, colecalciferol and meso zeaxanthin, xantofyl, zeaxanthin (MACUHEALTH WITH LMZ3); all taken for an unspecified indication, start and stop date were not reported. The patient previously had first dose of BNT162B2 (lot number: ER2613) on 23Mar2021 12:15 PM in the right arm for COVID-19 immunisation at 66 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient as not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive on 14Apr2021 01:00 PM. The patient was admitted to the hospital and was released 2 days later. Many tests were performed including a Spinel Tap, MRI (brain - that is where my melanoma cancel was located), and a full panel of lab work on unspecified date. All tests responded normal. The patient was in the hospital for 2 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was given to the patient such as fluids, hydrocortisone and antibiotics. The outcome of the event was recovering. Information on about lot/batch number has been requested.; Sender's Comments: Based on the information provided, this patient with a medical history relevant for melanoma brain cancer from an unknown date and ongoing. It was noted that the day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive. Although the reported event could be possibly related to intercurrent melanoma brain cancer, due to the plausible temporal association, a possible contributory role of the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-05-04 | difficulty speaking, speech disorder |
Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat ...
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Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel. Information about lot/batch number has been requested.
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| 66 | 2021-05-06 | paralysis, pain in extremity |
Significant weight loss; Chronic back pain; terrible pain in the back; Osteolysis; Terrible pain in ...
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Significant weight loss; Chronic back pain; terrible pain in the back; Osteolysis; Terrible pain in her extremities; It was her first dose and she was afraid to get the second one now; patient was supposed to get her second one last week and she didn't; Paralyzed from her neck down to her arm, legs, and everything; weakness in extremities; could not move; Received BNT162B2 via subcutaneous route; This is a spontaneous report from a contactable nurse (patient who is a retired nurse who did anesthesia). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), subcutaneous in right deltoid of the upper arm, on 09Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included pain, use of medication to help with sleep, gastroesophageal reflux disease (GERD), and thyroid. The patient's concomitant medications included levothyroxine for thyroid, pantoprazole sodium sesquihydrate (PROTONIX) for GERD, trazodone to help with sleep, zolpidem tartrate (AMBIEN) to help with sleep, morphine (extended relief) for pain, and morphine sulfate (immediate relief) for pain. They also gave the patient diazepam (VALIUM) if she needs to take it but she did plan; she didn't take it. The patient just didn't take diazepam and then pain management doctor put her on morphine extended release. Then, morphine sulphate immediate relief, so she can take up to 4 for day and she was not using now. The COVID-19 vaccine was administered in a pharmacy. The patient would like to report a reaction that she received that she had approximately for an hour and a half, that basically started in an hour after the injection. The patient's first COVID-19 shot was given by Pfizer on 09Mar2021 and what happens in next hour was she became totally paralyzed from her neck down to her arm, legs, and everything. It was approximately about 30 minutes after the shot that she began to notice some weakness in extremities (also reported as eternities) and then they got home an hour later, and her husband left the patient then she got to know she could not move. The patient can breathe, and she was totally conscious, but she could not move, could not pull herself along the floor, could not pull from the sofa, could not move her knee, and could not move her body. So, the patient thought maybe she should report this. On an unspecified date, the patient had significant weight loss. The patient was eating but she was rapidly losing. The patient didn't have COVID-19; she had been tested negative, so she didn't have COVID-19. The patient was tested 4 times for her to be around her grandchildren and make sure everything is okay. The patient had been tested against COVID-19 because of her grandchildren. The patient tried to take them, and she just now received the paper it was negative. So, it was her third one to try to watch her grandchildren because they were infant, and all test results were negative. It was also reported that the patient had no other problem, just the pain clarified as chronic back pain since an unspecified date. The patient checked this as persistent for chronic back pain; it is positive, definitely it's totally osteolysis on an unspecified date. Treatment was received for all events (unspecified medications). The patient went to her primary healthcare doctor as a result of the events and he said it was no big deal and she told him that she disagrees with that. Trazodone was added to zolpidem tartrate to help w with the sleep because she had terrible pain in the back (right here) and her extremities after this incident (unspecified date). It was her first dose and she was afraid to get the second one now. The patient was supposed to get her second one last week and she didn't. So, they told her to come back in 3 weeks or 4 weeks. The patient underwent laboratory test back in December (unspecified year). The patient recovered from "Paralyzed from her neck down to her arm, legs, and everything; weakness in extremities; could not move" on 09Mar2021. The patient had not recovered from "Chronic back pain; terrible pain in the back". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: A contributory role of BNT162B2 to event paralyzed from her neck down to her arm, legs, and everything cannot be excluded based on close temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-05-12 | pain in extremity |
pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; ...
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pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; pain in her chest whenever she would take a deep breathe; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318, Expiration date unknown) at 10 AM via an unspecified route of administration on 04Feb2021 at 10:00 as single for covid-19 immunization. Medical history included ongoing Psoriatic arthritis and first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EL8982, Expiration date unknown) via an unspecified route of administration on 14Jan2021 for Covid-19 immunization and minimally sore arm. Concomitant medication included methotrexate (Injection) at 0.4 mL, weekly taken for Psoriatic arthritis. It was reported that, pain in her chest whenever she would take a deep breathe and described the symptoms as pleurisy symptoms on an unspecified date in 2021. Stated that the pain has "definitely subsided and it was gone within a week. Reports that her oxygen saturations were lower than normal, and stayed around 94%. With her second injection she had what she thought was some interesting side effects from the vaccine. She says the first one she got she only had a minimally sore arm, she got that first one on the 14Jan2021 and then got the second vaccine on 04Feb2021 and the first 24 hours her arm was really sore on an unspecified date in 2021, but she thought that was nothing to worry about. She got the second dose at 10 am and the next day after 10 AM at about 1 or 2PM she noticed that it was sore for her to take a breath and she thought hmm okay. That night she had a low grade fever which she expected and she took Tylenol. On an unspecified date in 2021, the next morning she woke up Saturday at 5 AM in severe she pain couldn't turn over, she couldn't take a deep breath, she had fever of 102, she managed to get up and she took Tylenol and she had to sit in a chair, she couldn't take a deep breath. She was not short of breath, she just couldn't expand her lungs and she went to a clinic at about 3PM because she was scared she had a pulmonary embolism, they did a chest x-ray and didn't see anything, and they said it sounds like pleurisy, she has never had that in her life ever and they just gave Toradol and said if it gets worse come back the next day or if it does not go away come back Monday. She says it did not end up getting better she was the same way the next morning. Her O2 sats were staying around 94 which was not bad but for a healthy person they should be a little but higher than that, but she couldn't take a deep breath. She says that Monday she thought maybe she got Corona and didn't know it so she went back to the Clinic and asked for a test and she tested negative for the corona virus and they just said they did not feel like it was vaccine related. They sent her home and did not do anything else. It took her until Friday of the week after the vaccine. She says she got the vaccine on a Thursday and on Friday she started feeling bad and it took until the following Friday and Saturday to be fever free and feeling like a human being. She has been on hold for 2 hours so she can answer some questions. She confirm it was the second dose that she was calling about. She got the second dose 04Feb2021 and she had minimal slight soreness when she took a deep breath starting the next day. She says it did not present it self as sever until 5 AM the next morning after she had been asleep all night. She says initially it was pain in both sides of her chest but it wound up setting on the right side, the right lung, she says she keeps saying lung but it she would say right chest. She takes Methotrexate injection once per week for psoriatic arthritis and she contacted her rheumatologist and he okayed her to get the vaccine. She says it was a small dose. It comes in bottle of 50 mg per 2ml and she only takes 0.4 ml once weekly. She has been on it for about a year and half. She would says it was medically significant because she doesn't normally get ill with anything hardly. She does not even go to the doctor but once per year to get a check up. She asks has anyone else reported symptoms like this, pleurisy like symptoms. She asks if it was not long she would be interested to see. The outcome of the events was unknown and Causality was reported as related. Follow-up activities completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pleurisy and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 66 | 2021-05-13 | bell's palsy |
fever blisters; ear ache; stress; 2nd dose of the Pfizer Covid vaccine on 02Mar2021 and on 24Apr2021...
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fever blisters; ear ache; stress; 2nd dose of the Pfizer Covid vaccine on 02Mar2021 and on 24Apr2021 she went to the emergency room with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A currently 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 02Mar2021 16:00 (also reported as 16:30) (Batch/Lot Number: Unknown) as 2nd dose, single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included bell's palsy from 07Jan2015; and an unspecified risk factor. The patient had no concomitant medications. The patient did not have any prior vaccinations within 4 weeks. The patient did not have family medical history that was relevant to adverse events and no relevant tests were done. The patient previously took shingles vaccine (Merck) that started with the letter 'Z' and had Bell's Palsy in Jan2015 which was exactly 6 weeks after she got a shingles vaccine; tetanus vaccines 10 years ago as a booster and experienced severe swelling on her arm, swelling in her body; Quadravalent flu vaccine and never had a reaction to the flu vaccines; and the first dose of BNT162B2 (reported as 'Pfizer COVID') for COVID-19 immunisation on 02Feb2021 in the left arm. On 24Apr2021, the patient experienced bell's palsy. On unspecified dates, the patient experienced fever blisters, ear ache and stress. The events were reported as follows: Her HCP should have the information on the shingles vaccine she got in 2015. When she had bell's palsy the 1st time in 2015, she had to go to the hospital for a day and a half to rule out everything and the best they found was that she had herpes simplex based on the blood work done at that time and it was what her HCP believed it was at that because it showed she had some kind of virus but neither time she had bell's palsy did she have seizure or other symptoms other than the ear ache she had this time. The patient got the second dose of the vaccine on 02Mar2021 and on 24Apr2021 she went to the emergency room with Bell's palsy. She can talk better when she holds her mouth. She was out of town when she noticed the symptoms of bell's palsy the night before on 24Apr2021 and when she got home she then went to the emergency room on 25Apr2021; she could tell something was happening again and it was noticeable and she had an ear ache the day before and her face was drooping. The HCPs swear there was no correlation between the vaccine and bell's palsy but she found this very coincidental. The patient stated that she would rather get bell's palsy again than get covid. For treatment, the only thing she has done was to call the HCP to schedule the follow-up visit as directed by the emergency room (ER) HCP; she went to the ER to rule out stroke and they did rule out stroke; states the only other thing she can think of is that she had quite a bit of stress because they put down her dog on Sunday and other than that she had an ear ache at her granddaughter's track meet on the day before on 24Apr2021 and the emergency room visit was on 25Apr2021. She has had recurrent fever blisters and her HCP has given her a prescription for Valcyclovir and she takes that at the onset of fever blisters and where she gets the fever blisters is constantly on the previous side where she had bell's palsy and was in the same spot on her left side of her lip. States the Valcyclovir she has was one gram tablets and she takes one when she has a fever blister and one 12 hours later; states she has two prescriptions for the Valcyclovir and they are in orange pharmacy bottles with no lot numbers, expiry dates and NDC numbers and the other prescription for Valcyclovir is also 1 gram and she takes it three times per day now after this outbreak. The patient required a visit to the ER or medical doctor office. The outcome of the events was unknown.
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| 67 | 2021-01-01 | pain in extremity | Sore arm ?? |
| 67 | 2021-01-03 | weakness |
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, e...
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On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
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| 67 | 2021-01-04 | burning sensation |
burning sensation in my flank area of left back, extending from the spine. I couldn't wear clothing...
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burning sensation in my flank area of left back, extending from the spine. I couldn't wear clothing because it was unbearable, It lasted until Monday. I texted my friend that is a Dr and he recommended to wait it out. I still get brief sensations but I am more or less over it
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| 67 | 2021-01-04 | cold extremities, flushing |
flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a sponta...
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flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.
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| 67 | 2021-01-05 | pain in extremity | Headache Fatigue; Arm soreness |
| 67 | 2021-01-05 | tingling |
I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to th...
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I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to the ER at Hospital, and was confirmed to have had a stroke in my left thalmus.
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| 67 | 2021-01-06 | tingling |
UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly...
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UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly and under eyes; VS 73, r 16, BP 1589/90, sat 98%. ambulated to MD office Evaluated by Dr. Benadryl ordered (25mg PO x 1 dose) and given at 1305). Ambulated back to personal office, called friend to pick up after work. 1330, 72, 16, 96%, 135/82, denies worsening of symptoms, no rash or hives noted. No symptoms of difficulty breathing, swelling of face or tongue, increased heart rate, rash or dizziness or head ache. Assessment and follow up by M.D.
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| 67 | 2021-01-09 | pain in extremity | Minor pain in arm starting about 10 hours after vaccination and ending by 3rd day. |
| 67 | 2021-01-10 | tremor |
5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, an...
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5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, and shakes that patient attributes to anxiety from possible reaction.
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| 67 | 2021-01-11 | cold sweat |
Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Ins...
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Received vaccine on 1/4. Woke on 1/5 with cold sweats and painful diarrhea. Called Covi hotline. Instructed to stay home form work until symptoms improved.
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| 67 | 2021-01-12 | feeling cold | Developed fatigue, chills, body aches |
| 67 | 2021-01-12 | unresponsive to stimuli |
The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue. Tra...
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The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue. Transferred to hospital by ambulance at 9:11 am and the lady and husband refused to go to the hospital. Released home at 9:27 am.
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| 67 | 2021-01-12 | pain in extremity |
arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still hea...
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arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still heavy/she is yawning a lot more; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 06Jan2021 at single dose in her left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no investigation assessment. It was reported that it had been 24 hours, she received her first bnt162b2 (reported as Pfizer COVID vaccine), yesterday (on 06Jan2021), and she was wondering, her arm was sore on 07Jan2021, which she thought was normal and fatigue on 06Jan2021, she got right away, she didn't know if that was normal, but she got a metallic taste in her mouth on 06Jan2021. It felt like a metallic taste when she swallows, a little metallic taste, yesterday (on 06Jan2021) was more than today, it was after the vaccine, about 7 hours after. She thought in her head, like the aluminum chewing gum, when kids chew it, it had a metallic taste, like the (company name withheld) wrapper she used to chew on it. Provides she was shrinking. Provide she was wearing stretch pants when providing weight. She Googled and didn't see the metallic taste, the only thing she saw with metallic taste is if you have the actual virus, she didn't have it, she was fine. Maybe it was all in her head. Arm was sore not right away, it built up, like when you stretch like with the flu shot, she lifted and it's sore, and she felt sleepy. It was like with the flu shot, it took a few days to go away. Last night on 06Jan2021, she was very sleepy, she was kind of sleepy, but it could be watching the Capitol and insanity, but she was yawning a lot more, her eyes felt heavy, she was ok, she had an appetite and is fine, she would drink (company name withheld) now. Thought she was peaking with it, she would go to sleep early today (07Jan2021), her eyes were still heavy, she wanted to close them and took a nap, but couldn't. It was like her saliva has a metallic taste in her mouth, it may be in her head, she googled to see side effects and when they start, it may be going soon, who knows, she was just wondering. The taste was worse yesterday (06Jan2021), and it wasn't IV or anything like that, the patient wanted to know how can that be. She had to go back on the 27th for her second dose. She had been tested and retested on an unspecified date, and it was offered for those 65 and over, and she was lucky to get an appointment. The outcome of the event metallic taste was recovering; the events fatigue and eyes heavy was not recovered; the outcome of the rest events was unknown.
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| 67 | 2021-01-13 | feeling hot |
Left hand in thumb area and Left wrist patient reported a twinge feeling and was very warm. Blood ...
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Left hand in thumb area and Left wrist patient reported a twinge feeling and was very warm. Blood pressure was 126/80, pulse ox 95 and pulse 73. Gave patient H2O and patient sat another 15 minutes. Left with no more symptoms and vital signs were 120/78, pulse ox 94 and pulse 75
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| 67 | 2021-01-13 | seizure |
Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. ...
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Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.
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| 67 | 2021-01-13 | cold extremities, feeling cold, numbness |
Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side)...
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Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side) feeling cold; patient began to have a headache and left lower jaw felt numb. This was also experienced on lip & cheek. Patient was coherent. not dizzy. Patient was being checked on and stayed to about 2:40 PM when patient could feel the numbness subsiding. At 5:40 PM. Patient has a little numbness and a headache on left side of the head. Patient shot was administered on left arm.
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| 67 | 2021-01-14 | discomfort |
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SIT...
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INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE; RXN TO VACCINE ITSELF: 32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
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| 67 | 2021-01-14 | hot flush, flushing |
Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released h...
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Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released home at 1:20 pm feeling better.
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| 67 | 2021-01-14 | pain in extremity |
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel...
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received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
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| 67 | 2021-01-16 | pain in extremity | sore arm redness at the site chills and fever-101.3 fatigue |
| 67 | 2021-01-17 | numbness |
States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb a...
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States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb and hands felt weak. Did not seek any medical attention. Entirely resolved day of reporting this (1/18/21).
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| 67 | 2021-01-18 | feeling hot |
After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fi...
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After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fire Rescue on site. Client's symptoms resolved and released to go home per Fire Rescue at 10:28 am.
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| 67 | 2021-01-18 | pain in extremity |
I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positiv...
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I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positive for Covid. I developed headaches, cough, congestion along with a sinus infection and had left arm soreness. I also received my 2nd dose injection on 01-06-2021 at 9:30am.
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| 67 | 2021-01-19 | feeling jittery, tremor, feeling hot, flushing |
Flush/warm face followed by dry mouth/tongue and then shakes/jitters. Flush went away but dry mouth/...
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Flush/warm face followed by dry mouth/tongue and then shakes/jitters. Flush went away but dry mouth/tongue and shakes/jitters continued. The monitoring staff kept me under observation for 1.5 hours, and then I left after symptoms mostly subsided. I've never had any adverse reaction to a vaccine or other medication ... although I tend to be medication sensitive so I avoid it if possible. My only allergies are seasonal/pollen (outdoor) and some indoor (mold, etc.) What was my reaction? Can I take the 2nd dose or not?
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| 67 | 2021-01-19 | pain in extremity, numbness, tingling |
Neurological symptoms. Stabbing pain in left foot, numbness and tingling in both legs and arms. Pa...
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Neurological symptoms. Stabbing pain in left foot, numbness and tingling in both legs and arms. Pain woke me up in the middle of the night. Took Gabapentine 300 mg. , two doses. Pain resolved the next day.
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| 67 | 2021-01-19 | tingling, flushing |
Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second ...
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Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second Pfizer vaccination. Pt reported a blister like rash on her chest after receiving the first dose. Hx of hives with adhesives and latex, occasional rash with tylenol. Pt reported a flushing sensation and swollen lymph nodes in neck 30 minutes after administration. Pt reported tingling in her hands shortly after. BP: 135/73 HR: 72 O2: 100% Pt denied SOB, swelling of face/tongue/throat, difficulty swallowing, nausea, itchiness, dizziness. No visible swelling. Paged Allergy (Itchy). Advised to give Zyrtec 10 mg and observe to see if there is any improvement. Symptoms improved 15 minutes after administration of Zyrtec 10 mg. Pt sent home and advised to continue to take antihistamines as needed
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| 67 | 2021-01-19 | tingling |
aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to ...
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aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to hands, denied difficulty breathing. 11:25 client denies any tingling at this time. She was released to her husband and told to monitor her symptoms.
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| 67 | 2021-01-20 | numbness |
Pt reported left arm numbness & light-headedness. AAOx3. EMTs arrived and offered a snack and a dri...
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Pt reported left arm numbness & light-headedness. AAOx3. EMTs arrived and offered a snack and a drink. Released after brief monitoring.
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| 67 | 2021-01-20 | numbness |
Pt reported left arm numbness & light-headedness. AAOx3. Rapid response arrived and offered a snack ...
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Pt reported left arm numbness & light-headedness. AAOx3. Rapid response arrived and offered a snack and a drink. Released after brief monitoring.
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| 67 | 2021-01-20 | unresponsive to stimuli, muscle twitching |
She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures seco...
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She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures secondary to cancer, low grade temp of 99.4 for which she was given tylenol. After the tylenol her fever broke but the lip twitch persisted and her body began to twitch intermittently. She continued to have the twitching throughout the evening and then became unresponsive. She was sent out EMS to our local hospital. She was admitted and returned from the hosptial on 1/19/2021 and state she feels fine. New Diagnosis of Metabolic Encephalopathy
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| 67 | 2021-01-21 | pain in extremity, weakness | 1/7 6:30PM TO 1/8 1PM: ARM PAIN FLU-LIKE SYMPTOMS CHILLS, HEADACHE, BODY ACHES WEAKNESS TOOK TYLENOL |
| 67 | 2021-01-21 | flushing, weakness, feeling hot |
12/27 vaccination 12/30 felt good all day. Ate supper. Sat down to watch news, read. At about 8 o'c...
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12/27 vaccination 12/30 felt good all day. Ate supper. Sat down to watch news, read. At about 8 o'clock, i had almost collapsed out of the chair. I was extremely flushed, never felt so hot in my life, thought i was going to pass out. I got to the floor, I was extremely weak. I had a hard time getting up. I made the call to my dr answering service. I did get up and get some water. I took my BP evening meds, it was in the 200's/90-100. When dr called me, i relayed info. Words not slurred, no paralysis. Extreme sensation of being flushed. O2 stats were good; 96-100%. I went to local emergency in my neighborhood. 'uncontrolled pain' BP 192-100
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| 67 | 2021-01-21 | feeling hot |
6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINES...
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6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINESS-STILL HAD CHILLS. TYLENOL 2 TABS, WATER AND GATORADE.
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| 67 | 2021-01-21 | burning sensation, pain in extremity |
General malaise with burning sensation inside the body, no fever registered; inflammation of right a...
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General malaise with burning sensation inside the body, no fever registered; inflammation of right arm and hand/wrist, migratory joints pains, muscle pain, stabbing pains sudden, neuralgic pain in the extremities. Pain was so severe that cause limitation for walking around the house. The last event on the 7th day was inflammation of the right foot and ankle with severe pain with no history of sprain or trauma.
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| 67 | 2021-01-24 | weakness, pain in extremity |
The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .aft...
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The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .after the 3 days i went back to normal on Jan 22 i wake up with pain in left arm i thought it was due to my neck issue Sunday the 24 th noticed that my Arm is swollen and red check with a primary care provider and been told that i hv cellulitis that he thinks it is from the injection . The Physician prescribed immediately doxycycline 100 mg twice a day for 10 days .. on the 25 i informed my care provider . I started the Antibiotics Jan 24th at 8:00 pm.
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| 67 | 2021-01-24 | pain in extremity |
yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous re...
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yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. Medical history included lung condition, sarcoidosis, immune system problems, ongoing headache and migraines. Concomitant medication included topiramate for headache and to ward off migraines. States it is in a white bottle, but a pharmacy bottle from (Pharmacy name). She provides discard after 18May2021. Now clarifies it is Topiramate, the generic, 50 mg, it helps ward off migraines. She sees a neurologist for this, not by her internist, she sees the internist who prescribes it twice a year, actually, it is so her headaches don't turn into a migraine, this is just a worse headache, she doesn't know what this is from, hopefully it will just get better. The patient previously took codeine and experienced drug allergy. It was reported that she received the first dose of the vaccine on Wednesday, 06Jan2021. Patient reported that "she's a headache person and gets them all the time." Per the reporter, late yesterday on 10Jan2021, she got a really, really bad headache, that she still have. Could this be vaccine related this far out? The only thing she got right after the vaccine was a sore arm. It's not debilitating (the headache). She is going through a few stressful situations with a friend and her son going through a divorce. She do have a lung condition that's now in remission. She was being followed by a pulmonologist and she is taking something. She is allergic to codeine. She will continue to take Tylenol and will continue to just deal with it." She said that her husband believes the current headache is related to stress. It was further reported that she got the vaccine last Wednesday, on 06Jan2021, she is a headache person, she gets headaches all the time, and takes Topamax (later clarified as the generic, topiramate) on a daily basis, but yesterday on 10Jan2021, late afternoon, she got a really really bad headache, that is still there today, but she didn't get it right after the vaccine, she wondered is that related, or would she have gotten it right away, the headache? States it is not horrible bad, it's just a bad headache, she still wants the second vaccine, and she doesn't want this to interfere, she has a lot of medical conditions, this is why she was afraid to call. Her husband doesn't think this has to do with the vaccine, but she felt like, let her just call. She still has it (headache), she is a headache person, it got better then she got it again, and it also could be stress related, she has been dealing with a few things: she has a friend giving stress, her son is going through a divorce. But she did not get it right after the vaccine, the vaccine was early Wednesday, which is why her husband doesn't think it has to so with anything. Also, she has a lung problem, and thank god she is in remission, she has sarcoidosis, and she has immune system problems, so she has medical reasons. But the issues most important are the lung. She is having blood work done tomorrow, so it has nothing to do with it. States this is good to tell about the stress: she has a friend, a toxic friend, she lives in (State Name), the friend lives in (City Name), and she is a negative person, and she is ending a longstanding friendship, which is not like her, so that is weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine, she thought to call and see. She can definitely get the second dose, right? This report doesn't affect her getting the second dose? After reviewing the call recording, there is no mention of the friend getting the vaccine. The reporter said her friend is giving her stress, and in regards to the statement "weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine", the reporter was referring to herself. Additionally, the statement "But she did not get it right after the vaccine, the vaccine was early Wednesday" the reporter was also referring to herself. The outcome of the event 'headache' was not recovered while unknown for the other event.
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| 67 | 2021-01-27 | burning sensation, tingling |
10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burn...
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10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burning, tingling at rash site. Patient also felt thirsty (was then given water). Benadryl oral was given, but symptoms did not resolve and patient began to feel feverish and dizzy. Itch worsened and spread throughout body. Dexamethasone oral was given 15 minutes later. Itching started in mouth. EpiPen was administered intramuscularly to left vastus lateralis. Hypertension was noted post administration. Itching in mouth subsided, but patient began to feel shaky and still felt dizzy. Monitored for additional 20 minutes. After, patient was stable, walked out via wheelchair enroute home.
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| 67 | 2021-01-27 | hot flush |
After administration, the client complained of feeling flushed. Pt was assessed after one minute BP...
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After administration, the client complained of feeling flushed. Pt was assessed after one minute BP 138/62 O2 99% Pulse 59 at 1107. 1115 BP 138/70 O2 98% Pulse 68.
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| 67 | 2021-01-27 | facial paralysis |
SINTOMES 3 DAYS , CHILLS,HEADACHE ON RIGHT SITE,PAIN ON RIGHT EAR THIS WAS ON 01/26. ON 01/27/2021 ....
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SINTOMES 3 DAYS , CHILLS,HEADACHE ON RIGHT SITE,PAIN ON RIGHT EAR THIS WAS ON 01/26. ON 01/27/2021 . SHE HAD A DEVATION OF THE MOUTH TURN TO HER LEFT SIDE SHE HAD FACIAL PARALISIS CONTINUE WITH SINTOMES HAS APPOINMENT WITH PHYSIATRIST 01/28/2021.
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| 67 | 2021-01-27 | numbness, weakness, tingling |
Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that ...
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Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that about 12 hours later developed extreme fatigue, all over weakness, headache, she also c/o intermittent numbness & tingling in bilateral lower extremities (mid-calf to toes) she states that she also has Resless Leg Syndrrome that is untreated. Has been in contact with her PCP. Encouraged her to "Self-Report" to the Vaccine's web-site listed in the Vaccine handout. Encouraged her to call back if she has further concerns or questions.
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| 67 | 2021-01-28 | tingling, numbness |
1/28/2021 02:38:41 PM > 1410: Patient c/o numbness and tingling to L arm approximately 7 minutes aft...
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1/28/2021 02:38:41 PM > 1410: Patient c/o numbness and tingling to L arm approximately 7 minutes after receiving injection with no other complaints, nurse added additional 10 minutes to observation time. 1430: Patient states numbness is getting better, nurse encouraged patient to go to nearest ER if problem persisted. RN 1/29/2021 08:55:46 AM > contacted patient to f/u, message left
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| 67 | 2021-01-28 | pain in extremity |
Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nu...
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Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nurse had me drink some water and eat some nuts. I had drunk some glucerna that morning for breakfast with my medication. The RN had me wait for about an hour. I then called my primary care doctor who told me to go home and rest. He said that I did not need to go see him or go to a clinic or Emergency Room unless I felt worse. (I have progressively felt better). I left his number and contact information under the contact information above. However, I had received the shot from the Hospital site. I am providing this as you were a little vague in your question about contact address. Anyway, my husband took my temperature about 6 pm. I had a temperature of about 93.8. I normally have a temperature of 98.6 F. He used a digital thermometer. However, I did not feel as if I had asthma. I did have a slight headache then and my arm was a little bit sore. Today (the 29th) my temperature is about normal. I do not have any breathing problems, but my arm is a little bit sore where I got the shot. I still have a slight headache, but it's not too bad. I don't need to take medication for it. There is no redness at the site of the injection. I should mention that one of the RN's did look at my fingernails and the color was normal which I assume means no problems with oxygen levels. I am only reporting this because of the extreme dizziness! I felt a lot better after about an hour after taking the shot, drinking the bottle of unflavored (still) water and eating the nuts. My A1C is back to normal today. (and remember I am not currently needing or taking any form of insulin but my doctor has my blood checked regularly and has for many years). I am only putting no on the item number 20 below because I still have a slight headache and a little bit of soreness in the injection site. Today the site of the injection is not red either.
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| 67 | 2021-01-28 | pain in extremity, tenderness |
Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right a...
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Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right armpit, started 24 hrs post vaccine, still occurring; no treatment for anything
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| 67 | 2021-01-28 | discomfort, pain in extremity |
Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before....
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Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before. Duration 1-2 hours. Night 4 woke 2 am with more intense discomfort left knee, again not like anything experienced before but did not require Tylenol. It was gnawing and annoying, Night 5 woke around 4 am with left lower leg/ side of foot mild ache which lasted a few hours. Stretching, changing positions had no effect on any of three nights. Day after vaccine while exercising I perspired more than usual and was tired. Did not concern me in any way and would not have reported unless had above symptoms. Question- Do any of the above symptoms indicate I should not get dose 2? Thank you
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| 67 | 2021-01-28 | feeling hot, flushing | Patient developed a full body flushing/warmth sensation. Sent to the ED. |
| 67 | 2021-01-28 | tingling |
Pt developed pins/needles sensation in right hand 10 minutes post-vaccination. wrist to finger tips...
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Pt developed pins/needles sensation in right hand 10 minutes post-vaccination. wrist to finger tips. Denies pain, numbness. Assessed by RN (denies airways, breathing, swelling problems). Denies hives
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| 67 | 2021-01-28 | muscle spasms | Strong muscle cramps/spasms in stomach and upper abdomen, primarily on left side. Mild nausea |
| 67 | 2021-01-28 | tremor, pain in extremity | shaking chills body aches headache fatigue red sore arm |
| 67 | 2021-01-28 | burning sensation |
shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain ...
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shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain and dizziness. the pain is very intense causing me to lay down and close my eyes. This has happened everyday for two weeks now. everyday is the same and has not gotten better.
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| 67 | 2021-01-29 | tingling |
No problem with injection site. Developed what appears to be a rash (hives?) on my right side at my...
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No problem with injection site. Developed what appears to be a rash (hives?) on my right side at my waistline. Noticed two spots and at first thought it was bug bites. Since Wednesday, several more spots have appeared in same area around waist from navel area around to back. Spots are not large or itchy but have an occasional mild sensation like a twinge (mostly from the new spots). Been self-treating with witch hazel, hydrocortisone cream, fexofenadine and acetaminophen. Note: I am assuming this is a side effect from Covid vaccine because I have never before had hives. I had a senior flu shot in October with no side effects.
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| 67 | 2021-01-29 | numbness | slight numbness in right side of head lasting approximately 10 minutes |
| 67 | 2021-01-30 | seizure |
Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husb...
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Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husband 'I don't feel well'. Immediately my eyes rolled back and convulsions started. Then I passed out. EMTs were called over to car and started to administer oxygen. I woke up about 6:30pm cognizant of surroundings. BP was normal. No fever, no rash, no chills. I was just tired. Then 2 hours of vomiting started. Last vomit about 8:15pm in ambulance. EMT unable to administer IV. After waiting in ER waiting room for 45+ minutes, a bed was available (around 9pm). ER doctor gave me ondansetron ODT 4mg Once. Released at 10:12pm to go home. Next 3 days symptoms of lightheadedness and dull headache.
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| 67 | 2021-01-31 | grand mal seizure, seizure | Seizure, 60 sec generalized clonic-tonic |
| 67 | 2021-01-31 | facial pain |
Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux dise...
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Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux disease), symptoms started at 11:30PM while in bed and lasted 1-2 hours; sudden onset and dissipation
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| 67 | 2021-01-31 | weakness |
day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipat...
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day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipated with only small soft BM after product use; self care
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| 67 | 2021-01-31 | tingling, numbness |
tingling and numbing on left side of torso around rib cage, movement medially and down over a few da...
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tingling and numbing on left side of torso around rib cage, movement medially and down over a few days.
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| 67 | 2021-02-01 | tremor, weakness, feeling of body temperature change |
Itching at injection site within 3 minutes or less from time of injection, After two to three minute...
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Itching at injection site within 3 minutes or less from time of injection, After two to three minutes of the itching episode, heart racing followed by palpitations. Followed by chest tightness over heart area. Followed by shaking in upper torso and arms and hands. Became nauseous followed by weakness and a need of a wheel chair to get to my car. A few hours after arriving at home, itching started all over my body and nausea persisted through the night. Itching became stronger. The morning after the shot explosive diarrhea. Fatigue, chills and hot and cold feelings the following day as well as itching persisted. Now, two days later, itching remains with intermittent mild chest tightness which is abating and taking zytrec for the itching
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| 67 | 2021-02-01 | numbness |
Pinched nerve, pain on injection site, numbness of fingers. Describes pain as shooting pain in finge...
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Pinched nerve, pain on injection site, numbness of fingers. Describes pain as shooting pain in fingers. Stabilized - discharged to home. BP/pulse: 154/70, 81; 154/76, 82. O2 sat 100%.
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| 67 | 2021-02-02 | pain in extremity |
This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female...
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This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 29Dec2020 around 10AM at left arm at single dose for COVID-19 immunization. Medical history included allergic to penicillin. She also had an allergy to anesthesia but was told this was irrelevant to the shot, this allergy was over 20 years ago. Ongoing acid reflux, she had a problem with acid reflux for a year (it was controlled on medication) but they made changes to her medication and started to come back. She stated it was not real bad and that this wasn't a side effect because she has been dealing with it for a year. Concomitant medications were none. No other vaccinations within 4 weeks. The patient stated she received her first dose of the vaccine and didn't have any problem with it, just that her arm was sore and ached but by the next morning it was gone. The arm soreness happened maybe 12 hours later after she took the shot. She didn't experience it immediately after getting the injection. The soreness lasted overnight and by mid morning of 30Dec2020, she recovered completely. She stated this morning (18Jan2021) she woke up with a sore throat and her ear started to throb and she asked if it is safe for someone to receive the second dose if they are not feeling their very best? She is scheduled for her next dose tomorrow. The events did not require a visit to emergency room or physician office. Patient stated she was not sure about her weight because she lost a lot of weight dealing with the acid reflux she had had lately. Lab data included she had two COVID tests because of work previously, but these were negative. The outcome of arm soreness was recovered on 30Dec2020, outcome of other events was unknown. Information on the LOT/Batch number has been requested.
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| 67 | 2021-02-02 | weakness | headache, weakness, body aches, high blood pressure |
| 67 | 2021-02-03 | tenderness |
3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tendern...
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3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tenderness in my hand and wrist, by the 3rd day, I woke with throbbing pain in my knuckle joint with swelling and redness. Since then, the swelling and pain has progressed to additional knuckles in my left hand and into my right hand. There has also been joint pain in my left shoulder that resolved. Yesterday my right knee began to hurt. I've used ice packs and alternated between ibuprofen and acetaminophen for the pain. The swelling has somewhat improved but has not resolved. The pain is still present. I've had occasional join pain before but nothing like this and it has always resolved. Not sure if this has anything to do with the vaccine, but since joint pain was listed as a side effect, I thought I should report it. Have not contacted my physician yet.
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| 67 | 2021-02-03 | feeling hot |
Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin le...
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Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin lesions 4.5 to 7cms/Red spot on my arm; Low grade temperature elevation; Fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899, reported as "SARS-COV-2 then it says Pfizer EH9899", expiry date: Unknown), subcutaneous on 05Jan2021 at single dose for COVID-19 immunization (reported as "To not get COVID 19"). Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) 25mcg, once a day for hypothyroidism. The patient got the vaccine last Tuesday (05Jan2021). When she got the vaccine, the gentleman was from military who gave the vaccine. The patient does not believe that he gave it intramuscular (IM), she believed that he gave it "subQ" because she had no muscle tenderness and "skin a 4.5 by 7cm skin reaction", and it was nowhere near the deltoid muscle. The patient had a high degree of suspicion that he gave it "subQ" (subcutaneous). When asked for the anatomical location of administration, the patient stated that "He gave it on my right arm but it was not into the deltoid, I think he gave it subcutaneously. I am not positive of that but missed the deltoid, it was lower, it was below the deltoid, it was in between the deltoid and the bicep and I am assuming it was subQ because none of my muscles were sore at all after getting the vaccine, accept that big red spot on my arm". Patient asked "Now my question to you is because I looked through all your literature and I can't find anything about this". Since then the skin lesion within a couple of days it was up to about 4.5 to 7cms. It was still about that size however the redness has gone way down, "the not redness", just pink, the swelling was almost gone. The heat coming out of it was almost gone. The patient mentioned that the actual skin region was much better, it was still about the same size though. Patient was not too worried about that and stated "what am concerned about is what I've also have is a low grade temperature elevation and some fatigue. If I got it on 3 O'clock on Tuesday the 5th that would be day 9. Is the 9 days post injection for dose 1 to still have a low grade temperature elevation and some fatigue. Is that acceptable or does that indicate a problem?". Patient stated the she went to her internist and he had a look at it and he said "I had no idea, he said that they just don't have experience like this. Do you have a phone number that I can talk to somebody?". The patient was about 5' 7" (height) and about 175 pounds (weight) approximately. The patient stated that fatigue and temperature elevation started one or two days after the vaccine (Jan2021). Patient reported that she still have it. The fatigue was much less but it was there and low grade temperature elevation was still there. There was no investigation assessment. The patient assessed that the events swelling, redness, skin lesions, temperature and fatigue were related to COVID-19 vaccine, also reported as "Yes, because I never had that before and I am not taking anything now. So, it is like yes. It is definitely because that. The two main symptoms I am asking about are the fatigue and the low grade temperature elevation". Outcome of the events fatigue and skin lesion, redness, swelling and heat coming out was recovering, for low grade temperature elevation was not recovered.
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| 67 | 2021-02-03 | pain in extremity |
Her arm hurt for about a week; This is a spontaneous report from a contactable consumer (patient). A...
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Her arm hurt for about a week; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiration date: unknown), via an unspecified route of administration on the right arm on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetes, ongoing hypothyroidism, high cholesterol and allergy. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) and montelukast sodium (SINGULAIR) - both ongoing and for allergy. No other vaccines administered on the same date with the Pfizer vaccine. The patient stated that she did okay with the first dose, and her arm hurt for about a week on an unspecified date. The outcome of the event was unknown.
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| 67 | 2021-02-03 | hot flush |
Pt co lightheadness. Also complain of hot flashes. 1705 bp 147/71; p 72, rr 20, 02 99 1710 bp 139/...
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Pt co lightheadness. Also complain of hot flashes. 1705 bp 147/71; p 72, rr 20, 02 99 1710 bp 139/64, p 80, rr 20, 02 99; 25 mg Benadryl given po 1712 - c/o lips and tongue tingling 1715 - 135/69, 65, 100% 1715 - tingling improving 1720 - 138/68, 66, 99% 1725 - tingling gone, lightheadness impoving; pt stood by chair without complaints 1730- 125/55, 66, 99%; pt feels better; pt assisted out to car.
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| 67 | 2021-02-03 | migraine |
The vaccine is metabolized through CYP450 same as the topiramate. On day 7 after the second vaccinat...
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The vaccine is metabolized through CYP450 same as the topiramate. On day 7 after the second vaccination, my migraines returned. They have been under complete control for over 5 years. I have had to increase the dose of topiramate in order the stop the migraines somewhat. My main concern is that topiramate is also used for seizures. If a person taking this for seizures has the same reaction as I did, they may have seizures shortly after their second dose of the MRNa vaccination (either Pfizer or Moderna).
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| 67 | 2021-02-03 | numbness, tingling |
inside of her mouth felt weird; hands starting to tingle and felt a bit numb; hands starting to ting...
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inside of her mouth felt weird; hands starting to tingle and felt a bit numb; hands starting to tingle and felt a bit numb; lower lip started swelling up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 01Jan2021 (10:45) at single dose for Covid-19 immunization. Medical history included Hashimoto's thyroiditis, uveitis, and known allergy to some antibiotics, artificial preservatives, artificial colors, many foods like egg, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), bimatoprost (LUMIGAN), timolol, and vitamin D3; all taken on unspecified dates for an unspecified indication. The patient previously took Benadryl and Aspirin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that an hour after the vaccine (01Jan2021 11:45), the patient's lower lip started swelling up. Then it got worse and the inside of her mouth felt weird on 18Jan2021 (11:45AM). The patient's hands starting to tingle and felt a bit numb on 18Jan2021 (11:45 AM) (as reported-pending clarification). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with Prednisone 40mg. The outcome of event lip swelling was unknown; while the outcome of other events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 67 | 2021-02-03 | feeling hot |
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she start...
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one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-02-04 | feeling cold, pain in extremity, night sweats |
Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable ...
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Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Blood pressure, ongoing Cholesterol. Concomitant medication included nifedipine (ADALAT) for Blood pressure and ongoing, atorvastatin (ATORVASTATIN) had been on this medication 6-7 year and ongoing for Cholesterol. Historical Vaccine included flu and had Soreness in her arm. The patient experienced soreness in arm on 20Jan2021; chills, cool, fever, night sweats on 21Jan2021. She woke up drenched. She imagined the fever was breaking. She woke up, and did not have a fever, and was fine other than that; She just couldn't warm up. She was cool, and the chill wouldn't go away with clothes or blankets or the fire place. The event outcome of soreness in arm was recovering, outcome of other events was recovered on 21Jan2021.
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| 67 | 2021-02-04 | speech disorder, feeling cold, slurring, tingling |
I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45...
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I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45. I was discharged Tuesday evening 2/2/21. Dr., my internist, agrees that what happened was not a vasovagal syncope (hospital?s diagnosis). My Experience: Within say 7 minutes of the injection I felt woozy, the wooziness intensified, I got intense pins and needles in my lower legs, fore arms and hands, and less so in my face. My speech became very slowed down, slurred and I had a lot of difficulty forming words. It was as if I was extremely drunk. After they called the paramedics, I was not able to get myself out of my car or walk. I lost motor coordination/control in hands and feet. I was cold, never felt faint, and had slightly evaluated blood pressure for me( normal is 110/64 paramedics got it at 152/94).
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| 67 | 2021-02-04 | numbness |
bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued...
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bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued; This is a spontaneous report from a contactable Nurse (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685, expiration date unknown), intramuscularly in the left arm, on 28Dec2020 as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 28Dec2020 the patient experienced fatigue. On 29Dec2020 the patient states that her feet were numb bilaterally and her hands felt weak. The patient did not seek any medical attention and no treatment of the events was reported. The clinical outcome of fatigue, numbness of feet and weakness of hands was recovered (reported as "resolved entirely on its own") on an unspecified date.
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| 67 | 2021-02-04 | unresponsive to stimuli |
found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breat...
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found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
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| 67 | 2021-02-04 | numbness |
left arm numbness; lightheadedness; This is a spontaneous report from a contactable pharmacist. A 67...
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left arm numbness; lightheadedness; This is a spontaneous report from a contactable pharmacist. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), intramuscular on 22Dec2020 10:15 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital. Patient is not pregnant. Medical history included latex allergies. The patient's concomitant medications were not reported (unknown if there are other medications in two weeks). The patient previously took codeine, ibuprofen and prednisone and experienced allergies. No other vaccines in four weeks. No COVID prior vaccination. The patient experienced left arm numbness and lightheadedness on 22Dec2020 at 10:15 AM. Patient was awake, alert and oriented to date, place and person (AAOx3). Rapid response arrived and offered a snack and a drink. Patient was released after brief monitoring. No treatment was given for the events. Outcome of the events was recovered on an unspecified date. Patient was not tested for COVID post vaccination.
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| 67 | 2021-02-04 | pain in extremity |
received both shots): first - 1/9; second 1/30 normal arm soreness at first which went away; then ye...
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received both shots): first - 1/9; second 1/30 normal arm soreness at first which went away; then yesterday woke up and the arm is very warm to the touch and red about 4in by 3in at the injection site; no symptoms at all after the first reaction
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| 67 | 2021-02-07 | weakness |
15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs ob...
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15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs obtained by EMS BP 119/72, Pulse 72, Temp 99, O2 sat 96% Blood Sugar 107 at 1:43 pm. Client was wearing 2 face masks. She removed the mask and stated she feels better. States she was hungry. After EMS obtained 2 sets of vitals within normal limits, patient stated she felt better and was discharged home by EMS at 1:45 pm.
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| 67 | 2021-02-07 | pain in extremity |
Eczematous type papule appeared at area of left bicep, and that area had ached for a month.-and stil...
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Eczematous type papule appeared at area of left bicep, and that area had ached for a month.-and still does sometimes. The needle entered very high on the left arm. It felt like the administrator of the vaccine hit a tendon or my bone! She jabbed the deltoid very high (too high) and very hard. The second vaccine I had received three weeks later was given in the right arm, lower, and there has been no problem.
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| 67 | 2021-02-07 | pain in extremity |
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; D...
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Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity. On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 67 | 2021-02-07 | throat numbness |
Pfizer covid 19 Bio Tech vaccine administered at 11:20 am. At 11:40 am I began feeling odd- fuzzy an...
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Pfizer covid 19 Bio Tech vaccine administered at 11:20 am. At 11:40 am I began feeling odd- fuzzy and light headed. Ears began to ring loudly. Lips became tingly and numb. Throat and tongue became tingly and numb. At 11:50 we had returned to clinic. 50 milligrams of Benadryl were administered. Blood pressure 120 over 60 (a bit high for me but anxiety accounts for that) . Pulse 60- normal for me. After being observed for one hour symptoms diminished and we left clinic. After 2 more hours all symptoms gone.
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| 67 | 2021-02-07 | tremor |
Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizzi...
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Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizziness and headache. I then experienced tightness in the center of my chest and a generally mild shakiness. After waiting my 20 minute observation time, I recovered enough to drive home. However, mild mental fogginess, headache, tightness in chest and generally feeling unwell remain for 24 hours.
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| 67 | 2021-02-07 | numbness |
Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, che...
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Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, chest pain, bilat leg numbness, no hives present, denied difficulty swallowing. Pt was brought to a room, placed on 02 10L by face mask. Initial BP 200/105 HR 116. Pt became non-verbal, PA-C dx'd stridor, epi 0.3mg was given deep IM to right thigh. Pt responded positively, within 2 mins, pt became alert and was able to respond to questions. EMS was contacted, arrived and took pt to hospital. She was unable to ambulate c/o of all over body numbness, racing HR. Pt was admitted for observation at Medical Center.
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| 67 | 2021-02-07 | feeling hot |
blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous re...
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blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 21Jan2021 at 14:45 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included a history of asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination or additional vaccines on the same day. On 21Jan2021 around a half hour after administration (also reported as within 40 minutes) the patient started having symptoms of suddenly felt very warm, her blood pressure went up considerably and her heart was racing. The patient went to Urgent Care and Urgent Care advised to take her to the Emergency Room as they did not have an EpiPen. The patient was advised to go to the Emergency Room and was in transit to the ER. The clinical outcome of the events blood pressure increased and palpitations was not recovered; for feeling hot it was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 67 | 2021-02-07 | feeling hot |
face got even hotter/her face felt warm; mild allergic reaction; scalp itchiness moved to the back o...
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face got even hotter/her face felt warm; mild allergic reaction; scalp itchiness moved to the back of her neck down the middle of her back; eyes started to itch; arm soreness/it felt like a bruise; arm soreness/it felt like a bruise; This is a spontaneous report from a contactable consumer(patient). The 67-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration in the right arm on 20Jan2021 14:05 at single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), hot flashes, Cholesterol, clear her lungs, eyes(disorder), hair(disorder), high cholesterol, heart(disorder), arthritis in hip and knee, face felt warm from 2015, quit smoking, back pain. In 2015 she had a reaction to a cortisone shot in her knee and experienced her face felt warm. She got a spinal epidural last Jan2020, she had gone to an allergist prior to the spinal epidural to take a five hour test for allergy to dexamethasone and had a very mild reaction with face warming so she did get the spinal. When she got a flu shot her arm would be sore when she moved it. Her last flu shot(Infs Fluarix Quadrivalent) was on 24Sep2020 at his 67-year-old. she usually didn't have issues with vaccines but she was going to make herself wait the 30 minutes due to her weird reactions. She had a lot of weird reactions to medications and always had to wait 30 minutes for Penicillin and sulfa. Penicillin put her in a coma for two days when she was 7 years old. She has never had penicillin since then. with Sulfa she got an immediate rash and itching but that was 20 years ago. She couldn't take pain killers and lots of other medications including clindamycin; Neurontin; gabapentin; carbamazepine; endocet; metoprolol; tamalor. The pain medication issue happened in 2003 and the metoprolol issue happened in 2008. Ongoing concomitant medication included aloe vera for hot flashes and GERD, acetylsalicylic acid (ASPIRIN) for high cholesterol and heart, biotin for hair, cod liver oil to clear her lungs(like a heart supplement), famotidine for GERD, chondroitin sulfate sodium/glucosamine (GLUCOSAMINE AND CHONDROITIN) for arthritis in hip and knee, lansoprazole for GERD, latanoprost for eyes, lovastatin for blood cholesterol, xantofyl (LUTEIN) for eyes , zeaxanthin from 21Jan2021 for eyes and multivitamins(women over 50) for supplement. On 20Jan2021, the patient experienced a mild allergic reaction to the vaccine, only had a mild reaction, she had a mask on and when she got in the car and took off the mask, her face felt warm; Her reaction(face getting warm) was similar to what she experiences with a cortisone shot and dexamethasone before. The face feeling warm happened about 35 minutes after the vaccine(20Jan2021 14:40), then she got home and her face got even hotter; her scalp started to itch, it was really itchy; her eyes started to itch and then the scalp itchiness moved to the back of her neck down the middle of her back for about 2 hours. All of the itchiness went away after about three hours or 17:00PM on 20Jan2021; then a little bit of the scalp itching came back for about 45 minutes and then went away. All of the itching has been gone since evening on 20Jan2021. Later that night on 20Jan2021, she noticed she had a little bit of arm soreness; it felt like a bruise; when she laid on it hurt. 21Jan2021 it had gone away, too. The arm soreness wasn't even as bad as the flu shot. She was scheduled to receive the second dose of the Pfizer COVID 19 vaccine 10Feb2021. Outcome of arm soreness/it felt like a bruise was recovered in 21Jan2021, of other events was recovered on 20Jan2021.
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| 67 | 2021-02-07 | pain in extremity |
terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (pa...
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terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3749), intramuscular on 20Jan2021 15:30 at a single dose on left arm for COVID-19 immunization. Medical history included ongoing COPD, diagnosed probably 7 years ago. There were no concomitant medications. The patient's arm began to get sore the day after receiving the vaccine, 21Jan2021. She had a CAT scan earlier last week, but this was prior to the vaccine. She had the terrible case of diarrhea this morning, 22Jan2021, but she hasn't had diarrhea since then. She got up this morning. She was feeling fine, she drank 2 cups of coffee. She was pouring herself a cup of orange juice, and she had a terrible case of diarrhea. The outcome of the event diarrhea was unknown, arm is sore was recovering. Vaccination Facility Type was Physician's office. Adverse events did not require a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
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| 67 | 2021-02-08 | tremor | Hand tremor; BP 167/78; 156/78 (pulse 84, 78). Advised to f/u with PCP regarding high BP. |
| 67 | 2021-02-08 | weakness |
Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some pe...
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Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some periods of weakness, muscle ache, joint ache, a bit of nausea and headache; soreness, swelling, and redness at injection site; intermittent itching at injection site and upper body
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| 67 | 2021-02-08 | weakness |
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw...
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Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-02-08 | numbness | Right arm and right side of neck went numb between 08:40am and 09:10am. |
| 67 | 2021-02-08 | feeling hot, pain in extremity | Woke up with pain in right arm. Arm warm - could not sleep |
| 67 | 2021-02-09 | numbness, cold sweat, pain in extremity, feeling cold |
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a...
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Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
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| 67 | 2021-02-09 | tingling |
Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of...
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Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E19262 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included peanut allergy. Patient was not pregnant at the time if vaccination. There were no concomitant medications. The patient experienced muscle pain left arm for 20 hours. Pain in arm muscle only when moving arm. Her left foot felt like electric shock, vibrated and was stiff and out of control for 7 times during same time as arm pain. Each episode lasting only 2 to 3 seconds. The events happened on 21Jan2021 12:00. Patient recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 67 | 2021-02-09 | numbness |
Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minut...
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Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minutes, then began to subside - the swelling and numbness in face and lips first and then the itching of rash - rash went away and also itching and redness in eyes
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| 67 | 2021-02-09 | weakness |
chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient)...
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chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 67-year-old female patient received first dose of bnt162b2 (lot/batch number not provided), via an unspecified route of administration on 21Jan2021 at 1:00 (unspecify AM/PM) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose of vaccine, on the 4th day (25Jan2021) she feels weak, have chills and no fever. It was reported that it has been four days since she had her first Pfizer injection of Covid vaccine. Stated that she is feeling very tired, weak and has no chills (pending clarification). Stated that she is four days into it. Stated that she had the vaccine at 1:00 on 21Jan. Stated that she has the list with chills which says that they are normal. Wanted to know if this is normal. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-02-10 | pain in extremity |
12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/...
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12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/21. Ibprofen and increased fluid whiched helped alliviate some of the symptoms
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| 67 | 2021-02-10 | involuntary muscle movements |
Patient received the vaccine on 2/1/2021 in her left arm. On Friday 2/5/21 she developed a markedly ...
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Patient received the vaccine on 2/1/2021 in her left arm. On Friday 2/5/21 she developed a markedly enlarged painful right submandibular lymph node that progressively enlarged until it was difficult for her to open her mouth. She has also had left ear pain but a normal exam. No fever. No tooth pain. No sore throat
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| 67 | 2021-02-10 | tremor, feeling cold, pain in extremity |
The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I we...
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The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I went to bed. I started having generalized pain, all my muscles became achy and my R arm was so sore I could not move it. About 1 am the next morning, I became nauseated and retching. I stared sweating and chilling, my body was shaking so bad I could not hold my thermometer. That lasted possibly 5 minutes, fever 100.8. Episodes of sweating alternating with cold chills occurred the remainder of the night. Exhaustion set in and I could not get out of bed. I was on bedrest all morning and I began to feel better around 4-5pm the next day.
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| 67 | 2021-02-11 | weakness |
On Christmas day I was working and then you started feeling like a pinching in my chest, like when y...
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On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.
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| 67 | 2021-02-14 | numbness |
At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm...
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At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm was hard and soar to wrist. couldn't make fist. joints throbbing. foot swollen and couldn't lift up arm. Feeling like getting flu. Most symptoms lasted 1 week- last reported 2/11/2021.
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| 67 | 2021-02-14 | feeling hot |
During screening, patient stated she has tested positive while in Ohio in early January, had symptom...
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During screening, patient stated she has tested positive while in Ohio in early January, had symptoms of headaches and loss of taste. Upon returning to CA, tested positive again Feb. 1st and was diagnosed as a "long-hauler". Denies any symptoms at this time except for loss of taste. Approximately 10 minutes after injection in monitoring area, patient began complaining of dizziness, headache, nausea and feeling hot. After about 10 minutes more, patient then began complaining about chills and stated she felt the need to throw up, spit up a small amount of sputum. Offered to call for ambulance, patient stated she did not want to go to the hospital, just wanted to go home. Approximately 10 minutes later, patient felt stable enough move her to a wheelchair and assisted outside so that she could remove her mask. 02 applied at 2L via nasal cannula, patient stated immediate relief of nausea and dizziness once outside. After another 10 minutes, patient stated headache was now a dull ache and she felt well enough to go home. Spouse provided nurse call number for local hospital, patient transported to vehicle via wheelchair.
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| 67 | 2021-02-14 | pain in extremity |
I had no adverse reactions the first three days after receiving the Pfizer COVID-19 vaccination (fir...
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I had no adverse reactions the first three days after receiving the Pfizer COVID-19 vaccination (first dose), except for a sore arm. On day four at 3pm in the afternoon I broke out in a rash in between and under my breasts, which I treated with Clobetasol cream, and the rash got better. At 3 am in the morning I broke out in severe hives (welts) on both sides of my abdomen (more pronounced on my left side), under my abdomen and in my groin area. Those areas were very red, raised, itchy and warm to touch. I did not experience any shortness of breath, swelling of face or throat, or fast heart rate. There were no changes in my diet, medications, laundry detergent, or bath soap. I took Benadryl (25 mg) at 3 am and again at 4 am because there was not much improvement. At 9 am that morning the hives were still present but less red and raised, and not itchy. I took another Benadryl (25 mg) in the afternoon because the hives had not completely vanished.
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| 67 | 2021-02-14 | weakness | Myalgias, fatigue, headache, weakness, nausea, chills, decreased appetite and easy bruising. |
| 67 | 2021-02-14 | weakness |
Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 10...
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Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 100 degrees ( normal temperature is 97.5) 6pm - 6:00 am. Fever spiking to 102.7 throughout night Sunday, 2/14/21 Fatigue and weakness. Increased pain at injection sight.
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| 67 | 2021-02-14 | feeling cold |
The 2nd dose was received on 06-02-21. The next day I had muscle pain and intense cold. Two days lat...
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The 2nd dose was received on 06-02-21. The next day I had muscle pain and intense cold. Two days later I got a rash on my vaccinated arm. Five days later, my body gradually filled with a rash and itching that appeared first on the chest, then neck and face, then on the back and abdomen and went down to the thighs and finally on the feet and soles of the hands. Yesterday 02-14-21 I went to the emergency service at Hospital, after being examined, the diagnosis was an allergic reaction to the vaccine I was prescribed a steroid and anti-allergy. Today is the ninth day after receiving the 2nd dose of the vaccine and I still get the rash and itchy
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| 67 | 2021-02-15 | facial paralysis, bell's palsy | HEADACHE, BODY PAIN FIRST THREE DAYS; DAY FIVE: BELL PALSY-PARTIALFACIAL DROP |
| 67 | 2021-02-15 | weakness | High heart rate, hard to breath, shivers, sore at injection site and general weak feeling |
| 67 | 2021-02-15 | numbness |
Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diap...
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Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diaphoretic. Cold packs applied. (BG = 126, BP180/100, T 97.2, HR 60, R 18, 18:16 time O2 was 94% room air, EKG Normal Sinus Rhythm Alert and Oriented. Repeat BP 98/78. Patient taken to ER or Clinic for further observation unknown if was a ER or clinic
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| 67 | 2021-02-16 | tingling |
One and a half hours after I received my injection, while driving home, my mouth, lips and face bega...
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One and a half hours after I received my injection, while driving home, my mouth, lips and face began to tingle. This lasted for almost two hours. I experienced some brief tingling of the skin on my chest as well and on the skin of my upper thighs. I did not have trouble breathing, and did not develop a rash anywhere on my body. The tingling remained localized to my face and the upper part of my mouth. There was no swelling of my lips or redness of my lips. Immediately after I received my injection I briefly felt the slightest bit of light headedness, but this resolved before I left the vaccination site. I felt tired later in the evening and then began to experience headache and nausea, the typical side effects that I had anticipated and previously heard about.
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| 67 | 2021-02-16 | tenderness | Red swollen indurated tender arm.. itches |
| 67 | 2021-02-16 | weakness | Very weak, fever 39.9, chills for three days |
| 67 | 2021-02-21 | tremor |
34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00...
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34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00 a.m. I was dizzy and had uncontrollable shaking over entire body for approximately 45 minutes. The nausea continued throughout the entire day on 2/19/21. I contacted the Department of Health today, but whomever I spoke to did not seem interesed in hearing about it and did not ask any questions or for any information.
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| 67 | 2021-02-21 | inability to speak, weakness, tingling |
I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was ful...
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I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was full, so my husband and I were standing. I stand and work every day, so this was not difficult. I texted my daughter, who is a hospital employee, and told her that we had a super experience with no wait and had already received our 2nd dose. However, 5 to 7 minutes after the injection, I SUDDENLY felt dizzy and weak and had to sit down. Within a minute or so, I could not stand or open my eyes. The weakness made it difficult to breath or talk. My husband had to lift me up into a wheelchair. I was taken to the ER. For the longest time, I could not even open my eyes or talk above a whisper. After 4 hours, I was able to get my eyes open and talk better. I, gradually, was able to move my hands and feet. Last of all, I could move my hips and walk. It was as if my body had been put to sleep. I could feel everything but my body wouldn?t move. As it wore off, my face and limbs felt slightly tingly. I was, basically, fine after 5 hours other than being tired from the experience. The doctors had no explanation for what happened and said it must be an emotional response to getting the shot. They wrote that I was not exerting enough effort to move my body. One said that I was hyperventilating when I pulled my mask up to breathe after he told me to hold my leg in the air. Though I tried, I was too weak to hold my leg up and it fell to the bed. The doctor told me that I should not tell anyone about what had happened or people would not come to get the Covid vaccination. He obviously knew that SOMETHING had happened that I couldn't control but he didn't put that in his report!
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| 67 | 2021-02-21 | discomfort |
Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at ...
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Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at about 5 pm and 9 pm that day. Also the next morning at 7:30 am and 10:15 am but gone by 4 pm when I am writing this up. No pain on urination. Some discomfort inside. Had general and ob/gyn check up already scheduled for tomorrow at 8 am.
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| 67 | 2021-02-22 | numbness, tingling, pain in extremity |
I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I...
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I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I had pain around the base of my thumb on my left hand.
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| 67 | 2021-02-22 | tingling |
Patient developed tingling throughout her left arm and hand shortly after injection. She denied any ...
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Patient developed tingling throughout her left arm and hand shortly after injection. She denied any strength or sensation deficits. She reported that the symptoms were relatively minor but were not improving. She was encouraged to follow up with her PCP.
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| 67 | 2021-02-22 | speech disorder |
The patient became acutely short of breath and was unable to speak momentarily. She was waiting the ...
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The patient became acutely short of breath and was unable to speak momentarily. She was waiting the requisite 15 minutes and once we evaluated her she was administered an Epi-pen immediately. In a few minutes, her breathing returned to her baseline and she was able to speak in full sentences. Clinically, her BP was stable and she was not tachycardia. Pulses were strong. Also, given 25 mg Benadryl at the time. She
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| 67 | 2021-02-23 | night sweats |
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee...
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2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
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| 67 | 2021-02-23 | weakness |
Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. P...
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Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. Patient monitored for 30 minutes by EMS, VSS, lung sounds clear, SPO2 100%. Patient remained on-site for an additional 15 minutes then went home.
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| 67 | 2021-02-23 | feeling hot, weakness |
Pt. at 9:05 am at observation line was having weakness of the body, dizziness and felt a heat flash ...
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Pt. at 9:05 am at observation line was having weakness of the body, dizziness and felt a heat flash over her body. Paramedics assessed pt. once symptoms subsided the paramedics let pt. leave tent 1.
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| 67 | 2021-02-24 | feeling hot |
Because of all of my allergies I took 25 milligrams of benadryl 30 minutes prior to the vaccine in...
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Because of all of my allergies I took 25 milligrams of benadryl 30 minutes prior to the vaccine injection. Just a few minutes less than an hour after vaccine injection, my face turned beet red and got flaming hot. After 40 minutes of a red, hot face I took another 25 milligrams of benadryl. Now two hours and 40 minutes later my face is much less red and much less hot.
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| 67 | 2021-02-24 | pain in extremity |
Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetamino...
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Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetaminophen. Having a slow recovery. Today, 4th day after the vaccination with second dose still have pain but is lower.
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| 67 | 2021-02-25 | tremor, feeling hot |
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien...
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Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
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| 67 | 2021-02-25 | sensory loss, tingling | tingling hands/fingers, loss of sensation and then peeling skin on palm /in between fingers |
| 67 | 2021-02-26 | tremor |
Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake,...
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Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake, transported to gurney and obtained vitals, pt with O2 Sat 70%, HR 88, administered one dose of epinephrine, placed 10L of O2 via facemask, pt began speaking, was alert and oriented to name and place, continued to report tightness of the chest and itching, called EMS, continued to monitor vitals, and patient transferred to ER without incident.
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| 67 | 2021-02-27 | numbness and pain in extremities | Severe ulnar nerve neuropathy. Could not move LUE for 2-3 days due to pain. |
| 67 | 2021-02-27 | pain in extremity |
Sore arm the first couple of days. After about 7 to 10 days I started feeling sort of dizzy. Equi...
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Sore arm the first couple of days. After about 7 to 10 days I started feeling sort of dizzy. Equilibrium is a little off. Sometimes vertigo. (maybe 3 episodes of vertigo)
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| 67 | 2021-02-27 | weakness |
Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fe...
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Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fever, headache, muscle/joint pain, nausea, dizziness with made it difficult to walk to the bathroom d/t the dizziness, general unwell feeling. I took tylenol. I applied ice packs to my neck and core body area. I was confined to the bed until Friday apprx 11:00 am until I could get up. I continue to feel "funny" in the head at times. I did not seek any Dr or hospital visit.
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| 67 | 2021-02-28 | tingling |
About six hours after the injection I experienced discomfort in my throat, mild swelling in both han...
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About six hours after the injection I experienced discomfort in my throat, mild swelling in both hands and face, some tingling in face, and head ache.I took Zyrtec 10 mg, Pepcid AC 20mg. Then I started to have tightness in my chest and used my albuterol inhaler. I was still having symptoms an hour later so took Benadryl 25 mg. During the night I woke up with mild wheezing and used my inhaler again. Throughout the next 2 days, I continued to have these symptoms (except for wheezing) off and on. Today, I still have some symptoms but not as often or severe.
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| 67 | 2021-02-28 | feeling hot |
I received the vaccine at approximately 1 p.m. in my left arm. I informed the technician that I ha...
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I received the vaccine at approximately 1 p.m. in my left arm. I informed the technician that I had allergies and had previously had anaphylaxtic reactions to foods and some medications. I had noticed that the Pharmacy was not requiring people to stay after receiving the vaccine, so I told the technician that I would stay until I was sure I did not have a reaction. No one came to check on me, and in about 15 minutes, I noticed that my scalp was starting to itch and my face felt hot. I decided to go home, which was only a 5 minute drive from the store. I took off my mask in the car and discovered that my face was very red and starting to feel tight. I got home and took 1 Benadryl pill. By the time I got home, around 1:25 my ears were itchy and my lips were starting to swell. I waited an hour and started to feel better, the color in my face was returning to normal, and I had no swelling of my throat, which I have experienced with food allergies. At hour 2 I took a second Benadryl and went to sleep for 2-3 hours. When I woke up, I felt better, my lips were still slightly swollen, but my face, scalp and ears were back to normal.
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| 67 | 2021-02-28 | pain in extremity |
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid...
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Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 67 | 2021-02-28 | tingling |
Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Bena...
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Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Benadryl was given and patient was observed for an hour and stated she felt better when she left. Patient was not driving the car.
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| 67 | 2021-02-28 | burning sensation | RASH ON FACE AND NECK WITH BURNING AND STINGING. SWELLING OF FACE AND EYES. |
| 67 | 2021-02-28 | tingling, tremor |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient felt faint, blood pressure dropped and 911 was called. pt's spouse informed us after the vaccination that she has this reaction with all vaccinations due to a branch block. paramedics cleared patient to leave after observation period.
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| 67 | 2021-03-01 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable Consumer. This 66-year-old female con...
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Bell's Palsy; This is a spontaneous report from a contactable Consumer. This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.
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| 67 | 2021-03-01 | weakness |
Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder cap...
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Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder capsule and right ankle, 101 degree fever lasting 6 hours Day 2: chills, exhaustion/weakness, inability to concentrate, lack of appetite Day 3 &4: waves of muscle aches and exhaustion
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| 67 | 2021-03-01 | numbness |
upon injection, arm become numb. After a few minutes, left side of face was numb and still conti...
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upon injection, arm become numb. After a few minutes, left side of face was numb and still continues to be a week later. Went to doctor yesterday and she said all the vitals are good.
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| 67 | 2021-03-02 | migraine |
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5...
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Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
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| 67 | 2021-03-02 | pain in extremity |
Mild pain upper right arm/shoulder/neck immediately after receiving vaccination. Pain worse next day...
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Mild pain upper right arm/shoulder/neck immediately after receiving vaccination. Pain worse next day. Arm/shoulder pain resolved within a few days, neck pain persists - has not resolved. Also developed swollen lymph node right side of neck 1 day after vaccination which remains swollen. Saw FNP in regular provider office 2/04/21, no treatment recommended. Episode of benign positional vertigo 1/21/21. No history of this, FNP thought it could have been related to vaccination. Severe vertigo resolved after treatment, still have occasional mild vertigo episodes.
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| 67 | 2021-03-02 | tingling |
One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for tw...
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One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours.; One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs.; very light headed right after the shot; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261, expiry date: not reported), via an unspecified route of administration at left arm on 29Jan2021 12:45 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, gastrooesophageal reflux disease (GERD), and migraine. The patient also had known allergies to multiple antibiotics, kiwi, walnuts, and bee sting. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]), topiramate, vitamin D3, guaifenesin (MUCINEX), and clarithromycin (CLARITIC). The patient stated, "One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs. I had no trouble breathing. I was also very light headed right after the shot but that resolved quickly." All the events started on 29Jan2021 14:15 (reported as 02:15 PM). There was no treatment received for all the events. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient recovered from all the events.
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| 67 | 2021-03-02 | numbness |
face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a c...
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face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date. The patient, on 16Feb2021 had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.
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| 67 | 2021-03-02 | feeling hot | heat and redness throughout entire face |
| 67 | 2021-03-02 | migraine |
throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (...
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throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
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| 67 | 2021-03-03 | pain in extremity |
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded...
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3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded range between 59 and 166. 3/4 - itchy rash near injection site ( have photo)
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| 67 | 2021-03-03 | bell's palsy, speech disorder |
Bell's palsy; She cannot talk real well right now; This is a spontaneous report from a contactable c...
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Bell's palsy; She cannot talk real well right now; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6200, unknown expiration), via an unspecified route of administration in right arm on 16Feb2021 at 10:55 at a single dose for COVID-19 immunisation in a hospital. Medical history included chickenpox and measles (when she was a kid), COVID-19 in 2020 (last year), ongoing anxiety, ongoing blood pressure (abnormal), and ongoing insomnia. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEXA), and ongoing unspecified anxiety, blood pressure and insomnia medications. The patient received her first dose of BNT162B2 (lot number: EJ1686, unknown expiration) on 20Jan2021 at 11:33 in right arm for COVID-19 immunization. The patient's friend called on behalf of the patient because she cannot talk real well right now (Feb2021). The patient's friend confirmed that the patient went to emergency department and was told that she has Bell's palsy on 18Feb2021 at 14:00 and she has never had it before, and they did not know if it was a side effect from the COVID-19 vaccine or not. The patient received prednisone 20mg 3 times a day, Valpex, antibiotic, and eye drops for right eye as treatments. Blood test was taken on 18Feb2021 with unknown result. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-03 | pain in extremity, cold extremities, flushing |
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t...
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Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
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| 67 | 2021-03-03 | feeling hot |
Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a ...
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Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included "thyroid," high blood pressure, depression, anxiety, and osteoporosis. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. It was unknown if the patient had any allergies to medications, food, or other products. The patient received unspecified concomitant medications. The patient did not receive any pother vaccines within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced left arm red, hot, and raised at first. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of left arm raised was recovered. The outcomes of left arm hot and red was not recovered; left arm was still red and hot and it was day 12. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-03-03 | pain in extremity |
Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doe...
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Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doesn?t go down,
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| 67 | 2021-03-03 | pain in extremity |
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes a...
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Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8. It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
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| 67 | 2021-03-04 | numbness, tingling |
Experience tingling, then numbness in my hand then it went to my face which was a hardness and tingl...
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Experience tingling, then numbness in my hand then it went to my face which was a hardness and tingling or needles & pins in my lip, it was on the left side, the same side as the injection and started to subside after an hour and a half to 2 hours, defined a strange wierd feeling which I still very slightly feel.
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| 67 | 2021-03-05 | pain in extremity |
1. Sore Arm the next day. Expected because the first shot made the same arm a little sore. 2. Low...
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1. Sore Arm the next day. Expected because the first shot made the same arm a little sore. 2. Low Grade Fever and Chills. (can't take anything else due to PE caused by DVT.) 3. Light cough. Not a sore throat but not right. 4. Terrible headaches. But Tylenol takes it away in time. 5. All over Achy body. What is most concerning is the oxygen level Because of my PE I watch my levels at night. Average for me with PE I'm around 94-97 saturation But from Wednesday Night March 3 my levels are lower. Dropping to 88-85. My finger montor goes off at 88 so I cake a couple of deep breaths to bring it back up.
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| 67 | 2021-03-05 | weakness |
After 30 minute observation after vaccination per protocol for anaphylaxis history, patient left uni...
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After 30 minute observation after vaccination per protocol for anaphylaxis history, patient left unit at 5:55pm and as she was leaving facility she reported symptoms to staff of "high blood pressure", "faintness", dizziness, lightheaded, weakness per patient--patient was assessed by EMS on site and BG was 86, BP elevated at 161/76. After further observation but no significant progression or improvement of symptoms she agreed to be transported to ED at 6:30pm.. No medications given on site, juice and crackers provided for low BG and report of missing meal,
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| 67 | 2021-03-05 | pain in extremity | Right ankle and mid-lower tibia pain (sharp). Pain moved to toes. BP 141/76 (pulse 95). |
| 67 | 2021-03-06 | pain in extremity |
An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and ch...
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An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and chills for about 6 hours. It was tolerable and manageable with Ibuprofen and lots of water.
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| 67 | 2021-03-06 | difficulty speaking |
At 30 min observation time pt. Advised medics that she had hoarseness and scratchy throat. Medics i...
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At 30 min observation time pt. Advised medics that she had hoarseness and scratchy throat. Medics in obs. lot did initial eval, and FIre/Rescue EMS summonsed (SMFRA) via 911 for potential allergic/anaphylactic reaction. Vital signs were BP 180/100, P82, Pox99% on RA and R20. Pt was evaluated also by fire/EMS and patient encouraged to seek medical attention via ambulance. Pt. refused transport to facility but agree to go POV. Pt. had total time pre obs/post obs of approx one hour with no worsening of s/s. Pt. was release AMA with advisement of not seeking medical attention could lead up to death. Pt. accepted risks. Pt. also advised to advise PCP.
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| 67 | 2021-03-06 | pain in extremity |
Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever S...
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Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever Severe chills Left arm pain Injection site swelling, redness hives around left upper arm Left axillary lymph node swelling
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| 67 | 2021-03-07 | feeling cold, weakness, feeling hot, tingling |
About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very ...
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About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very hot. Then tingling went all over my body, even in my lips. At one point, I felt close to fainting. The pharmacist lady gave me cold water (I asked for it), and I just sat there for quite a while. Gradually my heart rate came down, and I got cold, but the tingling kept going, and I felt somewhat weak. Since I didn't want any epinephrine (it affects my heart), and I didn't think I was so bad that I needed an ambulance, after being there nearly an hour my husband drove me home. There I took some liquid Benadryl, and that seemed to help with the tingling. I just took it easy after that. Considering my reaction tothe first dose, I will NOT be getting the second one. I don't need to consult with a doctor to decide that. It was somewhat frightening because I didn't know how bad it was going to get.
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| 67 | 2021-03-07 | pain in extremity |
Extreme chills, aches body and head, swollen lymph node in left arm. Very sore left arm and difficu...
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Extreme chills, aches body and head, swollen lymph node in left arm. Very sore left arm and difficulty lifting it. Fatigue. LARGE RED CIRCLE ON UPPER LEFT ARM NEXT TO INJECTION SITE. The red spot is warm and tender and has persisted for 3 days.
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| 67 | 2021-03-07 | numbness, tingling |
c/o feeling "foggy" and left hand tinging and numbness 30 minutes after dose(1040 am).. Pt took own...
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c/o feeling "foggy" and left hand tinging and numbness 30 minutes after dose(1040 am).. Pt took own Benadryl tablets(2) BP 189/90, HR 55 Speech clear, A & O x 4. . 15 minutes later (1055), c/o "tongue swelling" and took another Benadryl tablet. No swelling observed, speech clear, no airway impairment. BP 170/90, HR 54, oxygen saturation 98%. 1110, c/o left thumb feeling "numb". 1120, tongue swelling sensation resolved. 1130, patient ambulated with RN, took additional Benadryl tablet. Stated hand numbness was resolving. "I'm going to be okay". 1155, pt escorted to vehicle.
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| 67 | 2021-03-08 | muscle spasms |
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra...
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Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
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| 67 | 2021-03-08 | cold sweat |
Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to...
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Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to the floor and her blood pressure was taken, at 104/85. She was sweaty and clammy. Patient stated that she was anxious about the vaccine and something like this had happened before. After laying on the floor she felt better and soon after sat up in her chair. Her blood pressure was taken again and rose to 133/66. She was observed in the waiting area and started feeling better after 15 minutes.
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| 67 | 2021-03-08 | pain in extremity, numbness and pain in extremities |
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremi...
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Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
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| 67 | 2021-03-08 | migraine |
migraine next 2 following days after shot. Tiredness the day of the shot and the following day. Col...
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migraine next 2 following days after shot. Tiredness the day of the shot and the following day. Cold/allergy symptoms including nasal sinus congestion and runny nose all the way up until today. Also paying on the side of injection on the day of the shot and following day
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| 67 | 2021-03-08 | tingling |
vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needle...
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vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needles effects Friday 8:00 PM to Saturday 10:00 rash continues but not as severe to currently Tuesday at noon Jaundice, elevated liver enzymes, and elevated billirubin started Saturday to currently Tuesday at noon
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| 67 | 2021-03-09 | pain in extremity | Left arm pain itching, redness and swelling approx. 6cm/3cm. |
| 67 | 2021-03-09 | numbness |
after about 5-6 hrs left side of my face became partially numb/feels like a hand is on my face/ Now ...
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after about 5-6 hrs left side of my face became partially numb/feels like a hand is on my face/ Now been 4 days and still somewhat numb; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 03Feb2021 09:00 am at SINGLE DOSE for covid-19 immunisation. Medical history included sjogren's syndrome, allergies to sulfa. The patient's concomitant medications were not reported. It is reported on 03Feb2021 02:00 PM, about 5-6 hours after the vaccination, left side of patient face became partially numb. Everything functions fine but feels like a hand is on her face. Went to doctor who couldn't find anything else wrong and encouraged her to still get second shot. Now been 4 days and still somewhat numb, possible getting better but hard to tell. No treatment received for the events. Outcome of the event was not recovered. The patient is not pregnant. No covid prior vaccination. No covid tested post vaccination.
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| 67 | 2021-03-10 | feeling hot |
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills...
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syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-11 | pain in extremity |
Approximately 18 to 20 hours after my injection, my left arm developed a red and swollen rash in a c...
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Approximately 18 to 20 hours after my injection, my left arm developed a red and swollen rash in a circular shape approximately 3.5 cm in diameter. The circular area was very sensitive and painful. My upper arm was also sore, although not severely. On day 3 or 4 post-injection, the red circular area remained the same in size but seemed less swollen. Although sensitive, it was no longer painful. However, it is now day 8 post-injection and the circle remains the same size and color.
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| 67 | 2021-03-11 | unresponsive to stimuli, tremor |
Patient received Pfizer vaccine at 0657 into the left deltoid. Vaccinator notified on-site provider...
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Patient received Pfizer vaccine at 0657 into the left deltoid. Vaccinator notified on-site provider (this writer). Patient was very slow to communicate and was slumped back in chair with a slight tremor noted to right hand. I notified charge nurse to call 911 and returned to the vaccine station. At this time, patient was slumped back in chair, non-responsive and agonal breathing. Sternal rub was performed without any response. Carotid pulse palpated. Patient then received 0.3 mg Epinephrine injection via epipen into her left thigh. Patient was then assisted from the chair to the floor by this writer and vaccinator. Vital signs obtained: BP 122/78, HR 71, RR 22, T 97.4, O2 96%. Patient was again sternal rubbed with very minimal response. 2 liters oxygen applied via NC. Repeat Vitals: 110/70, HR 71, 93% on 2 liters via nasal cannula. . EMS arrived and patient was coherent, talking, and alert/oriented x3. Patient was helped to sit and was able to sit without difficulty. Patient encouraged to be transported to ER for evaluation. Patient ambulated to ambulance stretcher and was taken to ambulance for transfer.
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| 67 | 2021-03-11 | numbness |
right sided facial numbness that started same night of vaccination about 8-9 hours after, lethargy t...
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right sided facial numbness that started same night of vaccination about 8-9 hours after, lethargy that started right away
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| 67 | 2021-03-12 | pain in extremity | 7 days after the shot, my right arm started getting itchy, swollen, sore and red. |
| 67 | 2021-03-12 | pain in extremity |
Severe pain in left arm, unable to raise arm or lift anything. Sudden, profuse diarrhea unlike anyth...
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Severe pain in left arm, unable to raise arm or lift anything. Sudden, profuse diarrhea unlike anything I've ever experienced (about 6 hours after shot).
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| 67 | 2021-03-12 | feeling hot |
Suddden onset of feeling very hot in my face and neck.. I went to bathroom and looked at my face n...
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Suddden onset of feeling very hot in my face and neck.. I went to bathroom and looked at my face no swelling noted. My neck had a pouch of fluid accumulating with small redden areas on my neck and upper chest area. No other symptoms noted. My breathing was good.
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| 67 | 2021-03-12 | tenderness |
redness in the arm that spread after one day to the whole body and remained for more than a week as ...
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redness in the arm that spread after one day to the whole body and remained for more than a week as per patient, sensitive to the touch.
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| 67 | 2021-03-13 | feeling cold | Extreme chills, nausea, about 2 hours |
| 67 | 2021-03-13 | weakness | Low grade fever, chills, headache, tires, weak |
| 67 | 2021-03-14 | facial pain |
A rash on my forehead and that spread around the right eye for next two days; Developed pain on righ...
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A rash on my forehead and that spread around the right eye for next two days; Developed pain on right side of face; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration on Right arm on 21Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included Allergies to Sulfa and Osteopenia/osteoarthritis. The patient's concomitant medications were not reported. The patient reported, On 28Jan2021, one week after receiving the Covid vaccine, I developed pain on right side of face. On 31Jan2021 I developed a rash on my forehead and that spread around the right eye for next two days. The Dr was contacted on 02Feb2021 and I started on Valtrex (Valacyclovir HCL, 1 Gm, 3 times a day on 28Jan2021 13:00 upon Doctor or other healthcare professional office/clinic visit). The patient received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovering. Information on the lot/batch number has been requested.
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| 67 | 2021-03-14 | numbness, tingling |
Left eye itching, pain-Like a "pink eye" - sxs worsened by Sunday Today numb left jaw-like feeling l...
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Left eye itching, pain-Like a "pink eye" - sxs worsened by Sunday Today numb left jaw-like feeling like the dentist applying novacaine, Lt leg & fingers to Lt hand tingling, pins & needles. Used teabags to Tx eyes with minimal relief.
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| 67 | 2021-03-14 | pain in extremity |
My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling wel...
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My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling well; felt feverish; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on her arm on 25Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included raynaud's phenomenon. She was told that she could not donate plasma because of it but she have raynauds, she stated she is not taking medications or anything for it, it's just she get chills in her hands and feet from anything if she drink anything cold or get chilled or whatever, white they turn white. It was reported that patient had Covid 19 and was tested positive for antibodies back in June. The patient's concomitant medications included estradiol (Cream, its a hormone cream), vaginally at 13 micro grams, twice a week for unknown indication and acyclovir for unknown indication. In Jan2021, patient reported that her arm did get sore and it had stayed sore and she is also experiencing nausea, she had experienced nausea that night, a headache, not feeling well and felt feverish didn't recorded fever but her concern is that it's not going away. The patient received treatment just advil (as reported). The events were considered as non-serious. The outcome of the event felt feverish was not recovered and outcome of other events unknown.
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| 67 | 2021-03-14 | pain in extremity | Nausea muscle aches chills very painful left arm |
| 67 | 2021-03-14 | pain in extremity |
nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontan...
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nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
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| 67 | 2021-03-15 | pain in extremity |
1st Pfizer vaccine on Wed 3/3 morning. Saturday morning started noticing ache in right lower leg th...
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1st Pfizer vaccine on Wed 3/3 morning. Saturday morning started noticing ache in right lower leg that did not feel neurological. It was more achy when putting my weight on it. It continued on Sunday and finally stopped on Monday. I was unable to make an appointment with my GP until 3/29 and I have an appointment with my gynecologist 3/25. My 2nd dose is scheduled for 3/24 10:30 and I would prefer to postpone the 2nd dose until I meet with my 2 doctors if possible. I was concerned it might be related to the hormones so I stopped the Estriol 3/6/21 and my leg was back to normal on 3/8/21.
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| 67 | 2021-03-15 | weakness, burning sensation |
Arm has been burning for 2 2/2 weeks. The injection was given up high. Also woke up with nausea whi...
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Arm has been burning for 2 2/2 weeks. The injection was given up high. Also woke up with nausea which has lasted over a week. Spent first day after injection in bed. Felt feverish and had absolutely no energy. Felt that way for about two or three days. For about a week had very little energy. My arm through the shoulder blade and in the back still has a burning sensation.
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| 67 | 2021-03-15 | difficulty speaking |
BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous re...
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BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel "like her throat was closing up". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, "I feel like my throat is closing up". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling "some better". HR 76, SpO2 97%, BP 106/66; reported "chest feeling tight". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-15 | involuntary muscle movements, numbness, muscle spasms, sensory loss |
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i...
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Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
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| 67 | 2021-03-15 | night sweats | Rash around face, night sweats. |
| 67 | 2021-03-15 | feeling hot, pain in extremity |
Sore arm for the rest of the day after receiving the shot. On 2/27 fatigue. On 3/4 possible low gr...
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Sore arm for the rest of the day after receiving the shot. On 2/27 fatigue. On 3/4 possible low grade temperature with periods of feeling very warm and sweating. Lasted approximately an hour. On 3/6 again periods of feeling warm and sweating. Rotating achiness in muscles. Brief feelings of discomfort in axillary region but unable to palpate lymph node. Lasted half the day. On 3/14 headache across the front of my face above my eyes with left side neck discomfort. On 3/15 again experienced periods of warmth and sweating throughout the day. In between headache, Not as severe as headache on 3/14. Contacted doctor by email.
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| 67 | 2021-03-15 | pain in extremity |
pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating...
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pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating; could barely walk; The pain in my foot became excruciating; could barely walk; This is a spontaneous report from a contactable Consumer (patient). A 67-year-old female patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EL9263), via an unspecified route of administration in right arm on 19Feb2021 09:30 AM at single dose for COVID-19 immunization. Medical history included known allergies to Sulfites, Iodine as contrast, Dairy, Gluten. Concomitant medication included levothyroxine, liothyronine (NP THYROID), latanoprost (LATANOPROST) and Supplements (Other medications in two weeks). The patient was not pregnant. The patient did not have COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= COVID-19 immunization), via an unspecified route of administration in right arm on 29Jan2021 11:30 AM at single dose for COVID-19 immunization. The patient did not have other vaccine in four weeks. 19Feb2021 after 2nd shot: pinching all over body and mildly nauseated. Plantar fasciitis left foot had no pain for 24 hours. 24 hours later: no nausea. The pain in the foot became excruciating; could barely walk. Lasted 2 days. Milder now. Adverse event start date was 19Feb2021 10:30 AM. The outcome of the events was recovering.
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| 67 | 2021-03-16 | pain in extremity |
I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the ...
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I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the pharmacist contacted me telling me I had only received a saline solution and would need to get vaccinated again. I inquired how they knew this and received sparse information saying they couldn't tell me ... privacy etc. Then on March 10th I went to another one of their locations and received the first vaccine of Moderna ... I have been super sick since then.. I have had fever, delirium, cognitive impairment ( forget vocabulary MID sentence) severe covid arm, ( worse than the images on line) pain in my left hand, stiffness in my left fingers ( what I assume arthritis might be like) I WANT TO KNOW what WAS IN THE FIRST PFIZER INJECTION: I AM DEMANDING... to find out what was in the first shot, why it was reported to me 4 days later, How the facility knew it was only saline... WAS it TRULY ONLY SALINE or have I been injected with two different doses of vaccines within a 9 day period? I really need to know what it going on.
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| 67 | 2021-03-17 | tremor |
3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiti...
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3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiting every hour - 7 hours and off and on the next 48 hours 3/15/21: 10:00 am extreme joint pain 48 hours 3/15/21: 10:00 am headache off and on 72 hours 3/16/21: 3:00 am 102.4 temperature (couple of hours?)16 3/16/21: 12:00 pm sore throat 24 hours 3/16/21: Fatigue Continues 3/16/21: Very dizzy 3/17/21: 3:00 pm injection side tenderness and slight swelling 48 hours 3/18/21: 3:00 pm first time able to get out of bead and shower - slight light headedness
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| 67 | 2021-03-17 | weakness |
About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up...
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About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up about 9am the next morning I was dizzy and then fainted. The fever persisted until mid afternoon that day, as did the body aches, and a headache. I spent the day dozing or sleeping. I did eat some oatmeal and have a cup of black coffee about noon. That helped the headache. That evening I was more tired than usual, but no fever or aches. The next day I was also very tired, but I did go to work. The rest of the week I had no energy, but that was the only other side effect. After the first shot, I had only had an achy arm at the injection site that persisted for 2 or 3 days.
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| 67 | 2021-03-17 | weakness | Fever, headache, weakness, malaise, muscle aches |
| 67 | 2021-03-17 | tingling, pain in extremity |
Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the ...
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Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the arm and shoulder into the neck area. Tingling in thumb and 3 fingers. Never have had any issues like this. Went to Orthopedic doctor who found arthritis in neck. Given Prednesone but did not help at all. Called doctor again and asked if tingling in hands was associated with arthritis and told not normally and what else I could do? Suggested an MRI which did not have yet. Pain is diminished today but tends to flare up. Pain is worse at night. Never had any symptoms like these before the 2nd Covid shot.
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| 67 | 2021-03-17 | migraine | Migraine, chills, nausea, dizziness, fever |
| 67 | 2021-03-17 | numbness |
My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-o...
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My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, in the left arm, on16Feb2021 at 10:15 (at the age of 67 years-old) as a single dose for covid-19 immunisation. Medical history included headache, anaphylaxis reactions to food allergies, Spinich, cabbage, sulfa based drugs diabetes, and asthma. The patient had not received any other vaccinations within 4 weeks and was not diagnosed with COVID-19. Concomitant medication included diabetes meds and insulin glargine (BASAGLAR). The patient reported on 16Feb2021, at 10:45 after waiting 30 as instructed, I had a reaction 5 - 10 minutes later. My face went numb, and then a headache started. I have had only 1headache in my life prior to this. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the event was recovered
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| 67 | 2021-03-18 | muscle spasms, migraine |
1AM Sat. March 6: Woke up shivering, lasted on and off throughout the day) Also had a Severe migra...
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1AM Sat. March 6: Woke up shivering, lasted on and off throughout the day) Also had a Severe migraine, severe nausea, lower leg cramps, and vomited 5 times until nearly 5PM ( last 3 times was water that was sipped but "heaved") mild diarrhea. Family offered to take me to hospital at since I had trouble "holding down" sips of water. Dozed off about 11PM and woke up at 1AM feeling better. Nausea and headache had subsided greatly, Congestion lasted until Sat. Took a 24 hour non drowsy Sudafed on Thursday and Friday. Rested Sunday and ate very light (toast; applesauce).
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| 67 | 2021-03-18 | pain in extremity, discomfort |
9pm pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radia...
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9pm pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radiating up into neck; swelling to right side of neck; pain radiating down to hand with pain in first two knuckles; swelling noted to axillary area; pressure moving to 1st and second rib from shoulder; feeling of fullness in right arm and shoulder; difficulty move arm and hand grasp affected.
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| 67 | 2021-03-18 | burning sensation |
Approximately 2 hours after receiving vaccine, patient states her back started burning and she broke...
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Approximately 2 hours after receiving vaccine, patient states her back started burning and she broke out in hive on back and both arms. She self-treated with benadryl for duration of hive (2 days).
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| 67 | 2021-03-18 | numbness, tingling |
Approximately 20min prior to admin of 1st dose of vaccine, patient developed tingling and numbness s...
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Approximately 20min prior to admin of 1st dose of vaccine, patient developed tingling and numbness sensation of lips. Over the course of 3min this tingling and numbness sensation progressed to the left side of her face and the left side of her tongue. 0.3mg of epinephrine was administered via autoinjector 3min following onset of s/s. 50mg PO diphenhydramine was administered 5min following onset of s/s. Pt developed no further s/s, No: rash, pruritus, chest tightness, chest pain, angioedema, abdominal pain, nausea, emesis, dizziness, syncope. VS stable throughout evaluation. Ambulance arrived approximately 10min following onset of s/s and pt was transported to ED for evaluation.
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| 67 | 2021-03-18 | feeling cold |
Day 1 none noted Day 2 extreme overall body aches, headache, fever (101.2) chills. Took Tylenol o...
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Day 1 none noted Day 2 extreme overall body aches, headache, fever (101.2) chills. Took Tylenol one time -30 hrs. after injection Day3 fever and aches began subsiding *now noted itchy, red, hive-like rash, warm to touch- around upper and inner arm around injection site as well as sore and swollen lymph node in armpit of same arm. Took Tylenol 2 times Ice to arm Day 4 fever, aches, headache subsided. Red rash on arm larger, red, itchy, warm and node still sore (no fever) Ice to arm and took 10 mg Cetirizine
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| 67 | 2021-03-18 | feeling hot |
Discussed vaccine ADE after first dose with patient. Pt reports having existing lung disease for whi...
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Discussed vaccine ADE after first dose with patient. Pt reports having existing lung disease for which she uses oxygen and CPAP overnight. She reports feeling fatigued and increased SOB on exertion and increased O2 requirement for 2d after receiving vaccine. She also reports intermittent sweating and feeling hot on her head and scalp but without chills or bodyaches for 3 weeks now. When she checked her temperature at home, she reports temps of 98 or 99. Based on discussion, her reaction is not likely to be an allergic reaction and more likely an immune response to vaccine. Patient agrees to proceed with 2nd dose and will continue to monitor symptoms.
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| 67 | 2021-03-18 | weakness |
Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her a...
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Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.
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| 67 | 2021-03-18 | numbness | NUMBNESS IN UPPER LIP AND NOSE, CHECKED OUT BY EMS AND VITALS TAKEN, MONITORED AND THE RELEASED |
| 67 | 2021-03-18 | flushing |
Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with repor...
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Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with reported history of anaphylaxis. No shortness of breath or chest pain. - Pt given 25mg diphenhydramine - Sxs gradually resolved without further intervention
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| 67 | 2021-03-18 | flushing |
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F...
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Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
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| 67 | 2021-03-18 | pain in extremity |
arm was a little sore; This is a spontaneous report from a contactable nurse (patient). A 68-year-ol...
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arm was a little sore; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 (Lot number was not reported) as single dose, then dose 2 via an unspecified route of administration on 20Jan2021 (Lot number was not reported) as a single dose; both for covid-19 immunisation. Medical history included hypertension. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for hypertension, start and stop date were not reported. Patient had the Pfizer first shot (Covid19 vaccine Pfizer) and her arm was a little sore on an unspecified date and within the second time she got the shot, she rubbed it really hard. It was also mildly sore but neither shot, patient had any feelings of any sort. No side effects whatsoever other than arm. No treatment was given. Outcome of the event was unknown. Information of lot/batch number has been requested.
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| 67 | 2021-03-18 | tremor |
feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nause...
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feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nauseous; accelerated HR; she had body shakes/body was trembling; to the point she thought she was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL1284) at vaccination age of 67-year-old via an unspecified route of administration on 28Jan2021 at a single dose to prevent COVID19 (covid-19 immunisation). Medical history included interstitial lung disease and overactive thyroid (She was treated for overactive thyroid, but it has been stable for five years). Concomitant medication included nitrofurantoin for interstitial lung disease and fluticasone. The patient previously took prednisone [prednisone acetate] (She did ten weeks of Prednisone and has been off Prednisone since the middle of Nov2020. She started at 30mg and tapered down to 20mg then to 10mg and then to 5mg until she was done). The patient experienced feeling lightheaded, mild headache, fatigue, erratic bp 01Feb2021 11:30, feeling nauseous on an unspecified date in 2021. Took Pfizer Covid 19 vaccine last week. Began feeling lightheaded, mild headache, fatigue, erratic BP on Monday, 4 days after receiving the vaccine. Went to Emergency department on Monday evening. Has been continuing off and on since Monday. Can these symptoms occur after 4 days patient questioned. Has already reported to DSU. She got Pfizer's COVID19 Vaccine a week ago today. She was doing fine and then Monday she started with mild headache, erratic blood pressure readings. She ended up in the ER because it was so high. It stabled out and she went home. She was feeling ok on Tuesday, but not quite normal. She was fine yesterday until last night then it started again with erratic blood pressure, fatigue, mild headache and lightheadedness. The headache is never pounding. The lightheadedness won't go away. Is that normal to have that many days after receiving the vaccine? It was four days before she started experiencing it. Now she feels kind of normal as long as she is laying down except for headache. As of 15Feb2021, the patient reported that she called a couple weeks ago and reported adverse side effects and she needed a couple questions answered. She mentioned that she was due to have the second vaccine this weeks (18Feb2021). She was extremely worried about doing it because even some of the effects she had after 4 days in the first vaccination have not subsided. She added that it landed her in emergency room a couple of times (also reported as ended up in the ER twice). She inquired if should she take the second one at this point or can she wait and if she can wait for how long. She mentioned that she had a spike in her blood pressure (BP), she had accelerated HR on an unspecified date in 2021, she was very lightheaded to the point she thought she was going to pass out on an unspecified date in 2021. The second time around, her body was trembling on an unspecified date in 2021, she had body shakes. It was not fun. All of these effects have returned to somewhat normalcy, but she is still experiencing lightheadedness. She has seen her own physicians, but she is not sure if she should proceed with the second vaccine. The outcome of the event lightheadedness was not recovered while the outcome of the other events was recovering. Follow up (15Feb2021): New information received from a contactable consumer (patient) included: lab data, new event (accelerated HR, to the point she thought she was going to pass out, body shakes/trembling) and clinical course of the events.
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| 67 | 2021-03-19 | muscle spasms |
I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an ...
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I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an hour of the shot and became quite fatigued a couple hours later. Approximately 8 hours after injection I began having severe chills with teeth chattering and muscle cramps and aches. which lasted for three exhausting hours. Then suddenly I had a fever of 101 degrees and body aches and nausea with extreme fatigue until 4:00 PM the next day. The fatigue and brain fog continued until 48 hours or so after the shot. My arm did not hurt at all by the way. Nurse had me pull my arm down in an exaggerated way as she gave me the shot and it seems to have helped.
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| 67 | 2021-03-19 | pain in extremity | Nausea headache sore arm |
| 67 | 2021-03-19 | feeling cold |
Patient became diaphoretic and cold 10 minutes after vaccination. Vital signs: BP 170/90 , Repeat a...
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Patient became diaphoretic and cold 10 minutes after vaccination. Vital signs: BP 170/90 , Repeat after 15 mins 165/90 HR 74, SPO2 100% RR 28 She denied chest pain, syncope, difficulty breathing, itching. Preferred to go home, refused offer to be transported to Emergency room.
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| 67 | 2021-03-20 | slurring, weakness |
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu...
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Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
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| 67 | 2021-03-20 | weakness |
Fever 103°, chills, muscle aches, joint pain, headache, difficult breathing, weakness, ringing in e...
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Fever 103°, chills, muscle aches, joint pain, headache, difficult breathing, weakness, ringing in ears
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| 67 | 2021-03-20 | pain in extremity |
Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was ad...
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Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was administered and lasting for about 36 hours. Chills and mild fever starting about 12 hours after the vaccine was administered and lasting about 8 hours.
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| 67 | 2021-03-21 | weakness |
1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically...
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1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically, now daily. 3. Back pain near kidney developed a week after vaccine. 4. Thirsty and for 3 days unquenchable thirst. 5. Had spurts of joint pain all over for several days. Did not have these symptoms with 1st vaccine, this has been progressing for 2 weeks, as of tomorrow, and got worse as time passed. I am very active and healthy and this has certainly impacted my routine. I still work. Visit to Dr. about back pain resulted in negative test and Dr. blamed it on vaccine.
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| 67 | 2021-03-21 | tingling, numbness |
4 days after my first vaccine I started to have numbness, pressure and tingling in my upper lip and ...
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4 days after my first vaccine I started to have numbness, pressure and tingling in my upper lip and lower face, which varies in how uncomfortable it is. I have had sinus issue in the past and some previous issues with facial pressure, but this seems different. I have not previously had this kind of pressure or numbness in my upper lip, lower face, unless I was having an allergic reaction to a medication
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| 67 | 2021-03-21 | pain in extremity |
Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days. Diarrhea...
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Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days. Diarrhea stated at 6:00 am the day after my second shot and lasted 10 days.
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| 67 | 2021-03-21 | pain in extremity |
Pain in arm at the injection site. fever of 100 degrees, sweats and chills, extreme tiredness, tota...
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Pain in arm at the injection site. fever of 100 degrees, sweats and chills, extreme tiredness, total body aches for about 36 hours
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| 67 | 2021-03-21 | tremor |
Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling...
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Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling. She denied any history of diabetes. Patient stated that she has many severe allergies (did not verbalize to what specifically even when asked) and even carries her own epi pen. She acknowledged that this did not feel like an allergic reaction and more like symptoms of anxiety. Patient refused EMS and stated she wanted to wait to see if she could calm down. Second RN and Pharmacist were called for assistance. Pulse ox was placed on patient and O2 Sats ranged from 94-97%, HR 90's. Patient stated she had history of HTN and asked for her BP to be taken d/t her headache. BP was 128/85. After about 20 minutes of close monitoring, patient stated that she was starting to feel better and trembling decreased. Patient remained in observation area for 30 more minutes and left in stable condition after all symptoms had subsided.
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| 67 | 2021-03-21 | nerve pain |
Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also...
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Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also base of left neck. Describes pain as a burning nerve type pain. It is improving with time but not with gabapentin or tylenol. Hx of CRPS
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| 67 | 2021-03-21 | burning sensation, tingling, feeling hot |
right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with bu...
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right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with burning; itching; tingling sensations; felt hot; dizzy; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. The patient had COVID prior vaccination (dates unspecified). The patient was not pregnant at the time of the vaccination and report. The patient's concomitant medications were not reported. The patient had known allergies to aspirin, codeine, metoclopramide, morphine, hydromorphone, tramadol, hydrocodone, and prochloperazine maleate (COMPAZINE). The vaccination was done in the hospital. In Jan2021 (also reported as 18Jan2021), patient experienced right cheek redness and rash with burning, itching, tingling sensations. The patient also felt hot and dizzy. The events caused hospitalization from an unspecified date in 2021. The patient was not tested for COVID post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-22 | pain in extremity |
About 3 days after the first vaccination I started to notice a slight humming or buzzing in my ears...
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About 3 days after the first vaccination I started to notice a slight humming or buzzing in my ears at night. Mostly noticeable when I go to bed not enough after the first shot to keep me from sleeping so didn't think much of it. After the second shot it is more noticeable even during the day. Not so much to be disabling but I do notice it and I have never had this happen before. I had normal side affects for first and second shots otherwise, sore arm, some fatigue and slight chills more so after the second shot as it these symptoms lingered for almost a week but nothing too severe and those are gone now but the humming/buzzing noise is still there in the background. Is there something I can do to help alleviate this or will it go away on its own?
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| 67 | 2021-03-22 | weakness |
Fever, chills, severe nonstop headache, including my entire face, nausea, complete body ache, fatigu...
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Fever, chills, severe nonstop headache, including my entire face, nausea, complete body ache, fatigue, weakness, sudden sweating and severe nausea, extreme weakness disableing my ability to walk upright to even get to the bathroom. This lasted 3 days 03/16/2021 through 03/18/2021. Sever symptoms decreased to managable levels by 03/19/2021, except for off and on nausea. Fatigue, lack of energy and weakness still remain as of the report 03/23/2021
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| 67 | 2021-03-22 | bell's palsy |
PATIENT STATED WENT TO ED ON 3/4/2021 2 WEEKS AFTER 1ST DOSE OF COVID VACCINE WITH "FLARE UP OF BEL...
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PATIENT STATED WENT TO ED ON 3/4/2021 2 WEEKS AFTER 1ST DOSE OF COVID VACCINE WITH "FLARE UP OF BELL,S PALSY" TO RIGHT SIDE OF HER FACE. FOLLOWED UP WITH PRIMARY CARE PHYSICIAN AND WAS STARTED ON PREDNISONE.
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| 67 | 2021-03-22 | pain in extremity | Ringing in ears and sore arm |
| 67 | 2021-03-23 | weakness |
1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV ...
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1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV sedation, put me on my side. I remember gagging and then i woke up. My chest was burning and they were talking to them, OZ mask because SPO2 had dropped to 48. They needed to monitor me longer, took to recovery, and put on bronchodilator (?) thru the O2 mask. They started and IV antibiotic for 90 minutes. SPO2 went back to 98. I went home, felt weak. The Dr said to take it easy next couple of days. Work stated to only come back when feeling normal. My husband tested for COVID 20th. 1/26 I tested COVID +. I felt like it would be negative due to having both vaccines but it wasn't.
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| 67 | 2021-03-23 | flushing |
Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/...
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Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/87. Symptoms began 30 -40 minutes after vaccines.
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| 67 | 2021-03-23 | tingling, numbness |
Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vacc...
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Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vaccine; Numbness and tingling of both legs and feet which continue since day two of the second Covid 19 vaccine; This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 02Mar2021 12:15 in right arm for COVID-19 immunization. The first dose was on 09Feb2021 12:15 PM in right arm. Medical history was not reported. There was no allergies to medications, food, or other products. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced numbness and tingling of both legs and feet on 04Mar2021 01:00 which continued since day two of the second COVID 19 vaccine. There was no treatment received for the adverse event. The event was considered serious due to disabling/incapacitating. The outcome of event was not resolved. The information on the lot/batch number has been requested.
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| 67 | 2021-03-23 | tingling |
SOB, L arm tingling, lightheaded. Evaluated by EMS-Transported to Emergency room/department or urgen...
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SOB, L arm tingling, lightheaded. Evaluated by EMS-Transported to Emergency room/department or urgent care.
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| 67 | 2021-03-24 | pain in extremity |
1st shot could lift arm all day and very dizzy felt sick for 3 days only, 2nd shot I went home and t...
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1st shot could lift arm all day and very dizzy felt sick for 3 days only, 2nd shot I went home and took a IB 800 like the guy told me because I told him about my reactions with the first one, I had no problems until the 4th or 5th day after the shot now I have continuing Joint aches,. pains in legs wrists. neck. its like my fibromyligia has came back in full force. I feel like crap! Headaches and hurt all over in my joints back just like I used to 20 years ago, I is very crappy!!
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| 67 | 2021-03-24 | pain in extremity |
Approximately 10pm I started getting diarrhea. I had 5 bouts of it during the first night. I took pe...
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Approximately 10pm I started getting diarrhea. I had 5 bouts of it during the first night. I took pepto bismal and it stopped for one day , which was the 21st. On the 22 I woke up with more diarrhea and took Imodium. It stopped the rest of the day until evening when my stomach started to feel like Ibwss going to get nauseated. I took an Imodium. 23 I felt a little nauseous and took pepto bismal. 24 and 25th I feel fine but I still have soft stools and some water excrement. A little ache in left arm for a little bit of time today.)
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| 67 | 2021-03-24 | tremor |
Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but not...
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Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but noticed some lower abdominal discomfort. 4th day had loose stools and noticed some burning when urinating.. Late in the day had a splitting headache, i never get headaches, took Tylenol and felt better. At 2 am that night woke up with teeth chattering and limbs shaking. Urinated and noticed a pink tinge. My husband took me to the ER ( He had had a similar reaction to his first Pfizer shot) Found to have a fever, increased heart rate and a raging bladder infection (significant amount of blood in urine). Treated with Keflex via IV . Went home with a presciption for Keflex They are running a culture. I HAD COVID IN NOVEMBER AS DID MY HUSBAND IT APPEARS THAT MAYBE ONE DOSE WOULD HAVE BEEN SUFFICIENT FOR US. I HOPE THIS WILL BE EVALUATED AND THE PUBLIC INFORMED OF BEST PRACTICE
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| 67 | 2021-03-24 | pain in extremity |
No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrh...
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No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrhea, sore arm 74 hours- diarrhea
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| 67 | 2021-03-24 | migraine |
Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at va...
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Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at vax site and extreme tiredness. Symptom onset was 12 hours after the shot.
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| 67 | 2021-03-25 | discomfort, muscle spasms |
A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The...
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A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The injection site and right arm became extremely heavy and painful. Overnight, I experienced fever, extreme muscle cramping and a burning sensation in all of my joints. Took a Tylenol at midnight which helped. Fever remained at 99.8 which is high for me. This lasted for the next 24 hours. Today, Friday the 26th, I am finally feeling better and fever is gone.
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| 67 | 2021-03-25 | feeling hot, feeling cold, weakness |
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac...
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Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-25 | pain in extremity |
Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am...
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Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am with N&V, chills, fatigue & later in the day diarrhea. Slept off & on throughout the day, drank nothing but Gatorade, Gingerale & water. That night had a temp of 100.8 took Tylenol. Day 4 fever broke able to stomach dry toast & later Chicken Noodle soup but still continued with diarrhea. Day 5 starting to feel a little better, tried to eat normally, but later continued to have diarrhea. From Day 6 to today (Day 12) I still continue to have some nausea & diarrhea & fatigue.
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| 67 | 2021-03-25 | electric shock sensation |
Patient got vaccinated for Pfizer 1st dose. Patient said she was feeling electric shock at the end o...
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Patient got vaccinated for Pfizer 1st dose. Patient said she was feeling electric shock at the end of the 20 minutes wait time. She was breathing normal with no signs and symptoms of severe allergic reaction. I called 911 and watched her until paramedic came and she was transferred to ED. I called her in the evening that day. She said she was feeling better. She said no one examined her in ED and she came back home.
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| 67 | 2021-03-25 | burning sensation |
Urticaria. With pain , burning, itching....cortisone cream, oral steroids, aspercreme With 4% lido...
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Urticaria. With pain , burning, itching....cortisone cream, oral steroids, aspercreme With 4% lidocaine. Benedryl orally and famodine. 2 visits to clinic for this rash which continues to spread
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| 67 | 2021-03-25 | depressed level of consciousness |
Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a lit...
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Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a little achy and a slight headache. During the night, I ached all over, had a terrible headache, the muscles in my neck felt like they were drawing up, I had fever, but didn't get up to check it, my joints and bones ached, I had chills and it was a miserable night. The next morning I got up to make my breakfast and I kept trying to pass out and would have to sit down. I was sweating real bad and finally went to lay down. My husband fixed my lunch and I began to feel like my eyes were getting black, and then I slumped over and he said my head was bobbing on his shoulder. I could hear him saying my name, but I couldn't respond. Right after I cam to, I began to throw up at the table. He called an ambulance and they came and check me out. My blood pressure, blood sugar, EKG, and pulse ox were all normal. I refused going to the hospital, but I didn't know what the hospital could do for me. I called my family physician's office, but never heard back from them. I hear the second shot is worse than the first, so I am not sure if I should take the second shot. Also, strangely enough, my arm wasn't sore. Every time I have the flu shot I feel bad for a couple of days. I also felt bad after my Shringrix shot and pneumonia shots.
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| 67 | 2021-03-25 | burning sensation |
presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following th...
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presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following the onset of the SOA she began to have diaphoresis, lightheadedness, and a burning sensation in her chest that radiates to her back. No nausea or vomiting. She reports checking her heart rate and was tachycardic. She tried to bare down and walk off the tachycardia, with no relief. While she was driving to the ED, her symptoms gradually resolved
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| 67 | 2021-03-26 | pain in extremity, feeling cold |
1st shot: the following morning felt like I had a cold. symptons over by noon 2nd shot: felt good ...
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1st shot: the following morning felt like I had a cold. symptons over by noon 2nd shot: felt good and got sleepy early and am sleepy the next day, sore arm for 24hrs then all good!
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| 67 | 2021-03-26 | nerve pain |
I'm an RN, so I can say this with a basis of medical knowledge. I had my first Covid Pfizer dose on...
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I'm an RN, so I can say this with a basis of medical knowledge. I had my first Covid Pfizer dose on 2-12-2021 and my second dose on 3-5-2021. 1. I began having sharp, stabbing, intermittent pain along several dermatomes approximately two days after the second dose on 3-5-2021. It is now 3-27-2021, and the intermittent pain continues. 2. After the first dose on 2-12-2021, I began to lose more hair than I normally do on a daily basis. Since the second dose of the vaccine, I'm losing handfuls of hair everyday. I'm finding clumps of my hair on the floor and even in my bed. It's most disconcerting. I'm not sure what's causing either one of these symptoms, but I felt I should report it. I have NOT seen or talked to my internist about these symptoms. Being an RN, I'm trying to ride out the symptoms.
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| 67 | 2021-03-26 | pain in extremity | Very sore arm, body aches, lack of appetite, and extreme tiredness |
| 67 | 2021-03-26 | feeling jittery | wakefulness, jitters, achy |
| 67 | 2021-03-27 | weakness | Body aches, chills, extreme fatigue, weak, headache |
| 67 | 2021-03-27 | weakness | I was fine for a few days then got really sick on 5 th day & have felt bad since then. |
| 67 | 2021-03-27 | numbness, pain in extremity, sensory loss |
Pfizer-BioNTech COVID-19 Vaccine I have had numbness and occasional pain in my feet as a result of s...
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Pfizer-BioNTech COVID-19 Vaccine I have had numbness and occasional pain in my feet as a result of scoliosis. After the first shot, I experienced additional numbness in both feet as well as some loss of sensation in my left calf. Additionally, I experienced severe pain in my toes.
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| 67 | 2021-03-27 | migraine |
Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever clim...
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Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever climbed to 103., nauseous and vomiting. Slight headache and diahhrea on 3rd day following vaccine
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| 67 | 2021-03-28 | pain in extremity |
Oddest thing, I know how bizarre this sounds. About 8 hours after my injection, I had moderate pain...
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Oddest thing, I know how bizarre this sounds. About 8 hours after my injection, I had moderate pain in my left (injection) arm. However, I also developed the same or greater level of pain in my right (non-injection) arm. The pain was located in my upper arm, exactly the same area where I experienced pain in my injection arm. The pain lasted about 18 hours, fading away after that. I had the same reaction to the second dose of the vaccine, given three weeks following the first. I had less pain after the second shot, and the "mirror" pain in the other arm was also less. This lasted between 12 and 18 hours, and then the pain in both arms faded away.
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| 67 | 2021-03-29 | involuntary muscle movements, tingling, numbness |
Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on le...
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Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on left side. lasted a brief time--less than 20 minute. Day 5 paresthesia and numbness on waking up on left side, increased in intensity during the day. Difficulty walking and using left side. Muscle control lacking and balance very poor. The intensity of this fluctuates--there are days that improvement seems to be happening and then very bad days. Admitted to the hospital on Wednesday, March 24, 2021, via the ER. MRI, CAT scan, heart monitor, --these did not show evidence of a stroke as suspected at the time. The neurological symptoms persist, at times including numbing on the left side of my face.
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| 67 | 2021-03-30 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient r...
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Sore arm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose 2 via an unspecified route of administration on 04Mar2021, at 13:15 as single dose for covid-19 immunization. Medical history included Crohn's disease from an unknown date. Concomitant medication included adalimumab (HUMIRA AC) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergy and BNT162B2 for covid-19 immunization on 11Feb2021. On 04Mar2021, the patient experienced sore arm approximately six hours after injection. Prior to vaccination, the patient had not been diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The outcome of sore arm was recovered in Mar2021.
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| 67 | 2021-03-30 | discomfort |
Sudden low back pain; stiffness; difficult to get comfortable; very difficult to stand up or move ar...
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Sudden low back pain; stiffness; difficult to get comfortable; very difficult to stand up or move around; very difficult to stand up or move around; bedridden; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiration date: Unknown) on 09Feb2021 at 24:00 via an unspecified route of administration in the right arm at SINGLE DOSE for COVID-19 Immunization in the hospital. The patient's medical condition included Breast cancer from 2020, NDPH (New daily persistent headache) since 1973 and Food intolerances not anaphylactic reactions: Gluten, peppermint from an unknown date and unknown from ongoing. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261, Expiration date: Unknown) on 19Jan2021 at 11:30 via an unspecified route of administration in the right arm at SINGLE DOSE for COVID-19 Immunization. The patient had not used any other vaccine in four weeks and not in two weeks. On 10Feb2021 18:00 the patient had sudden low back pain and stiffness beginning about 36 hours following 2nd vaccination. (The first 36 hours, I felt great-seemed to have extra energy. No injection site pain.) Pain and stiffness made it difficult to get comfortable, and it was very difficult to stand up or move around. I was bedridden for about 24 hours. Today is day 5 after vaccination, and I still have some pain/stiffness albeit much less severe. The patient had not tested for COVID-19 prior to vaccination and post vaccination. The patient did not receive treatment medication. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-31 | feeling hot, pain in extremity |
inflammation; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was r...
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inflammation; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil; skin is dry from being inflamed; skin is dry from being inflamed; skin reaction red rash under both armpits; skin reaction red rash under both armpits; swelling in arm; soreness in arm; This is a spontaneous report received from a contactable nurse (patient). A 67-year-old female nurse reported for herself that she had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9809), via an unspecified route of administration in left arm on 09feb2021 14:00 at single dose for prevent the covid virus. Medical history included female surgery. Concomitant medication included colecalciferol (D3) at 3000 iU, daily, macrogol 3350 (MIRALAX) at alternate day for female surgery. The patient's had a past drug included included Zyrtec for seasonal allergies like dust and stated that she took no Zyrtec at all for either shots. The patient stated that she takes macrogol regularly every other day for the last 5 years for a female surgery and her female surgeon says she needs it to stay out, but the ingredient is also in macrogol. The patient reported that she had both vaccinations and had the rosy arm pits red rash and sometimes she get a reaction in my ears if it flares up and gets hot. For 5 weeks she was taking children's Benadryl. The patient had a quicker reaction with the second dose and still had some lingering effects from the first dose when I got the second. On 09Feb2021 she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient reported she still feels it though and it has been five weeks and she tries to turn arm and can still feel it but it is not bad. The patient stated a day later she had her first skin reaction which was a red rash under both armpits. The patient stated she waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. It was reported that she had been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The patient stated she called primary care doctor and talked to nurse to see if she should try some other medication before second shot and the nurse recommended, she should not get second shot that she should see an allergist. The patient stated she asked the nurse about the quality of first and second shot working together if she had waited and not got second shot and the nurse told her she would have to come back at least four days after the second shot was due or it would not work together. The patient stated she went ahead and got the vaccine and it has not been life threatening as of now. The patient stated she saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient then stated she would take Benadryl. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The patient reported her Allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. It was reported that the Allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient then stated but it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. The patient stated it is not a flare up like when someone cannot eat seafood and stuff like that. The patient stated she wanted to wait for second dose before contacting Pfizer to see what would happen. The patient stated she is really blossoming under the armpits and they are rosy, red but no blisters and her skin is dry from being inflamed all this time. The patient squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. It was reported that with the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose. It was reported that she hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. It was reported that she was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The patient did not experience any swelling or soreness with second shot. The patient stated she experienced ears would get warm feeling very hot only six times and it was usually at night or in the morning from the second shot. The patient stated every once in a it while flare up from the first. The patient stated the hurt was always in the center of armpit not in the armpit. Caller stated thank goodness she can still shave. The patient stated past couple of days her skin has been dry. The patient stated she has used hand cream but is afraid to put anything else on it because of reaction. and she will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient stated she has been putting water on at night which could have dried it out. The patient stated soreness in arm happened right after first shot. The patient stated she did not want to double up on Allegra as she was not sure what the reaction would be. The patient stated the medical ingredient was Fexofenadine HCL 180 mg antihistamine and stated she only took one pill as it did not work. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient stated she had the Pneumonia shot and never had swelling. The patient was not recovered from soreness in arm, skin reaction red rash under both armpits, skin is dry from being inflamed and recovering from inflammation, outcome was unknown for sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil and swelling in arm. The reporter assessed events are related to drug. The outcome of the event inflammation was recovering, ear discomfort, Feeling hot, swelling in arm was unknown and rest of the events was not recovered.
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| 67 | 2021-04-01 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old fema...
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Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included hypertension, type 2 diabetes mellitus, kidney disease, and known allergies to Penicillin and Sulfa drugs. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE) and dulaglutide (TRULICITY); both taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 (13:00 Friday), the patient experience left side of face became numb and droopy with droopy eye lid and numb lips. The patient sought medical care; stroke was ruled out. The diagnosis was Bell's Palsy. Valacyclovir hcl 1-gram tab was prescribed. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. The event was considered serious (seriousness criteria: important medical event). Information about lot and batch number was requested.
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| 67 | 2021-04-01 | bell's palsy |
Bell's palsy; got second dose early on 11Mar2021, it was originally scheduled for 14Mar2021; got sec...
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Bell's palsy; got second dose early on 11Mar2021, it was originally scheduled for 14Mar2021; got second dose early on 11Mar2021, it was originally scheduled for 14Mar2021; This is a spontaneous report from a contactable consumer (patient's daughter). A 67-year-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the left arm on 11Mar2021 at 19:20 (batch/lot number: EN6207) as a single dose for COVID-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medications included ongoing high cholesterol meds (unspecified). The patient had no vaccinations within four weeks prior to the first administration date of the suspect vaccine. The consumer was calling on behalf of her mother who doesn't speak English who got the Pfizer COVID-19 vaccine second dose on the 11Mar2021 then was admitted to the hospital on 17Mar2021 with a diagnosis of Bell's palsy. She said that her mother's vaccine card was handwritten and does not provide NDC/EXP. She said that the LOT for her mother's first dose was EN6203, which she got on 21Feb2021 at 02:30PM. She said that the second dose for her mother was injected at 07:20PM 11Mar2021. She said that her mother was admitted to the hospital at 03:00PM 17Mar2021 after she took her to the emergency room. She said her mother was prescribed steroids and antivirals. She said for diagnosis at first they did CAT scan, X-ray, MRI, and an echo to verify not a stroke, which those were negative for stroke. She said that her mother was discharged from the hospital yesterday on the 18th at about 03:15PM. She said her mother was currently feeling about the same right now, she has no issues with motor skills, it was primarily facial droopage. She clarified that the steroids her mother was prescribed for treatment was Prednisone 20 mg, that came in a pharmacy bottle that does not provide NDC/LOT/EXP on the label. She said the label says discard by 18Mar2022. She said her mother was prescribed to take Prednisone 20 mg tabs, 3 tabs by mouth in the morning for 6 days. She says for the antivirals for treatment, her mother was prescribed Valacyclovir HCl 1 gm tab twice a day morning and night for 7 days. She said this was also dispensed in a pharmacy bottle without NDC/LOT/EXP provided on pharmacy label. She said her mother has not had any other recent vaccinations or started any new medications. She asked if the purpose of calling was just to give information about what had happened, since the hospital said to report it to Pfizer, and she was not sure exactly why. She said her mother was on insurance plan and she doesn't know if there was any assistance with that for hospital bills, but they didn't say if there was anything towards that. She said she wonders if there was information with medical bill assistance for this being kind of diagnosed or someone to notify. She said she would also like to know if this could be because her mother's second dose was early, it was originally scheduled for 14Mar2021, but due to the weather there, the blizzard, they had her mother come in early to get shot. The seriousness criteria of the event Bell's palsy was hospitalization, duration of stay was overnight: 17Mar2021 to 18Mar2021. The outcome of the event Bell's palsy was not recovered.
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| 67 | 2021-04-01 | pain in extremity |
microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her...
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microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her finger pads; erythema and tenderness progressively over weeks of all her finger pads; crop is elevated; This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 25Feb2021 12:00 (Lot number was not reported) as single dose for covid-19 immunization at age 67 years old. The vaccine was given in a Pharmacy or Drug Store. Medical history included APLA, hypothyroid, obesity, and allergies. The patient was not pregnant. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included warfarin sodium (COUMADIN); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); all taken for unspecified indications, start and stop date were not reported. No other vaccines administered in four weeks. The patient previously took erythromycin and PCP and experienced allergies to both. The patient previously received the first dose of bnt162b2 intramuscular in left arm on 04Feb2021 12:00 PM (at age 67 years old) for covid-19 immunisation. The patient with APLA on coumadin 1-2 days after receiving the vaccine developed erythema and tenderness progressively over weeks of all her finger pads, crop is elevated (as reported) and some splinter hemorrhages suspect microemboli. Just to left hand, systemically well. The adverse evemts occurred on 26Feb2021 12:00 PM. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given to patient for the events. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-03 | feeling hot |
Skin reaction red rash under both armpits: Caller stated the event started the first day after the f...
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Skin reaction red rash under both armpits: Caller stated the event started the first day after the first shot then still having reaction from the second shot; Skin reaction red rash under both armpits; Ears would get warm feeling very hot; after the second shot the flare up was quicker; skin is dry from being inflamed; skin is dry from being inflamed; blossoming under the armpits and they are rosy red but no blisters; hurt was always in the center of armpit not in the armpit; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization. Medical history included surgery from an unknown date and unknown if ongoing. Concomitant medication included vitamin D3 taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Miralax. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization and Pneumonia shot and never had swelling. The patient had rosy arm pits red rash and sometimes get a reaction in ears, if it flares up and gets hot. The patient stated, "For 5 weeks I've been taking children's Benadryl. I had a quicker reaction with the second dose than I did the first one but I still had some lingering effects from the first dose when I got the second. How long do these side effects usually last?" The patient had second COVID 19 vaccine and also had first one. The first dose was on 09Feb21 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient still feels it though and it has been five weeks. The patient tries to turn arm and can still feel it but it was not bad. A day later she had her first skin reaction which was a red rash under both armpits. The patient waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. The patient has been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The primary care doctor and talked to the patient to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. The patient got second shot and talked to nurse there. The nurse told the patient she would have to come back at least four days after the second shot was due or it would not work together. The patient went ahead and got the vaccine and it has not been life threatening as of now. The patient saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient would take Benadryl. The physician told the patient to try to take Allegra 24 hours but the patient stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient stated, it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. It was not a flare up like when someone can not eat seafood and stuff like that. The patient still has a rosy armpit. The patient has not seen her doctor since last year when she had a physical. The patient would inform her doctor about these events. The patient stated she is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. The patient stated, "the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose." The patient hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. The patient was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. Caller stated the nurse the first time gave the shot like when you see people getting shots on tv they put it really high up in muscle. The patient considered the event as medically significant and that it is ongoing and has worsened. The hurt was always in the center of armpit not in the armpit. The past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. Just annoying. The patient will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient has been putting water on at night which could have dried it out. Some days is worse than others more red. This is persisting. Soreness in arm happened right after first shot. The shot was given in the proper way but seemed like more of a reaction. The second shot is much better and that she does not feel it at all. The patient can still feel where the vaccine went in left arm. It was annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The patient was not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard. Before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. The patient was hoping it will fade out eventually. The patient did not want to double up on Allegra as she is not sure what the reaction would be. The medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient only took one pill as it did not work. 24 hour Allegra, 180mg antihistamine 15 tablets per box. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient usually takes Zyrtec for seasonal allergies like dust. She took no Zyrtec at all for either shots. She felt the Benadryl worked better and quicker. The patient was at the Allergist she asked what is in this vaccine like what chemical. She looked up the ingredients but did not understand. Her friend told her Polyethylene glycol was in both the Pfizer and Moderna vaccine. The patient had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient stated she took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The patient stated the medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient stated she only took one pill as it did not work. Sample of the product was available to be returned. The packaging was sealed and intact. The outcome of the event "Ears would get warm feeling very hot" and "after the second shot the flare up was quicker" was unknown. The outcome of the rest of the events was not recovered.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of events rash and erythematous rash (allergy context) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-06 | numbness, facial pain |
Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her...
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Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her ear; Shingles; Pain; Ramsay-Hunt syndrome; Loss of hearing; Itchy on the left side of the face; Blisters on face, temple, ear; Left side of her face is scorched bright red and painful; Left side of her face is scorched bright red and painful; Numbness; no feeling in her mouth on the left, cheek, temple; Numbness; no feeling in her mouth on the left, cheek, temple; Blisters in her mouth; Pain, teeth started hurting went to her temple; Pain, teeth started hurting went to her temple; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 20Feb2021 (09:30) as a single dose, with route of administration unspecified, for COVID -19 immunization at the pharmacy/drug store (not a military facility). Medical history included shoulder surgery in Aug2020; ongoing abnormal blood pressure; ongoing heart disorder; and was in a pacemaker and defibrillator. Concomitant medications included carvedilol for abnormal blood pressure from 2012 and ongoing; losartan for heart disorder from 2012 and ongoing; and furosemide from 2017 and ongoing. On 05Mar2021, the patient had Ramsay-Hunt syndrome and loss of hearing. On 21Feb2021, the patient had pain/teeth started hurting and went to her temple. On 22Feb2021, the patient had blisters in the mouth; left side of the face was scorched bright red and painful; and numbness/no feeling in the mouth on the left, cheek and temple. On 23Feb2021, the patient had blisters on face, temple and ear. On 25Feb2021, the patient was itchy on the left side of the face. On an unspecified date, the patient had rash in her mouth/broke out on her lips and ear; shingles; and pain. The events, 'pain/teeth started hurting and went to her temple', 'blisters in the mouth', 'blisters on face, temple and ear' and 'pain', had resulted into physician's office visit. The patient's ENT had the patient put on treatment with valaciclovir (VALTREX) and prednisolone for the 'blisters in the mouth', 'blisters on face, temple and ear'; treatment for 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'itchy on the left side of the face', 'rash in her mouth/broke out on her lips and ear', 'shingles' and 'pain'; and unspecified ear drops for 'loss of hearing'. The outcome of the events was not recovered for 'Ramsay-Hunt syndrome', 'loss of hearing', 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'numbness/no feeling in the mouth on the left, cheek and temple' and 'itchy on the left side of the face'; was recovered on 04Mar2021 for 'blisters in the mouth' and 'blisters on face, temple and ear'; and was unknown for 'rash in her mouth/broke out on her lips and ear' and 'pain'. The patient had received the second dose of vaccination on 20Mar2021. Information about batch/lot number has been requested.
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| 67 | 2021-04-12 | numbness and pain in extremities |
Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her...
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Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her neuropathy, since the vaccine, has acted up.; her neuropathy, since the vaccine, has acted up.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (did not want to get Covid). Medical history included hypertension (she has been on medications for it, and she doesn't know how long), Cancer (Cancer Survivor. for probably 8 years), ongoing Neuropathy (since she had chemotherapy 7.5 years ago), chemotherapy. Concomitant medication included telmisartan tablet at 80 mg once a day taken for hypertension (stated she has been taking it for a couple of years). The patient experienced her neuropathy, since the vaccine, has acted up on an unspecified date in 2021, glands in her throat swelled up on 20Mar2021, her throat was inflamed on an unspecified date 2021, painful to swallow on an unspecified date in 2021, throat pain, sore on an unspecified date in 2021. Caller stated she was the recipient of the Pfizer vaccine. Caller stated her first shot was 15Mar2021, and in 5 days, all of a sudden her glands in her throat swelled up, and asks, is that normal, Reclarified, caller stated the Pfizer vaccine, she was not sure but as she gets older, she shrinks. Caller stated that she was due to get her second shot next week and was a little leery. Glands in throat swelled up: Start: caller stated she did not know than stated 20Mar2021, she thought. Stated it was resolved, she did not feel it, it resolved 2-3 days later, maybe on the 23Mar2021. Caller stated it was weird, her throat was inflamed and it was painful to swallow. She did not know, it was hard to tell, it feels a little sore. Caller stated she did not know she has no idea. Throat inflamed caller did not the same day, maybe that Saturday, or the night before, she did not remember. She reports she did a lot of gargling with salt water and her throat was sore, what the heck. She stated she feels much better. Recovered. Caller stated she did not remember. In 2021, painful to swallow caller Stated probably the same day as the glands or the night before. She Stated no, it was not difficult to swallow anymore. She did not know the end date, it was better 3 days later. Throat pain and sore in 2021, caller stated no, it was all together around the same time. Caller stated she woke up with it. Caller stated the pain has gone, and she did not know the date, once it went away, she didn't think about it. She was not sure, if it was recovered, or recovered completely. Caller stated she has neuropathy because of chemotherapy, but reports that her neuropathy, since the vaccine, has acted up. Stated the vaccine must have been given between 1 and 1:30, she had the appointment at 12:45, but didn't get in after 1:00. Caller stated all she saw was N534, she thinks, it was an E or Z the way that they wrote it. Caller gave ZPN534, reclarifies, she stated she thinks they wrote it so sloppily.. She did not know if that was an E or ZPN534. I was having hard time reading it. It could be a E or it could be a Z, P, I think it was N 534. For events, her neuropathy, since the vaccine, outcome was not recovered, glands in her throat swelled up, outcome was recovered on an unspecified date in 2021, her throat was inflamed outcome was recovered on an unspecified date in 2021, painful to swallow, outcome was recovered with sequelae, throat pain, sore outcome was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 67 | 2021-04-12 | one side paralysis |
problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's ...
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problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; dragging her feet; trouble standing up; feels like a stroke in her leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), intramuscular, administered in the left arm on 24Mar2021 at 12:30 as a single dose for COVID-19 immunization. Medical history included stroke on Dec2015 and Feb2016 and ongoing left side, having weakness since she had a stroke. The patient's mother had a really bad stroke on an unspecified date in her 80's. The patient's concomitant medications were not reported. The patient previously received the first dose of BNt162B2 (lot number: EN6208) on 03Mar2021 for COVID-19 immunization and had a sore right arm. It was reported that on 26Mar2021, the patient was dragging her feet and having trouble standing up. This occurred after her second shot. She has had a problem with her left side, having weakness since she had a stroke at the age 62 years. She worked through it and it was fine. But when she took the 2nd shot, it's been bothering her through the weekend. Her left side weakness worsened. She described the feeling like the stroke. Her doctor said when she gets sick, it could mimic her stroke symptoms. She added it is worse in the morning when she tries to get up. The patient added that her leg is affected, and feels like a stroke in her leg on Mar2021. She had no treatment for her experience and doesn't know if there is a treatment for what she is experiencing. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-04-16 | one side paralysis, unresponsive to stimuli |
entered room drooling . right sided neglect BP elevated . not following command send to ER A...
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entered room drooling . right sided neglect BP elevated . not following command send to ER Admited to hospital with CVA PCP Note upon return - Patient is a 67-year-old female with past medical history of hypertension, MS, dementia, CHF, chronic kidney disease and hyperlipidemia who was sent from the facility to the emergency room for altered mental status and possible CVA. In the emergency room, blood pressure was elevated at 170/100 and she was noted with more pronounced weakness in left upper extremity and lower extremity and left gaze. Neurosurgery was consulted and deemed patient a poor candidate for TPA due to recent GI bleed. Stroke workup was negative for acute findings and a brain MRI ×2 was negative. EEG was ordered to rule out seizure and it was normal and neurologist recommended to start patient on Keppra. Patient was initially started on aspirin which was stopped due to drop in H&H. Patient was also noted with low-grade fever and infectious workup including blood cultures, UA and extensive imaging did not have evidence of infection and COVID-19 was negative. Social services spoke to patient's sister who is the POA regarding advanced directives and she requested to change advanced directives to DNR/DNI/no PEG and orders noted in chart. Patient's symptoms progressively improved and discharged back to the facility and resting in bed comfortably in no acute distress
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| 67 | 2021-04-17 | weakness |
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell...
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Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | pain in extremity |
Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration...
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Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration inside of the left ankle and bottom of heel; she is not experiencing any arm pain. It is in her ankle and feet; Hallucinations; ankle swollen; This is a spontaneous report received from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Mar2021 10:00 (Batch/Lot Number: EN6208; Expiration Date: Jun2021) as a single dose for COVID-19 immunization. Patient received the first dose on 04Mar2021 10:00 in the left arm (Batch/lot number: EN6200, Expiration Date: Jun2021) and she had headaches, arm ache, and hallucinations which would go and come. When she would try to sleep, the hallucinations would go and come but then the hallucinations stopped prior to getting the second dose. Headaches started a couple of days after the first dose probably started the next day and started coming and going. This stopped prior to the second dose probably a week or week in a half maybe two weeks before getting second dose. The headache only lasted about half a day, it wasn't that bad. She recovered completely. Arm sore, red only happened with the first dose as her arm did not hurt at all after the second. This started the next day or even the same day but she kept it comfortable and probably stopped within the first week and it did not come back either. She has recovered completely. Sharp pain through arm go and come. This started after the first dose so in that week or week in a half area and it stopped about at least a week before the second dose somewhere in that period of time. She has recovered completely. Hallucination: she was laying down at night and something would come across her head that she was not thinking. It started right after the first dose probably first, second, or third night but it stopped like all the rest of it in same period of time. She had recovered completely prior to getting the second dose. Medical history included arthritis and diabetic. The patient's concomitant medications were not reported. Patient had the flu vaccination for the first time in Oct2020 or Nov2020 and did have a headache and she has never taken the flu vaccine before. The patient had side effects from the vaccine she received on 25Mar2021. Her ankle was swollen on 28Mar2021 but that went down on 30Mar2021. This has left discoloration inside of her left ankle and bottom of her heel and it was sore from 30Mar2021 and ongoing. It was not red, tender, or bruised. The bottom of her heel hurt when she put pressure on it and walked on 31Mar2021. It was ongoing but was off and on and it has worsened. She had her feet up on the bed. As treatment, patient used heat, ice, and has been elevating her feet. She called her doctor and doctor told her to keep doing it since she has been doing it since Monday. With the second shot, she is not experiencing any arm pain. It is in her ankle and feet and then the hallucinations still go and come and she sees images that come still but do not stay they just go and come. After the second dose, she had this last night and the night before last, she would not be thinking it but it would appear in her mind and she was wondering why it was doing that but she thought maybe a week or two it will stop and come down. This started on 28Mar2021, Sunday after the second dose and is still going on. Outcome of the event ankle swollen was recovered on 30Mar2021, of the event arthralgia was unknown, and of the other events was not recovered.
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| 67 | 2021-04-17 | pain in extremity |
Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous rep...
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Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose). Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | bell's palsy |
On Saturday, 27Mar, it was Bell's Palsy paralysis of the right side of my face.; By Tuesday, 23Mar, ...
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On Saturday, 27Mar, it was Bell's Palsy paralysis of the right side of my face.; By Tuesday, 23Mar, I had an earache and sore throat.; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 67-year-old female patient (who was not pregnant at the time of vaccination), received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6204 and expiry date was not provided), via an intramuscular route of administration, in left arm on 20Mar2021, at 14:30 as single dose for COVID-19 immunisation. Patient's medical history included breast cancer in 2009, gall bladder disorder in 2020, tonsillectomy in 1965, hysterectomy in 1986 and patient had known allergies to Latex, nail polish remover and sensitivity to fragrances. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EN6198, and expiry date was not provided), via an intramuscular route of administration in left arm on 27Feb2021, at 12:30 PM as single dose for COVID-19 immunisation. No other vaccination received in past four weeks and no other medications in past two weeks of vaccination. Patient stated that by Tuesday, 23Mar2021 at 05:00, she had an earache and sore throat. On Saturday, 27Mar2021, it was Bell's Palsy paralysis of the right side of her face. As a result, the patient had to visit Emergency room/department or urgent care and physician office visit. The patient has been tested for COVID, post vaccination, on 27March 2021, which resulted as negative. The patient was treated for the adverse events with Prednisone and antiviral medicine. Outcome of the events was not recovered.
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| 67 | 2021-04-18 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to dialysis session two days after vaccinatio...
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Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to dialysis session two days after vaccination reporting right lower extremity pain and redness for one week. Admitted for management of cellulitis, received antimicrobials, and discharged to home improved and medically stable.
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| 67 | 2021-04-22 | pain in extremity |
Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the le...
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Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the left side of my neck. At about that same time, I developed pain in my left wrist and in the pinky and ring fingers of my left hand. Pain has continued for more than two months now despite regular stretching of the affected areas, use of a wrist brace, and applications of Icy Hot patches to my arm and upper back.
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| 67 | 2021-04-24 | weakness, paralysis |
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject...
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Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
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| 67 | 2021-04-24 | pain in extremity |
blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report fro...
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blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534),dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included ongoing Beta thalassemias. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated she has never had a problem with vaccinations, and she gets the flu vaccine every year. The patient reported that after the first injection coincidentally she did develop a blood clot in her lower leg. She thinks that it was due to a plane ride, but she has never had a blood clot before the injection. She added that she had the first dose on 16Mar2021 and developed a clot in a week. She further clarified that she got her first injection on 16Mar2021 and realized when she went on a flight, which is not that far she developed that clot and was having problems shortly after flight home on 24Mar2021 where her leg swelled up and she is on blood thinners since she went to the emergency room. She added that she developed the clot sometime between that flight and 02Apr2021. She had a doppler study on an unspecified date and it showed a blood clot. She stated that the outcome was she does not have the blood clot (as reported) but she will be on blood thinners and she needs to follow up on her scan to see if the clot issue is resolved but she will not have a doppler scan for another month or two and the blood thinner she is taking is Xarelto. She also stated that her right leg swelled up and it felt like a log. She reported it felt achy and swollen quite a bit from knee down and her leg was achy. It started between 24Mar2021 and by time she went to the emergency room she was not getting better. She had her symptoms for a week and toward the end of the week she thought she had a blood clot since it was not getting better it just got worse. She added that right now it is not swollen but she has been supine, and she does believe that it is better. The outcome of events was recovering. (As reported "outcome is unknown but pretty sure it has improved because of the blood thinners"./She stated she does not think it has resolved because it takes time for clots to resolve./She added that right now it is not swollen but she has been supine, and she does believe that it is better.) The reporter stated for the seriousness criteria for event blood clot: she believes as a nurse that any blood clot is extremely dangerous, and she was not hospitalized but obviously a blood clot is serious, and she could have ended up with pulmonary embolism. The seriousness for events right leg swelled and achy was reported as medically disabling. Causality assessment: Patient stated for the blood clot she has doubts if it was related to the vaccine but is it something that should be known about; for the leg swelling and achy she has doubts but it could have been the plane ride.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The plane ride may provide an explanation for the events. The case will be reassessed if additional information becomes available.
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| 67 | 2021-04-24 | muscle spasms, feeling cold |
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe...
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cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | numbness |
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu...
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face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | weakness |
sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot,...
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sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation. The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot. Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s. The patient's concomitant medications were not reported. The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6. Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site. Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for fever and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-04-26 | feeling of body temperature change, weakness, cold sweat |
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr...
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hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-27 | feeling hot |
Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr p...
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Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr pain to shot; administered in right leg; This is a spontaneous report received from a contactable hcp (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right leg on 15Mar2021 09:30 (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. Medical history included known allergy, asthma, atrial fibrillation, urticaria. Concomitant medications included cetirizine hydrochloride (ZYRTEC) as pre treated; diphenhydramine hydrochloride (BENADRYL) as pre treated. The patient previously received the first dose of BNT162B2 (Batch/Lot number: EN6200) on 20Feb2021 13:00 in left leg by injection for COVID-19 immunization. The patient experienced nausea, dizzy, face hot, trouble breathing/chest tightness, pain to shot, all on 15Mar2021. Clinical course: Pre treated u/ 50mg Benadryl and 1 Zyrtec. 1hr pain to shot. u/in 15 minutes of shot: Nausea, dizzy, face hot, trouble breathing/chest tightness, given oxygen +2 more Benadryl laid down u/ feet up, discharged 1200HR Sx resolved by next day (24hours). The outcome of the events was recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events nausea and vaccination site pain were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "face hot, trouble breathing/chest tightness" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-28 | pain in extremity |
This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
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| 67 | 2021-04-30 | feeling hot, pain in extremity |
bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc...
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bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-04 | feeling hot, pain in extremity |
I felt hives on my forehead; With the 2nd shot my arm was definitely sore; I felt like I had a fever...
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I felt hives on my forehead; With the 2nd shot my arm was definitely sore; I felt like I had a fever but it did not show on the thermometer; This is a spontaneous report from a contactable consumer(patient). A 67-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in Arm Right on 05Feb2021 at 08:00 as SINGLE DOSE for covid-19 immunization. Medical history included breast cancer survivor from an unknown date and unknown if ongoing, food allergy valium, strawberries, bananas, lobster, mahi, whiting fish from an unknown date and unknown if ongoing. The patient received other vaccines within 4 weeks prior to the COVID vaccine via right arm on 14Jan2021. There was no COVID prior vaccination. The patient was not tested post COVID-19 vaccination. Concomitant medications included turmeric [curcuma longa rhizome]; ergocalciferol (VIT D), vitamin c [ascorbic acid], collagen (collagen), olive oil (olive oil). The patient previously took bnt162b2, valium and experienced drug hypersensitivity. On 05Feb2021 at 15:00, The patient stated that, I got hives near my left eye with the first Pfizer shot but I wasn't sure if that was the cause as I do have food allergies. My arm was a little stiff but not significantly and I did not have any other side effects. On 5Feb21, With my second shot, I felt hives on my forehead which confirmed I did have a hive reaction from the first vaccine on 14Jan2021 shot, with the 2nd shot my arm was definitely sore, I wanted to just lay down and I felt like I had a fever but it did not show on the thermometer. However, it is a lot better 24 hours later. My hives have gone down and I feel fine. The patient underwent lab tests and procedures which included body temperature: fever but it did not show on the thermometer. Therapeutic measures were taken as a result of the 2nd shot my arm was definitely sore with Aleve to reduce the pain of the vaccine area on right arm. The events were considered as non-serious. The outcome of the events were reported as recovered. Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122958 same patient, same product( different dose), similar events
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| 67 | 2021-05-04 | pain in extremity, feeling hot |
skin reaction; skin reaction red rash under both armpits; soreness in arm; ears would get warm feeli...
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skin reaction; skin reaction red rash under both armpits; soreness in arm; ears would get warm feeling very hot; swelling in arm; ears would get warm feeling very hot; skin is dry from being inflamed; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203, expiration date not reported), on towards side of muscle in right arm via intramuscular on 02Mar2021 14:00 as single dose for COVID-19 immunisation. Medical history included female surgery (caller stated she takes Miralax regularly every other day for the last 5 years for a female surgery and her female surgeon says she needs it to stay out but the ingredient is also in Miralax. Caller then stated she knew it was not that ingredient causing the reaction), pneumonia (Caller stated she had the Pneumonia shot). Concomitant medications included colecalciferol (D3) at units everyday from an unspecified date and macrogol 3350 (MIRALAX) taken for female surgery. The patient previously took zyrtec [cetirizine hydrochloride] for seasonal allergies like dust (Caller stated she usually takes Zyrtec for seasonal allergies like dust. Caller stated she took no Zyrtec at all for either shots) and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), at the age of 67-years on bicep left arm upper muscle on 09Feb2021 14:00 for Covid-19 immunisation. On an unknown date the patient experienced skin reaction red rash under both armpits, soreness in arm, ears would get warm feeling very hot, swelling in arm, skin is dry from being inflamed. The report received as, Caller received the COVID vaccine and stated she had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. She had second COVID 19 vaccine and also had first one. The first dose was on 09Feb2021 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. Caller then states she still feels it though and it has been five weeks. Caller states she tries to turn arm and can still feel it but it is not bad. Caller states a day later she had her first skin reaction which was a red rash under both armpits. She called primary care doctor and talked to nurse to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. She got to building for second shot and talked to nurse there. She asked the nurse about the quality of first and second shot working together if she had waited and not got second shot. the nurse told her she would have to come back at least four days after the second shot was due or it would not work together. She went ahead and got the vaccine and it has not been life threatening as of now. She saw an allergist three days after second shot. She had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. She would take Benadryl and her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. She took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help and her Allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The Allergist saw her armpits agreed the children Benadryl was working and that she should stick with that, but it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits, after the second shot the flare up was quicker because first shot was already in system still, it is not a flare up like when someone can not eat seafood and stuff like that. She still has a rosy armpit and probably will not see her HCP unless she gets bad but she will go to Allergist. She wanted to wait for second dose before contacting Pfizer to see what would happen. She is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. She is only taking 20 mL of Benadryl in the morning and then evening before bed. The first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose. She hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. Since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. Caller states her sister asked what did she did and she said nothing. Swelling in arm was from the first shot it was really hot like a boil but it was not red it just felt hot, she used a cold compress during the night like a washrag and by the next day it was fine. She got the shot on the left arm on purpose because she was left handed and could move it more but noticed the swelling stayed a while. When she got the second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. She can still feel exactly where she got the first shot. Swelling in arm was not terrible. her allergist felt she made the right decision since it is not life threating like respiratory related or closing of throat like food allergies just uncomfortable and annoying. Skin reaction red rash under both armpits was the event started the first day after the first shot then still having reaction from the second shot. She had the reaction a couple hours later and did wait half hour before leaving after getting the shot with the second shot she did not experience any swelling or soreness. The reason she went ahead and got the second shot at the medical building was she asked the nurse how many people had skin reaction before second shot. Ears would get warm feeling very hot, she only experienced it six times and it was usually at night or in the morning from the second shot. Every once in a it while flare up from the first. The hurt was always in the center of armpit not in the armpit. Skin was dry from being inflamed from past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. The serious criteria is just annoying. She will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. she has been putting water on at night which could have dried it out. Some days is worse than others more red and this was persisting. The second shot is much better and that she does not feel it at all. She can still feel where the vaccine went in left arm. It is annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The soreness had not gone away before she got the second shot so double whammy. She guesses right now it is uncomfortable and that she has had better days. She is not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard, before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. She is hoping it will fade out eventually. Caller stated that the seriousness criteria is medically significant. She is taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. She took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The medical ingredient was Fexofenadine HCL 180mg antihistamine. She only took one pill as it did not work. she had not had an an anaphylactic reaction yet. She is taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. Outcome of the events skin reaction red rash under both armpits, soreness in arm and skin is dry from being inflamed were not recovered and remaining events were unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events skin reaction, rash erythematosus and pain in extremity and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021307484 Same reporter/drug/AE, different patient;US-PFIZER INC-2021307485 Same reporter/drug/AE, different patient;US-PFIZER INC-2021307486 Same reporter/drug/AE, different patient;US-PFIZER INC-2021307487 Same reporter/drug/AE, different patient
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| 67 | 2021-05-06 | weakness, feeling jittery, tremor, seizure |
seizure; Feel woozy; felt even weaker; jittery feeling; shaky; doesn't feel well; It has left her wi...
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seizure; Feel woozy; felt even weaker; jittery feeling; shaky; doesn't feel well; It has left her with a stutter; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration on 02Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first shot on 02Mar2021 and the second shot 25Mar2021. She took the first shot and she wanted to say a day or so after that she got up and did some things around the house and she went to the cloth store. She clarified that she went to the fabric store and came out she had a jittery feeling. Then she began to feel woozy and stated she may need to eat. She drove up to by (withheld) and there was a cookout restaurant in the same vicinity as (withheld). When she went to turn into the lot, she was "shaky" and pulled into the parking space. She added that the best thing is for her to go home. She didn't want to take the interstate and went to the back way just in case something happened. She went home and it was approximately 10 miles away. When she got home, she felt even weaker. Her husband was outside because he fishes and was working on his boat. She told him that she doesn't feel well and was shaky. He told her to go in the house and he would come in. She went in through the basement and when she got to the step her foot wouldn't come up, so she crawled up the steps. When her husband came in, she went into a seizure and had no control. She could hear her husband speaking but couldn't speak so he called. They told him to give her four 81 mg of aspirin. So, he gave her some aspirin. She could hear them when they came in to get her, but she couldn't respond. They took her to the hospital. At the hospital they did two CAT scans and another unspecified test. The patient added that she was concerned because she is a very active person, and this is not her normal talk. Before the shot she did a lot of sewing and that's her business. But a few days after the shot she began to have a lot of seizures and went to the hospital. And when she came home it continued. Before she left the hospital, she had not spoken to anyone. When her husband came in, she couldn't get her words out. It has left her with a stutter, and she decided to go to speech therapy. She went in and a few days it seemed like it had helped. The patient further stated that she is not getting back to normal and needs a walker or cane and she's 68 and healthy. The outcome of events was unknown. Information on lot/batch number was available. Additional information has been requested.
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| 67 | 2021-05-07 | hot flush |
Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches...
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Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches over whole body/ localized around rib cage; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9810) via an unspecified route of administration at left arm on 03Feb2021 17:45 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure, COPD, and allergies to Penicillin, various blood pressure meds. Concomitant medications included ongoing atenolol (TENORMIN) for high blood pressure, ongoing ergocalciferol (VIT D), ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing Multi Vitamin (unspecified). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231, the second letter need to read) via an unspecified route of administration at right arm on 13Jan2021 17:50 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was not prior vaccination. On 04Feb2021 02:00, the patient experienced hot flash (Seriousness criteria: Not Serious). She had headache on 04Feb2021 in middle of night and severe body aches (Seriousness criteria: Not Serious) on 04Feb2021. Next day severe body aches over whole body then by end of day pain was localized around rib cage. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test COVID-19 post vaccination. No therapeutic measures were taken as a result of the events. The outcome of the event hot flash was recovered on 04Feb2021; headache and "severe body aches over whole body/ localized around rib cage" were recovered on 05Feb2021. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-05-10 | pain in extremity |
Patient and I spoke on May 7th, 2021. Her contact information was referred to me by one of the Call...
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Patient and I spoke on May 7th, 2021. Her contact information was referred to me by one of the Call Center staff members. Patient reported that she received her first COVID-19 vaccine (Pfizer) on 2/17/2021 at Health Department. She reports that she is typically "fine with shots, no problem", but when she received her first dose of the Pfizer vaccine "it immediately started hurting". She reported taking round the clock Advil/Motrin and "could feel a knot and radiating into crease of arm". She reported difficulty raising arm to put bra on and awaiting in the middle of the night due to pain. She stated she presented 21 days later for her 2nd dose (3/10/21- right arm) and still had persistent pain in left arm. She stated she has seen a surgeon due to the pain and that they x-ray was negative. She states the surgeon told her that a nerve was affected and gave her a shot of steroids. She reports this has not resolved the pain and that she is taking diclofenac 75 mg BID with pain unresolved. States she has a f/u appt with provider 5/27/21 and will keep appointment.
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| 67 | 2021-05-13 | pain in extremity, cold extremities |
left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swol...
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left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke. Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2020-12-31 | pain in extremity |
on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amoun...
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on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers
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| 68 | 2021-01-02 | hot flush | After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes. |
| 68 | 2021-01-04 | pain in extremity |
arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle...
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arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle and joint pain; chills; low grade fever 99.7; sore throat; congestion; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 3 ug/ml) Batch/lot number: EL1284, on 29Dec2020 12:33 single dose on left arm for COVID-19 immunization. Medical history included Blood pressure high which diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42; hemochromatosis diagnosed about 25 years ago; Arthritis; Cluster headaches; low thyroid and she didn't take medication for this, it wasn't low enough; COVID-19 in Mar2020. Concomitant medication was none. The patient received the Pfizer covid vaccine yesterday (29Dec2020) and she called the line to report the side effects today. She said she had covid around the Easter time and donated her plasma also for antibodies. She said after getting the vaccine yesterday she was feeling worse, have a really bad headache, teeth ache, arm was hurting woke up due to that in the night, really bad headache, muscle and joint pain, chills , low grade fever 99.7 , sore throat and congestion. The patient received the vaccine through work, and was not prescribed it from a provider. She had her shot at 12:33PM yesterday (29Dec2020), after lunch. Her vaccine was given to her at the hospital where she worked, which was not a military hospital. Her side effects were that she developed a headache, also her teeth were aching, and then last night around 04:00AM in the morning she woke up with a very sore arm and worse headache. She said she also had muscle and joint pains, chills, and fever. She said now she still had a headache, and still didn't feel good. Treatment received for the events included Ibuprofen and Tylenol. Ibuprofen was clarified to being generic Ibuprofen prescription in a pharmacy bottle with EXP 3 09Mar2021 and NDC: 67877032005. She said that the strength of this medication is 600mg, and she just took one last night by mouth at about four in the morning. She says she also took Tylenol before bed, 500mg, this is the name brand product. UPC/LOT/EXP: unknown, she didn't have it with her she said it was in date and was brand new, in to go packs. She said that her teeth aching was gone, she still had her headache, muscle pain, fever, and her arm hurt. She said she did take another Tylenol a half hour ago or 45 minutes ago. Her low grade fever temperature was 99.7 degrees Fahrenheit. She had COVID-19 before, she tested positive for COVID at Easter time, this was in March, they did a PCR nasal swab. She had two positive tests and then a negative test because they had to retest her to get plasma, she had to be negative before she could get plasma. She also had an antibody test a couple months after she had COVID, that showed she had 27 antibodies. She had COVID, then a couple of weeks later she gave plasma, and then a few weeks later had the antibody test that showed she had the 27 antibodies. The outcome of teeth ache was resolved. The outcome of headache, muscle pain, fever, and her arm hurt was not resolved. The outcome of other events was unknown.
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| 68 | 2021-01-07 | tremor |
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he...
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1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
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| 68 | 2021-01-07 | pain in extremity |
Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day af...
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Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day after first injection, I began with chills, headache, fatigue, body aches. By the second day after initial dose, I began with mucus cough and same symptoms with chills, headache, fatigue and body aches. I took Tylenol, cold and cough medication. It is the third day after injection, symptoms same, but slightly better, still extreme fatigue and body aches and chills and I took an Proventyl inhaler as needed. Note, I do not take Proventyl inhaler on a regular basis, I just felt the need as I was beginning to have a lot of bronchial mucus. The inhaler seems to help. I am waiting it out and did not contact my family physicians. I am hoping I will feel better soon. Still taking OTC medications and Tylenol, fluids and rest.
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| 68 | 2021-01-07 | pain in extremity |
In the evening on the day of the vaccine and the following day my arm was sore and then my entire bo...
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In the evening on the day of the vaccine and the following day my arm was sore and then my entire body. Body was so sore that I had to take med to sleep. It is early Friday morning now and I have been so tired and hurting that I have slept most of the week (4 days). I don't often take immunizations as they kick in my rheumatic/psoriatic arthritis so badly and I hurt so badly and can't do anything. I was hoping that this immunization would be different as it's action is supposed to be different. I am still planning on getting the second shot as it is so important:especially due to my age and other conditions.
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| 68 | 2021-01-07 | pain in extremity |
Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, c...
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Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, cough, with lots of mucus and cough. Taking Tylenol, OTC cold medication and inhaler as needed. Waiting it out with rest, fluids, medication.
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| 68 | 2021-01-08 | numbness, tingling |
Daughter called 30 Min after patient left facility (about 1 hr after vaccine) reporting Left side of...
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Daughter called 30 Min after patient left facility (about 1 hr after vaccine) reporting Left side of her face was numb and tingling but was easing. MD previously approved vaccination. Patient's daughter was instructed to monitor patient and call MD if symptoms worse.
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| 68 | 2021-01-09 | feeling hot |
Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), ab...
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Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)
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| 68 | 2021-01-11 | pain in extremity |
Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 ...
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Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 hours Fever has continued in the afternoons
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| 68 | 2021-01-12 | tremor |
Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stom...
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Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stomach pain, diarrhea Still experiencing fever and diarrhea.
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| 68 | 2021-01-12 | muscle spasms |
Lower extremity muscle cramping (not near the site of injection) approximately 18 hours post-vaccina...
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Lower extremity muscle cramping (not near the site of injection) approximately 18 hours post-vaccination.
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| 68 | 2021-01-12 | breast pain |
Pain in the breast/all of a sudden it was just like a shot stinging pain because it's on the same si...
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Pain in the breast/all of a sudden it was just like a shot stinging pain because it's on the same side that I had the injection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142, exp. date: 31Mar2021), via an unspecified route of administration on the arm on unknown date at SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer from 2015 (reported as about 6 years ago and that doesn't have anything) and thyroid disorder (reported as thyroid). Concomitant medication included levothyroxine (LEVOTHYROXINE) for thyroid. On an unknown date, the patient had a side effect of pain in the breast and all of a sudden it was just like a shot stinging pain because it's on the same side of the injection. The patient mentioned that it didn't happen that day of injection, it happened the next night and also then the night after but not as bad. The patient was going to her gynecologist next Tuesday (in 2021) and will check her. Outcome of the event was unknown.
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| 68 | 2021-01-13 | cold extremities | 1) Ice cold toes & feet, sweat in toe area of socks 2) confusion, 3) chills |
| 68 | 2021-01-13 | pain in extremity |
I just had a sore in the left arm the next day; This is a spontaneous report from a contactable Nur...
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I just had a sore in the left arm the next day; This is a spontaneous report from a contactable Nurse (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date not reported), intramuscular on the left arm on 28Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included allergies to PCN/Sulfa. Concomitant medications included calcium and an unspecified allergy pill. The patient reported that she just had a sore in the left arm the next day on 29Dec2020 and there were no other problems. No treatment was given for the event. The event was reported as non-serious. The patient had no prior COVID vaccination and did not test positive for COVID post vaccination. The patient recovered from the event on an unspecified date.
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| 68 | 2021-01-13 | pain in extremity |
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the fi...
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Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
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| 68 | 2021-01-13 | pain in extremity |
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal...
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Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
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| 68 | 2021-01-17 | migraine |
Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day ...
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Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day 2. Same symptoms to a lesser extent Day 3. Day 4 no symptoms.
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| 68 | 2021-01-18 | pain in extremity |
Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The in...
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Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The injection site was tender to touch and a dull ache went down my left arm to the fingers. The symptoms persist into the day after the vaccination.
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| 68 | 2021-01-18 | pain in extremity |
Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection ...
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Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection site is tender to touch. I was unable to lay on this arm as I went to sleep. I also developed a dull ache down my left arm to my fingers. These symptoms remain in the day following the injection
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| 68 | 2021-01-18 | weakness |
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h...
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Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
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| 68 | 2021-01-19 | numbness, tremor |
20 minutes after injection , middle finger right hand started jumping for approximately 10 minutes,...
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20 minutes after injection , middle finger right hand started jumping for approximately 10 minutes, getting less vigorous with time. 1-10-21 stared having tremors every 2-3 minutes in both hands, left leg and occasionally in right leg. Left leg and bottom of left foot numb feeling off and on.
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| 68 | 2021-01-19 | numbness | MINOR NUMBNESS IN RIGHT PALM. RESOLVED WITHIN THE 15 MINUTES |
| 68 | 2021-01-19 | pain in extremity, numbness, tingling | Severe L arm pain, L face tingling, numbness, and warm to touch including eye area and eye swelling |
| 68 | 2021-01-20 | burning sensation, pain in extremity |
3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as...
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3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as throbbing 5/10. Also c/o nausea. O2 97% on room air, HR 86; EMT on site in attendance. 3:24 BP 206/118 on Lt upper arm taken per EMT 3:30 BP 182/118; HR 118 per radial pulse. States pain now 2/10 is is a dull pain to a burning warm sensation. 3:35 O2 98% r/a, HR 68 3:40 BP 132/80 HR 66, O2 97% r/a. Patient states she is feeling better. Patient decided to go home accompanied by husband to private vehicle. EMT recommended to patient the she f/u with doctor is she feels worse. Ambulated with husband.
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| 68 | 2021-01-21 | pain in extremity |
Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand ...
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Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand - unable to open our close hand. Lasted until next morning.
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| 68 | 2021-01-22 | weakness, tremor |
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudde...
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30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven). This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered. This series of events recurred 6 days later, on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
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| 68 | 2021-01-23 | cold extremities |
Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer ...
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Patient received her vaccination around 730 am on her left deltoid. Patient approached the observer around 735 am about concern of dizziness. Patient also states that she has cancer. Patient was then escorted to the bed stretcher. Patient vital signs were taken in which her BP was 181/91, O2 sat 79%, HR: 104. Patient was also noted to be anxious and states that she does not take any oxygen at home. Patient was encouraged to relax and lay down comfortably on the bed stretcher. Patient was cold upon touch. There was an attempt to warm the patient but the patient was still cold upon touch. Vital signs were taken again in which her BP was 179/84, O2 sat fluctuating between 80-90's. The decision was then made to take the patient to the emergency department.
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| 68 | 2021-01-23 | feeling hot, flushing |
at 545 PM patient reported feeling warm and flushed vitals at 550 PM 192/88 O2 97 HR 72 given IM B...
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at 545 PM patient reported feeling warm and flushed vitals at 550 PM 192/88 O2 97 HR 72 given IM Benadryl 50mg left deltoid at 552 PM repeat VS @ 6 PM manual BP 164/82 and rest of VS WNL monitoring for 10 mins by nurse and paramedic VS @ 610 PM 97%O2 68 HR 150/86 BP on D/C stable and will monitor, to go to ED if SOB, or any signs of distress develop
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| 68 | 2021-01-24 | flushing |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after rec...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after receiving the vaccine individual developed itchy flushed on face cheeks, chest, and back. She was given Benadryl 50 mg IM in Right arm at 3:55 pm. 4:12 pm the itchy skin was less intensified and vitals were stable. Individual went home with family
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| 68 | 2021-01-24 | pain in extremity, numbness, tingling |
My reaction did not require medical attention, but I happened to have an appt. with my doctor and me...
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My reaction did not require medical attention, but I happened to have an appt. with my doctor and mentioned it to her. She thought I should mention it to you in case it is part of a larger pattern. I had normal reactions of arm pain and headache (not serious) since I had the shot. I have also been experiencing sporadic numbness and tingling in my arm down to my fingers. It does not last long but it comes and goes. It has been three days since the shot and all symptoms have decreased.
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| 68 | 2021-01-24 | weakness, pain in extremity |
Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aph...
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Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards. In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse. With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission. On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
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| 68 | 2021-01-25 | pain in extremity |
About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hur...
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About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hurt to lift my arm. Also had some slight nausea and headache. Took Ibuprofen helped some. Next day still felt off, arm still extremely sore, body aches, headache, fatigue. I continued with the Ibuprofen alternating with Tylenol. Finally felt better by Sunday and was able to return to work on Monday.
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| 68 | 2021-01-25 | weakness |
Chill, headache Saturday and Sunday the 1 /24/21 and 1/25/21. Coughing began on Sat the 24 along wit...
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Chill, headache Saturday and Sunday the 1 /24/21 and 1/25/21. Coughing began on Sat the 24 along with terrible aches through out my whole body. Very weak and tired. Today is Tuesday, 1/26/21 and my symptoms are the same. My 95 year old mother had a bad cold and I thought I had gotten a cold from her. Now I believe it is a reaction from my first covid shot. No symptoms til 3 days after injection. My aches throughout my whole body have only been this bad when I was diagnosed in 1994 with derma-polymiostis. An arthritis that attaches the skeletal muscles in your whole body. A question is: What should I possibly expect when I get my 2nd covid injection? How long are these current symptoms going to last?
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| 68 | 2021-01-25 | weakness |
Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept thro...
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Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept through the night and awake in am without symptoms. Getting out of bed sudden drop in BP with weakness, feeling faint, nausea, sweating. Drop in BP to 68/52. Unable to go to work. Improved with upright resting in am with BP at 10:30 am 119/69 (low as my usual BP averages 130's/mid 80's). Still slightly nauseous. Able to have toast and tea. Felt better as am progressed and able to drive to work at 11:45 am. Worked until 6 pm without further symptoms.
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| 68 | 2021-01-25 | tension headache |
Mild to medium headache. Not particularly quick onset, Felt more like tension headache than like mig...
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Mild to medium headache. Not particularly quick onset, Felt more like tension headache than like migraine type. Accompanied by stiff neck/shoulders. Took no medication - headache and stiffness continued into evening at mild level. Home thermometer showed 98.7 around 8:00 pm ( I am usually 96.5 to 97.5 ) No problem sleeping that night and headache and 'fever' was gone upon awakening. Similar symptoms ( no fever) developing late afternoon of 1/26/2021 - will input another report if different outcome.
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| 68 | 2021-01-25 | tingling, flushing |
PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY ...
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PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY DISTRESS, SHORTNESS OF BREATH OR CHEST PAIN: HEART RATE 62: 02 99% ON ROOM AIR: RESPIRATIONS 18: LUNGS CLEAR AND NO STRIDOR NOTED: PATIENT PROVIDED WITH WATER: PATIENT STATES SHE "SHE FEELS PRICKLEY ON THE FACE AND HEAD."
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| 68 | 2021-01-25 | weakness |
Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vac...
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Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21 @ 0630, at 2030 developed generalized aching, chills, weakness and sleepiness. Woke up at 0300, went to bathroom and passed out returning to bed. Awakened soaked in perspiration. Had dry heaves and 1 loose stool. Felt weak and sleepy until 0700, then felt mostly normal. Symptoms relieved by 1000. No other symptoms after that".
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| 68 | 2021-01-26 | flushing |
.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No ...
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.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No outward sign. Symptoms continued throughout the rest of the day. Mild headache, some nausea. No difficulty breathing, no fever, no hives or rash. General uneasy feeling. Next morning awoke with "fullness "in ears, with some ringing. Facial symptoms would come and go. On Sunday, two days after vaccine, I felt much better, facial symptoms better, ears still felt plugged. Could ear fine. On Monday , symptoms pretty much gone. I was in contact with primary physician through email/phone message. No treatment was necessary.
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| 68 | 2021-01-26 | nerve pain, weakness, muscle spasms |
1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilita...
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1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilitating pain from mid front center to center back at level of last rib on rt Diagnosed w Shingles, no rash or blisters -severe debilitating nerve pain . Valacyclovir 2 grams a day for seven days 1/27/21 no rash or redness ever developed but nerve pain continues, skin still sensitive to touch, less stabbing sharp debilitating pain to now an aching nagging pain from mid center in a semi circle to mid back.
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| 68 | 2021-01-26 | flushing, feeling hot |
Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I w...
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Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I was observed for an extra 20-30 minutes. Vital signs were taken. Blood pressure up slightly, heart rate slightly elevated Sent home without treatment but recommended I should take antihistamine at home. I took a 12-hour allegra about 12pm and a single 25 mg benadryl tablet at bedtime. The symptoms lasted about 3-4 hours before resolving. They did not get worse from the immediate reaction. Recommended contacting my family physician for advice of what to do before 2nd shot which is scheduled for Feb. 15, 2021
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| 68 | 2021-01-27 | tremor, muscle twitching, tingling |
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio...
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Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-28 | tingling |
2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing...
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2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing and my pressure started going up. After 3-4 days, my hairline started receding slightly on the sides of my scalp in the front. This continued each day and I had to increase my blood pressure medicine and double the dose because it was getting so high. I was anxious and upset and am afraid to take the second dose because I feel that I will get a worse reaction, and am frightened.
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| 68 | 2021-01-28 | pain in extremity |
On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, ...
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On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm. When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything. As the day went on I was just mad about everything, I began to drink lots of water and tried to exercise to get the swelling down. About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable then. I am still swollen and still angry and it is Friday.
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| 68 | 2021-01-28 | tremor | Shakes, tongue and lip sweeping, pain in stomach and headache |
| 68 | 2021-01-28 | pain in extremity | shore arm, fever chills body aches nausea and vomiting |
| 68 | 2021-01-30 | flushing, tingling |
Posterior head and neck tingling and warmth and flushing in cheeks. Resolved at after given 50 mg of...
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Posterior head and neck tingling and warmth and flushing in cheeks. Resolved at after given 50 mg of Benadryl P.O. Advise to follow up her PCP
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| 68 | 2021-01-31 | nerve pain |
About 6 hours after receiving the shot, I began to have severe lower back pain (9 pm). By Midnight...
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About 6 hours after receiving the shot, I began to have severe lower back pain (9 pm). By Midnight, I had excruciating nerve pain shooting across my lower back along with the muscular back pain. I was up all night in pain. I did not take anything for the pain for fear of comprising the vaccine. the next day pain was worse, called my doctor and was told I could take Tramadol, 50 mg. It did nothing for the pain until I took another dose. Pain got worse and I was unable to get myself out of bed, or from a sitting position without my husband pulling me up. My muscles were not working, or it was just too painful, I'm not sure. Could barely walk. This lasted for 3 full days and then the pain gradually started to subside. Took a full week for back pain to totally go away.
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| 68 | 2021-01-31 | pain in extremity |
Chest pains 5 days after. Never had like that before And big red welt about three inches by 2 in...
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Chest pains 5 days after. Never had like that before And big red welt about three inches by 2 inches 2 weeks later. And arm is now aching
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| 68 | 2021-01-31 | pain in extremity |
PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT L...
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PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT LIFT OR USE A SPATULA TO EVEN TURN EGGS OVER IN FRYING PAN. STARTED ON SUNDAY 1/24/21 3 DAYS AFTER RECEIVING FIRST DOSE OF VACCINE. PAIN MINIMAL AT INJECTION SITE, BUT PAIN ALSO OCCURS IN SHOULDER. UNABLE TO RAISE ARM ABOVE HEAD OR EVEN STRAIGHT OUT. WAS SEEN IN URGENT CARE. PROVIDER REPORTS NO SIGNS OF PROBLEMS AT INJECTION SITE. NO REDNESS, NO SWELLING, NO NECROTIC TISSUE.
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| 68 | 2021-02-01 | pain in extremity |
101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm. Symptoms started early morni...
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101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm. Symptoms started early morning of 01/29/2021 and lasted until midday on 01/30/2021.
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| 68 | 2021-02-01 | feeling cold |
Developed a slight fever late at night the same day f the vaccine. Had chills, was freezing at night...
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Developed a slight fever late at night the same day f the vaccine. Had chills, was freezing at night, had lots of blankets, electric heater could not feel warm. Did not take anything. Next morning woke up and still felt a little bit of general malaise, took Tylenol and that is it, it was all over in 24 hours.
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| 68 | 2021-02-02 | pain in extremity |
1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarr...
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1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarrhea and stool was black for a few eliminations. Fever, Chills, Nausea, arm sore, headache, fatigue, body ache 1.25 ~ symptoms continued 1.26 ~ more black stool. Dr. advised me to go to ER. They did find blood in stool. 2.1~finally had normal bm and started to feel better
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| 68 | 2021-02-02 | hypersensitivity of all senses | hyperesthesia, myalgia, chills, fatigue, headache |
| 68 | 2021-02-03 | migraine |
2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later devel...
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2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later developed headache which increased in intensity and eventually triggered a migraine, severe dizziness making it impossible to sit/stand, muscle aches,nausea. no temperature or chills. The headache lasted all day lasted all day Friday and decreased in intensity by Saturday. With rest, the dizziness resolved by Friday evening. The muscle aches remained mildly for a few days.
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| 68 | 2021-02-03 | weakness |
Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimm...
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Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
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| 68 | 2021-02-03 | pain in extremity | Hives arm soreness and a headache |
| 68 | 2021-02-03 | pain in extremity |
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he...
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Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
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| 68 | 2021-02-04 | pain in extremity, tenderness |
Patient reported that she received her 2nd COVID vaccine. She reports no symptoms after her first va...
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Patient reported that she received her 2nd COVID vaccine. She reports no symptoms after her first vaccine injection. Both injections were in her left deltoid. On the evening of 2/2/2021, she started having some aching in the left arm. She noticed that her left axillary lymph node is swollen and painful. She states the swelling is very significant and it hurts, not just tender to touch. Doesn't look red or feel warm. No fever. She took ibuprofen 400 mg. Patient advised to follow-up with her PCP.
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| 68 | 2021-02-04 | weakness |
The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ...
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The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
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| 68 | 2021-02-05 | feeling cold |
Early morning after vaccine started with headache then nausea and chilling. Chilling all day and ev...
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Early morning after vaccine started with headache then nausea and chilling. Chilling all day and evening Fever must have broke about 24 hours or so after with breaking out in a sweat. Symptoms just keep getting worse as the day progressed . Almost 24 hours after the bones just hurt. Today, 2/6/21, two days after vaccination still have nagging headache
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| 68 | 2021-02-05 | pain in extremity |
Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm...
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Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm soreness from 5 hours after vaccination until 36 hours after time of vaccination
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| 68 | 2021-02-05 | weakness |
Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 a...
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Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 and slept most of the day. Today, 2/6/2021 I feel fine. No further symptoms and no further need for Tylenol.
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| 68 | 2021-02-07 | migraine |
Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migr...
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Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migraine (has history of. Assisted to private location and removed some of her winter garments to cool her. She also took in water as she had not drank much that day she stated. Ice pack to the back of neck also applied. Vitals taken and wnl. Affter approx 10 min patient states headache resolved and was feeling slightly better. Observed till symptoms resolved. Denies any resp symptoms during entire process. No swelling anywhere on person.
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| 68 | 2021-02-07 | cold sweat, weakness, numbness |
Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, tran...
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Felt week and clammy, reported trouble swallowing then numbness in face; rapid response called, transferred to ED. 1:43: HR: 74, RR: 16, O2: 97%, BP: 112/66 END Other daily meds: Protonix, Simbicort, Eliquis(Unable to type on 2nd page)
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| 68 | 2021-02-07 | weakness |
Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ...
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Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.
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| 68 | 2021-02-07 | unresponsive to stimuli |
Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respi...
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Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respiratory depression/distress. At this time it is unclear etiology of presentation. However patient is slowly becoming more alert/awake.
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| 68 | 2021-02-07 | weakness |
Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat ...
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Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat Dizziness and weakness Observed on site by EMS and nurses for approximately 1 hour
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| 68 | 2021-02-07 | numbness |
her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in pa...
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her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.
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| 68 | 2021-02-07 | burning sensation |
joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection ...
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joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation . Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001. There were no concomitant medications. The patient experienced feeling sick on 13Jan2021 with outcome of recovering , injection site pain on 13Jan2021 with outcome of recovering , headache on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen on 16Jan2021 with outcome of recovering , joint pain on an unspecified date with outcome of recovering , burned on 13Jan2021 with outcome of recovering. The patient received ibuprofen 400 mg to treat headache, muscle pain, joint pain. The patient is not sure if LOT number is EL1283 or EC1283. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-02-07 | pain in extremity |
pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still ther...
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pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still there); unable to open & close left hand until next morning; Headache; occasional chills; fever; fatigue; Mild facial swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Medical history included allergies to Sulfa. The patient did not have other chronic health conditions. Concomitant medications included turmeric [curcuma longa rhizome], and ashwagandha. The patient previously took doxycycline and experienced allergies. On 21Jan2021, the patient had mild facial swelling 20 minutes after inoculation, at 14:30 the patient had pain down left arm to wrist and hand (still there), unable to open and close left hand until next morning, headache, occasional chills, fever and fatigue. The patient did not receive treatment for the events. The events were considered non-serious. The patient was recovering from the events.
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| 68 | 2021-02-08 | weakness | CHILLS, FEVER UP TO 101 DEGREES, BODY ACHES, NAUSEA, WEAKNESS LASTED FOR 24 HRS THEN WEAKNESS |
| 68 | 2021-02-08 | pain in extremity |
It has now been 8 days since my first dose of Pzifer vaccine (February 1, 2021) and I have been exp...
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It has now been 8 days since my first dose of Pzifer vaccine (February 1, 2021) and I have been experiencing painful, aching quads in both legs and groin area. Have taken Advil to relieve pain and still feel intense throbing legs and especially the R groin area. On a scale of 1-10 it is a 7-8. Ten years ago I was diagonosed with Osetomyletics and the blood infection landed on my pelvic area and I was unable to walk . Spent a week in the hospital and infectious disease doctors put a port in my chest an for 1 month was on heavy duty antibotics to rid the infection. I am experiencing the pain in the same area of the groin, but now the quad muscles are equally painfully. I am concerned as it has now been 8 days and there is NO relief to my pain and I am assuming it is a side effect of the vaccine? Please adivse.
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| 68 | 2021-02-08 | difficulty speaking |
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain...
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Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache. Early evening I developed hoarseness and trouble breathing. Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better. I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
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| 68 | 2021-02-08 | pain in extremity |
My arm was sore pretty much from the beginning and is still sore today, February 9th. It's not terri...
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My arm was sore pretty much from the beginning and is still sore today, February 9th. It's not terribly painful but uncomfortable, and I have lost strength in this arm.
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| 68 | 2021-02-08 | seizure |
Patient had multiple seizures that were treated with 5 mg Versed intranasally and 5 mg IVP. Seizures...
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Patient had multiple seizures that were treated with 5 mg Versed intranasally and 5 mg IVP. Seizures broke and weas transferred to Hospital
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| 68 | 2021-02-08 | flushing, tingling, numbness |
Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair...
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Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair and assisted to private location. C/o eyes feeling funny and tearing. next c/o chest pressure and tingling started down legs. Breathing labored and flushed skin. Epi administered and assisted to ER.
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| 68 | 2021-02-08 | facial paralysis | Right face drooping. Diagnosed as Bell's Palsy. |
| 68 | 2021-02-08 | migraine |
Severe migraine and head pain. Onset 24 hours after vaccine. Generalized itching from top of head ...
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Severe migraine and head pain. Onset 24 hours after vaccine. Generalized itching from top of head to toes. Both lasting about 48 hours
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| 68 | 2021-02-08 | weakness, pain in extremity |
suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support her...
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suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional. A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date. Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship. However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-02-09 | weakness, pain in extremity |
Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 P...
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Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
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| 68 | 2021-02-09 | numbness, tingling |
Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head a...
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Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation; Stinging feeling in sinus cavity; This is a spontaneous report from contactable consumer (patient) A 68-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot#292673 on left deltoid (reported as left shoulder) on 25Jan2021 11:21 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes from 11Sep2001 and ongoing , ongoing cardiac pacemaker insertion Put in about 7 years ago , ongoing blood cholesterol increased Diagnosed about 24 years ago , ongoing blood triglycerides increased. She is allergic to statins. Concomitant medication included alirocumab (PRALUENT) 1 mL at 1ml injection every 14 days for High cholesterol (Injection on side or top of her leg. She has been taking for about 4 year).The patient experienced headache on 25Jan2021 with outcome of recovered , funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation on 25Jan2021 with outcome of unknown , stinging feeling in sinus cavity on 25Jan2021 with outcome of recovered , pin prickly feeling in different areas of her body on an unspecified date with outcome of unknown. Clincial course reported as follows:She got the first dose of the vaccine today and while she was sitting in the observation area, she started getting a headache. It was close to noon and she just blew the headache off since she was a diabetic. She started getting a funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation. When the feeling hit her sinus cavity, it was like a stinging. She started drinking water and she had lunch. Within an hour it started getting better and within 3 hours it was a lot better. She has a pin prickly feeling in different areas of her body but did not have the numbness sensation. She tried to report this online. She only had one virtual visit with her doctor. Treatment: declines any, she was drinking plenty of water to try and flush some it out of her system.
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| 68 | 2021-02-09 | tingling, burning sensation, discomfort, feeling hot, muscle spasms, pain in extremity |
The heat from the elbow (not clarified further), besides the knees and the ankle and the toes.; pain...
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The heat from the elbow (not clarified further), besides the knees and the ankle and the toes.; pain in knees, ankles and feet and lower leg with the cramping and tingling, mostly tingling and burning like a radiating pain; discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; I experienced discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; Also occasionally pain in hips, elbows and other joints/Pricking pain in my left hip/mild burning radiating from around the joints; cramping in my left footmy knees, my ankles and my feet, the lower leg felt cramp; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose bnt162b2 (BNT162B2, lot number: EL1283), via an unspecified route of administration, at arm left, on 12Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included blood cholesterol increased, chronic productive cough, known allergies to sulfa, sinus disorder. Is pregnant: No. Concomitant medication included mometasone furoate (FLONASE) for sinus, ascorbic acid (VITAMIN C). No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. 4 days after receiving vaccine, on 16Jan2021 12:00 AM the patient experienced discomfort with burning, tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine and have continued for more than 30 hours now , Also occasionally pain in hips, elbows and other joints. As of 23Jan2021, it was reported the patient experienced burning, tingling sensations around ankles, knees and lower leg. Yesterday started feeling same thing, the feet, toes, around ankles, up legs and around knees. Sometime it feels like it's a mild burning radiating from around the joints and in the lower leg too. It is mainly her feet up to above the knees, burning, tingling, radiating. Sometimes have occasional pain little bit in some of the other joints, this is a little bit more than joint pain. Consumer stated, that she received the first dose of this Pfizer Vaccine on 12Jan2021. And about four days after during the night she was feeling some kind of burning, tingling sensations around ankles and knees and lower leg. It went away it lasted maybe about 4 hours, but then yesterday which is on the 22nd started in early afternoon started feeling the same thing, the feet and the toes, around ankles, up the legs and around the knees. Sometime it feels like it's a mild burning radiating from you know around the joints and in the lower leg too. It is mainly feet up to above the knees, burning, tingling, radiating. And sometimes I have occasional pain in just a little bit in some of the other joints you know that's been going on after the vaccine occasionally. The heat from the elbow (not clarified further), besides the knees and the ankle and the toes. The patient called this number because that is the number that was on the page to say if there was anything to report and then you know she was wondering if this is, she saw that some of the side effects could be joint pain but this is a little bit more than joint pain. So, she was wondering if there is anything. She mean she was going to see doctor on Monday, this has been going on for more than 30 hours now, but she was wondering if there is any advice in this. Pricking pain in her left hip started on 12Jan2021, Little bit of cramping in left foot started on 12Jan2021, Knees, ankles and feet, the lower leg felt cramp, like a radiating pain started on 16Jan2021. Consumer stated, initially, when she just got the vaccine, she felt a little prick in her left hip, like a little pain but it did not stay, pricking pain in her left hip. A little bit of cramping in her left foot, but it went away. So she did not think anything of it. 4 days later, on the 16Jan2021 (later confirmed), during the night her knees, her ankles and feet, the lower leg felt cramp, like a radiating pain. It was not very severe, like a mild pain in the knees and the lower legs and feet, a type of tingling but it went away. Pain was like a radiating, sort of burning but it was mild burn. Date when started experiencing pain is on the same day, 12Jan2021. Lab work was no. Treatment was no, because it was transient but afterwards what concerned her is on Friday which is the 22nd, she started experiencing a pain in knees, ankles and feet and lower leg with the cramping and tingling, mostly tingling and burning like a radiating pain. The whole, above her knees, down the lower leg, ankles, feet and toes and it continued up till last night and so more than for 30 hours that is what concerned her. That is why she called last night. The outcome of the event feeling hot , pain in extremity, muscle spasm was unknown, of the other events was not recovered.
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| 68 | 2021-02-10 | tremor | Uncontrollable shaking chills, fever, headache stomach pain |
| 68 | 2021-02-10 | pain in extremity, weakness |
arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; f...
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arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-02-11 | pain in extremity |
I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wedn...
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I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick . I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I couldn?t eat or drink the whole time), fever and chills. The bouts of vomiting fever and chills came in three through the day. I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday. I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed. Now it?s Friday morning (5:30 a.m.) and I feel completely well again.
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| 68 | 2021-02-11 | pain in extremity |
increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2...
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increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2-3 years. I took my prescribed blood pressure medication prior to bed time. This morning b/p is in normal range. other side effects: sore arm, leg and hip pain. This am has improved.
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| 68 | 2021-02-14 | flushing |
Patient received 1st dose of Pfizer COVID-19 Vaccine around 3:30 pm on February 13th and was asked t...
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Patient received 1st dose of Pfizer COVID-19 Vaccine around 3:30 pm on February 13th and was asked to wait 30 minutes for observation due to previous history of anaphylaxis to peanuts and latex. Around 3:43pm patient stated she felt dizzy and light headed and appeared flushed. Her blood pressure taken at the onset of symptoms was 146/72 and patient stated she had chest pain (7/10 on pain scale). She stated she felt the same way when she had previous anaphylaxis so an epipen was administered and 911 was called. About 10 minutes later there was no improvement so a 2nd epipen was administered and she left with EMT. We have been unable to reach for follow up.
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| 68 | 2021-02-14 | tingling, pain in extremity |
Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand ...
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Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand and fingers
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| 68 | 2021-02-14 | facial paralysis |
right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable ...
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right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El8982), via an unspecified route of administration on 29Jan2021 09:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: El3246) received on 08Jan2021 at 03:00 pm on left arm for COVID-19 immunization. The patient experienced right side of face drooping, diagnosis as bell's palsy on 31Jan2021 06:00 with outcome of not recovered. Treatment received for the event included prescriptions. This event resulted in emergency room/department or urgent care. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination.
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| 68 | 2021-02-15 | pain in extremity |
68-year-old female evaluated for painful movement of her extremities. Patient reports that her sympt...
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68-year-old female evaluated for painful movement of her extremities. Patient reports that her symptoms started the day after receiving the Pfizer COVID-19 vaccine at pharmacy. Patient was admitted. Patient has been evaluated by Neurology, Rheumatology and the Ortho-Spine Service. Symptoms improved with prednisone. Although unclear, a diagnosis of polymyalgia rheumatica was being considered due to elevated CRP (inflammatory marker). Relationship to vaccine administration is also unclear. Pt with Hx of arthritis, COPD, CAD, CHF, and HTN received first dose of Pfizer COVID-19 Vaccine. Within 24 hours of vaccine administration, pt went to hospital c/o of painful movement of extremities. Pt was treated with prednisone and symptoms improved. She was evaluated by multiple specialties including neurology, rheumatology and orthopedics without a clear diagnosis. Her CRP was elevated to 17.2 mg/dL and Sed Rate to greater than 130 mm/hr and reactive ANA titer. Total CK was normal at 23 IU/L. Rheumatology wrote this is highly suggestive of COVID-19 vaccine induced polymyalgia rheumatica which has been reported with other vaccines but not with COVID-19 vaccines.
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| 68 | 2021-02-15 | pain in extremity, tingling, hot flush |
After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days aft...
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After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days after I had itching, prickly tingly sensations everywhere, especially arms, legs, neck, and back. These lasted for 11 days after that, finally subsided. But then I got dose 2, and had sore arm, and next day, aches in muscles, low fever, congestion but all mild. Took ibuprofen and went away after 24 hours. 5 days later, the itching, tingling started up again and was more intense and everywhere. Have had some redness, swelling, red bumps in itchy areas, they come and go. Worse when I have hot flash. Itching is keeping me awake along with anxiety and restlessness. Hope this won't last for another 10 days, very uncomfortable.
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| 68 | 2021-02-15 | numbness | tip of nose was numb, top lip, chin, forehead cheeks were also numb, eyes felt different |
| 68 | 2021-02-16 | nerve pain |
lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pa...
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lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pain; Her husband had to pull her out of the bed because she felt she had no muscle activity; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EL8982), via an unspecified route of administration in the left arm on 17Jan2021 at 15:00 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included benign spinal cord tumor from 1987 and unspecified if ongoing (a lot of bone had to get cut), lot of scar tissue (wonders if it is a weak spot) from an unspecified date and unspecified if ongoing, thyroid removed in 2015, neurosurgery (to remove the benign spinal cord tumor) on an unspecified date, thyroid on an unspecified date and unspecified if ongoing and cholesterol from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing levothyroxine (strength: 125 ug) taken for an unspecified indication at 125 ug, 1x/day, ongoing pravastatin (strength: 40mg) taken for cholesterol from an unspecified date at 40mg, 1x/day and ongoing multivitamin. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID-19 vaccine. The patient experienced lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity, all on 17Jan2021. The patient called and stated "she had a very extreme reaction from the first dose of the vaccine, which she had last Sunday the 17th. It began with lower back pain, which did not alarm her too much but then it went in to nerve pain. By the end of the evening, by about midnight, she was in what she considered to be excruciating pain. She changed positions and it was hitting the nerve and she was getting pain and having muscle pain. She was up all night because she could not sleep with the pain. Monday and Tuesday were very excruciating, and she took Tramadol Monday after consulting with her doctor. She did not get any relief until Wednesday, 3 days after the shot. Even today she had some lower back pain, but it is way better than it was. It was improving from Wednesday to today but Sunday to Wednesday was excruciating since it was giving her nerve pain. Her husband had to pull her out of the bed because she felt she had no muscle activity. In 1987 she had a spinal cord tumor and a lot of bone had to get cut and she stated she was sure she had a lot of scar tissue and wondered if it was a weak spot. She stated this could be an isolated incident, but she really thought she had another tumor at first until it started dissipating on its own. She stated she did not know anyone who has had this reaction and asked if it was safe/advisable to get the second shot? She stated she was afraid of the permanent nerve damage but as long as it cannot do anything permanent, she wanted to get it. Was this a reported symptom? Has anyone ever gotten paralyzed? After verbal response she stated she will talk with her doctor and maybe see a neurologist." Upon follow-up the patient called and stated "I had two questions actually. I received the Pfizer Vaccine yesterday and last night I started with the excruciating back pain, my lower back. I do not know if it was coincidence or not because I have back trouble before. I did not do anything to throw my back out. However, I was told it would be okay to take Extra Strength Tylenol. I took 4 Tylenol within like 3 hours period because it was not working. I took another two this morning. Tylenol was not doing anything at all for the pain relief. My question was, I have a prescription of Tramadol which I took for pain for different reason, but I have it. First of all, I hope by taking the Tylenol yesterday that it did not interfere with the efficiency of the vaccine. My other question is can I take the Tramadol now? Since the vaccine was 24 hours ago would it interfere with efficiency?" Upon follow-up the patient called to report that "she went to her chiropractor late Wednesday afternoon, and he did some stretching, but her spine was not out of alignment, so he felt her pain was due to the vaccine. Stated that it was not until her back started getting better on Wednesday without treatment that she first started to attribute it to the vaccine, because her back just did not get better on its own. Stated that the first day she did not take anything for the pain because she was worried that it might interact with the vaccine or its effectiveness, but the next day she began taking Tramadol pain meds that she already had in the house for her knee. Stated that the pain in her back was so bad, that even a strong medication like the Tramadol did not take away the pain. It did not help all that much, she had to take a 2nd 50mg tablet 3 hours later. Should she get the second dose of the vaccine? Could it possibly do more nerve damage; could she be jeopardizing her nervous system? Have there been any other reports about this? Stated that other people had minor things like, one person reported being tired for a couple days, and another person reported body aches like with the flu, but after 3 days they both were fine. Her husband was 74 and had the vaccine and he had no side effects." The events prompted a visit to her physician. The patient stated that "this was the first day since Sunday that she was feeling almost 100%. She had the pain from Sunday evening all the way until noon on Wednesday; at that point it improved about 50% and she had some mobility." The outcomes of the events lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity were all recovering/resolving.
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| 68 | 2021-02-16 | numbness |
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ...
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out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-02-17 | feeling hot |
fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and...
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fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.
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| 68 | 2021-02-18 | inability to speak, migraine |
Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-find...
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Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-finding difficulty lasting at least a few days. No prior history of migraines. TIA work up ongoing.
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| 68 | 2021-02-19 | pain in extremity |
2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and i...
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2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and it is at times unbearable. My knees don't want to bend. I can't take an anti-inflammatory because I'm on a blood thinner. So far just taking Tramadol and Tylenol Arthritis. Doesn't touch the pain. Still working with doctor to figure out what to do next.
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| 68 | 2021-02-21 | numbness, facial paralysis |
Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable t...
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Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.
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| 68 | 2021-02-21 | pain in extremity, numbness |
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo...
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Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
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| 68 | 2021-02-21 | burning sensation |
Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By M...
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Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By Monday left eye swollen shut. Saw opthmologist prescribed Acyclovir. Over a couple days swelling dissapeared and burning, itching subsided. The thing is, I had my second COVID dose on 02/10/2021, 10:00AM Pitzer Lot #9581. On 02/18/2021 late evening, started to feel burning in left eye nose area again, next morning eye swollen shut. Saw Dr, said I was having an allergic reaction and put me on prednesone and Amoxicylin. No reduction of swelling and burning, blisters were forming. Went to Urgent Care on 2/20/2021 and was prescribed Acyclovir again. Swelling now gone and itching burning diminished.
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| 68 | 2021-02-22 | weakness | Dizziness, weakness, sweating, confusion,stumbling when trying to walk. |
| 68 | 2021-02-23 | weakness | Diarrhea for two days and some weakness from the diarrhea |
| 68 | 2021-02-23 | numbness |
Sudden Onset of Chest tightness and numbness in left arm. History of AFIB and Diabetes. PT Denies ...
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Sudden Onset of Chest tightness and numbness in left arm. History of AFIB and Diabetes. PT Denies SOB, Nausea, or Vomiting. Pt given 324 mg ASA prior to medic arrival. M48/L48 responded and evaluated patient including cardiac monitoring. Pt refused treatment or tx.
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| 68 | 2021-02-23 | weakness |
Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and we...
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Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and weakness Give prednisone and benydrl in IV and took 1 50mg prednisone at home. Weakness for 3 days and swelling has gone down
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| 68 | 2021-02-24 | burning sensation |
*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, unde...
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*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, under my armpit area. I also noticed small, red blotches. *By Sunday, February 21, 2021, there were more blotches that had spread across to my back and across my chest on the left side. There was severe burning, zinging pain that traveled across my chest, under my left arm, and across to my back. * Monday, February 22, 2021, I visited the Doctor who confirmed it was shingles. She prescribed 1 gram of Valacyclovir (Valtrex) 3x daily for 7 days. *The shingles have now covered my entire left breast, under my entire left arm area with a huge patch on my back. It has become extremely uncomfortable with much burning, stinging, and zinging that travels along the rash area and down my left arm.
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| 68 | 2021-02-24 | flushing |
Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10...
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Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM. She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink. She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink. EMT arrived to bathroom and sat patient down in a wheelchair. I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well. EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's. BP 114/61, 96% on RA. Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney. Cool compresses were placed on her forehead and behind her neck. Medics arrived to scene to assess the patient. She stated she was feeling improved and did not want to go to the ED. She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved. She denied dizziness, lightheadedness, nausea or abdominal pain. I assisted her to the bathroom and she had one more episode of diarrhea. She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home. She was able to get up off the gurney without assistance, stated she felt well. She was ambulatory with a Steady gait and assisted outside. Prior to discharge I recommended she follow up with her PCP. Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms. Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
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| 68 | 2021-02-24 | numbness |
Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, follow...
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Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, followed by mild itching, swelling and redness of lips and perimeter of eyes, spike in blood pressure and dizziness, alleviated with paramedic?s IM inflection of 50 mg benedryl and a steroid pill at ER
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| 68 | 2021-02-25 | feeling hot |
15 mins after injection, head, face, neck and chest turned bright RED. Felt hot. Alerted staff . I...
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15 mins after injection, head, face, neck and chest turned bright RED. Felt hot. Alerted staff . I took 25mg ODT Benadryl. Observed by staff for 15 mins more. Skin returned to normal color. NO Swelling, No Breathing problems. Went home , no additional problems.(Slightly sore at injection site, expected).
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| 68 | 2021-02-25 | pain in extremity | Sore arm, low grade fever, chills, headache |
| 68 | 2021-02-25 | pain in extremity |
Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore a...
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Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore arm. Fever treated with tylenol Wed 2/24/2021: No fever in morning, but headache, body ache, mild fatigue all day, sore arm, then fever of 102 in evening (about 5 pm). Treated with Tylenol successfully, fever abated pretty quickly. Thursday 2/25/2021: No fever or headache, but arm still pretty sore without tylenol. Friday 2/26/2021: feeling fine, arm is very slightly sore.
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| 68 | 2021-02-25 | weakness |
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w...
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high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
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| 68 | 2021-02-25 | facial pain |
lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up in...
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lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up into the face; pain goes around into jaw, up into the face; ear hurts; felt dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 23Jan2021 at a single dose for covid-19 immunization. Medical history included high blood pressure (Diagnosed 3 to 4 years ago) and thyroid disorder. There were no concomitant medications. It was reported that the patient got the vaccine on Saturday and went home and fell asleep, woke up and had lumps in back of neck, they hurt, pain goes around into jaw, up into the face and ear hurts. The patient just tried a hot compress, a hot cloth on there, it seemed to help a little bit for a while. Took some Advil and that helped a little bit, but when it wears off it comes back. Adds she felt dizzy too, and still felt like that too, it started right after she got it, and it comes and goes. The outcome of the event dizzy was unknown while not recovered for the remaining events. Information about lot/batch number has been requested.
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| 68 | 2021-02-26 | feeling hot |
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:...
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11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site, & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days. 02/23/2021 itchinesss better. Brown square area at site of injection. There is still a slight itch at times as if healing.
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| 68 | 2021-02-26 | flushing | FLUSHING AND DIZZINESS THAT IMPROVED WITH A FAN. FLUSHING WAS FIRST BUT NOT AS SEVER. |
| 68 | 2021-02-26 | pain in extremity |
KNUCKLES SWELLED UP WITHIN 48 HOURS, WHEN DRIVING IT WAS UNCOMFORTABLE TO HANDLE THE STEERING WHEEL....
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KNUCKLES SWELLED UP WITHIN 48 HOURS, WHEN DRIVING IT WAS UNCOMFORTABLE TO HANDLE THE STEERING WHEEL. USED OTC PHARMACY BRAND MENTHOL BASED ROLL ON TO DEADEN THE PAIN. NOT EVER HAVING ARTHRITIS, I BELIEVE THIS DISCOMFORT WOULD BE SIMILAR AS MY KNUCKLES WERE THROBBING. PLEASE NOTE, THAT THIS SWELLING IS NOW SUBSIDING, DID NOT AFFECT ANY OTHER JOINTS.
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| 68 | 2021-02-26 | inability to speak, seizure like phenomena |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
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| 68 | 2021-02-26 | pain in extremity |
Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, ...
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Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, a large rash with white bumps on chest area by shoulder. Additionally, a large brown spot on opposite shoulder from injection. Very sore arm for 3 days unable to lift it .
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| 68 | 2021-02-27 | tremor | Fever 99.9 and shaking, after that 102.7 fever and tiredness. |
| 68 | 2021-02-27 | numbness and pain in extremities |
In one hour, extremely dry month, tongue and throat. Sharp pain on left side of forehead that would ...
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In one hour, extremely dry month, tongue and throat. Sharp pain on left side of forehead that would come and go. Overall, not feeling well. A few hours later (about 4 hours), tingling and numbness (neuropathy) in my lower legs and arms. Some neuropathy on left side of face.
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| 68 | 2021-02-27 | night sweats |
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ...
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Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
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| 68 | 2021-02-27 | pain in extremity |
Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until a...
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Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until about 3:30 and I started to get chills, body aches and pains then nausea and headache. Shivering for 4-5 hours under the covers in bed with extra blankets and clothes. Can?t say I?m overly concerned as searching online I?ve seen reports of similar reactions but best to report. Today feeling a bit better, not shivering but still achy but not as bad and still a little nauseous.
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| 68 | 2021-02-27 | tremor | chills, shakiness, shortness of breath, body aches |
| 68 | 2021-02-28 | weakness |
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injecti...
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Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injection was on Friday and Saturday we woke up with the side effects. Sunday we were much better and Monday better.
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| 68 | 2021-02-28 | weakness | Palpitations, weakness-cleared by EMS |
| 68 | 2021-02-28 | pain in extremity |
pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under...
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pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under right arm (site of 2010 lumpectomy, with sentinal lymph node removed, so less swelling). swelling and achiness reduced but still present 1 week later.
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| 68 | 2021-02-28 | tingling |
the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area...
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the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right upper arm on 25Jan2021 at 11:30 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included Influenza vaccine in Dec2020 and Balance of Nature Fruits as supplement since Jan2021 - she started taking Whole Foods brand Balance of Nature Fruits pills and has been taking them off and on for the last couple weeks. On 27Jan2021, the patient had a lumpy, red area on the opposite shoulder from where she received the COVID-19 vaccine. She said she discovered the lumpy, red raised up bumps area on her left shoulder that morning. She said the lumpy, red area is on the back of her left shoulder, neck and hairline area. She said her husband said the lumpy, red area is a couple square inches in size. She said the lumpy, red area is not itchy, but it is tingling, and stings sometimes. She also asked if what she is experiencing is a side effect of the vaccine. The patient declined any treatment for the events saying she didn't know what to do. The event "lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder" had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.
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| 68 | 2021-03-01 | pain in extremity |
More of an administration error.. It was given by a distracted national guardsman who was waving a...
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More of an administration error.. It was given by a distracted national guardsman who was waving around syringe and talking to someone else as he grabbed my arm---I saw him expel a sizable amt of vaccine from the TB syringe before administering (I'm a retired NP) so was concerned that I had gotten a suboptimal dose---really have no idea how much I got and didnt point out his error b/c I was pretty sure they wouldnt draw up another dose for me . Anyway--just reporting this b/c I was asked to and am hoping for the best! I did have a sore arm, muscle aches and chills so I know that I got some.
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| 68 | 2021-03-01 | pain in extremity | Pain in Left, swelling, Lump at injection, Area is Hot |
| 68 | 2021-03-01 | tingling | Tingling in face No swelling or shortness of breath |
| 68 | 2021-03-02 | numbness, tingling |
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face...
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3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
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| 68 | 2021-03-02 | flushing |
About an hour after I received the vaccine my entire head was in pain including upper jaw and back o...
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About an hour after I received the vaccine my entire head was in pain including upper jaw and back of neck. My face was flushed and my throat began to tighten a little The headache and flush lasted about an hour. (I had taken Tylenol right after getting the vaccine.) The throat symptoms lasted longer ,lessening slightly after about an hour and a half. Never had trouble breathing, talking, eating or drinking. But the feeling has lasted into the late evening to a very mild degree; as if something is caught at the back of the throat, or the back of the tongue feels a little fuzzy.
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| 68 | 2021-03-02 | pain in extremity, numbness |
About two hours after receiving the Pfizer vaccine shot #1, my left arm became numb and stiff, start...
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About two hours after receiving the Pfizer vaccine shot #1, my left arm became numb and stiff, starting at my wrist and worked up my upper arm. I could not lift my left arm at all, but when I tried, the pain was severe and radiated over the left half of my chest and over my heart. I thought this might be a passing reaction, and went to bed early. My condition was the same in the morning, and I contacted my doctor, who directed me to go to the emergency room or to Urgent Care, which I did.
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| 68 | 2021-03-02 | discomfort, weakness |
Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where ...
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Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where I have issues now and then). It is bothersome to the point that I cannot find a comfortable position to relieve the pain. It feels like my lower body is being seized up, so to speak. The only way I can sleep is to take 2 Aleeve PM tablets. I take regular Aleeve throughout the day to take the edge off the pain. The reason I suspect it is a side effect is that a year ago I took the new Shingles 2-dose vaccination. I had this same reaction after taking the first dose - and it occurred about 2 weeks after that shot.
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| 68 | 2021-03-02 | nerve pain |
Sore left arm near site the first 72 hours which I expected . Since then it feels like nerve pain ex...
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Sore left arm near site the first 72 hours which I expected . Since then it feels like nerve pain extend above and below the site.
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| 68 | 2021-03-02 | weakness, cold sweat |
she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it...
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she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it was going to fall off it hurt so bad; she has ran a temperature and that finally broke but the highest was 102.4; She has been so weak she hasn't been out of bed hardly.; tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9265), via an unspecified route of administration from 29Jan2021 14:45 (2:45 PM) at single dose on right arm (as she was left handed) for COVID-19 immunization. Medical history included COVID (recovered) on an unspecified date. There were no concomitant medications. No additional vaccines administered on same date of Pfizer suspect. Patient previously got her flu and shingles shot at the end of "October". Patient took the vaccine last Friday (29Jan2021) at the age of 68 years old (reported as "68 and a half"). She does not know if that makes a "different" but her right arm felt like it was going to fall off it hurt so bad, on a scale of 1-10 it was about a 20. It was really tender she put a heating pad on it, she has been sleeping on the heating pad and it was mild now. It was only about a 3 now and it has come down, but it hurt like the dickens. Also she has ran a temperature and that finally broke but the highest was 102.4. Patient has slept around the clock and she has not been out of bed but like 30 minutes out of the last 24 hours (hrs) just to go the potty or drink something. Patient stated "almost gave up holding it was so long". She has been so weak she has not been out of bed hardly. Patient said that she has eaten since, "lets see Saturday night, Sunday, Monday". Patient has not eaten since Saturday night (30Jan2021) or gotten out of bed. She has not eaten anything. Patient has had COVID and recovered so she did not want to catch that again. She confirmed that she had COVID prior to received the vaccine. She called her primary care and she has a viral phone call tomorrow or visual phone call, whatever its called, she was trying to get over this mess, she feels warm, she was not registering a temperature right now but she had a cold sweat or something right now (01Feb2021). Patient has a call with him tomorrow so he will know about this incase Pfizer calls. Patient stated that she knows with a normal vaccine she might have an ache or something but this one hurt bad, maybe they pushed it in too hard or something she does not know. When asked for vaccination facility type, the patient answered that they had a vaccine clinic they had set up there in a conference room, they had an elaborate set up, go through certain places and there were several steps. Vaccine was not administered at facility (reported as "No hospital"). Patient further reported that her arm on 29Jan2021 (Friday evening) was tender. Patient lives by herself, she came home and does not know if she event ate. All she knows was she was real tired that Friday evening, it was tender and it got worse. Events did not require emergency room and physician room visit, reported as "Not to date but tomorrow she does not know if he will have her come in unless she spikes another fever or if he will do anything she may just ride it out". When asked for adverse events prior vaccinations, the patient answered "no none that she can remember. Sometimes she will have a sore arm that is why she gets it in the right arm because she is left handed thinkin her dominant hand will not have any problems but this one hurt really bad. Have they had many calls where this is really effecting arms really bad?". Patient also reported that her sister had the shot the same day and her arm was a little sore but that was all, she does not have NDC lot expiration for her sisters dose of the vaccine. She went to a different facility in a different location. Outcome of "her right arm felt like it was going to fall off it hurt so bad" was recovering, while for other events was unknown.
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| 68 | 2021-03-02 | numbness, tingling | tingling on left side of face. Evaluated by EMS-Cleared |
| 68 | 2021-03-03 | bell's palsy |
Bell Palsy; This is a spontaneous report from a contactable consumer (patient) reported that a 68-ye...
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Bell Palsy; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on the left arm on 17Feb2021 11:30 at a single dose for covid-19 immunization. The vaccine was administered at the hospital. Medical history included blood pressure, cholesterol, and gastrooesophageal reflux disease (GERD); all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medications included benazepril, oxybutynin hydrochloride (OXYBUTININ ACCORD), ezetimibe, fenofibric acid, and esomeprazole; all were taken from an unspecified date for an unspecified indication. The patient experienced facial numbness then the patient went to the ER and was diagnosed with Bell's palsy on 17Feb2021 16:00. The patient underwent lab tests and procedures which included computerised tomogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of bell palsy. The outcome of the event was not recovered.
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| 68 | 2021-03-03 | pain in extremity |
Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with...
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Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21. Afterwards, she had a sore arm and slept most of the next day. On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom. She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination. Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy. She continues study medication without any missed doses. She will most likely be in Rehab for another week. She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE. As of 3/4/2021 the patient is still in rehab.
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| 68 | 2021-03-03 | pain in extremity |
chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient)....
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chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration on left arm on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient got her second shot of COVID vaccine yesterday, 01Feb2021, and was asking if she was infectious to anyone. She had some chills, was very fatigued and was a having sore arm. The sore arm started last night (01Feb2021) and when she woke up this morning (02Feb2021), she was with the chills and fatigue. The patient stated that they could be related to the fact that she got up at about 3:00 in the morning. The outcome of the events was not recovered.
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| 68 | 2021-03-04 | difficulty speaking, flushing |
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient w...
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30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient was coughing and clearing throat. Fluids were offered and patient was moved to a more private area, vitals were taken. Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm. Rapid response team was notified and took the patient to the hospital's emergency department.
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| 68 | 2021-03-04 | difficulty speaking, weakness |
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint ...
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6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness. Attempted to sleep after taking Advil with nightmares and restlessness. Felt this overall feeling of crying and uncontrolled sobbing. I had COVID in May of 2020 with hospitalization, Remdesivir IV. Pneumonia . July I was feeling better with noted Shortness of Breath not brought on by activity. I was able to resume my exercise activity. I walked but no longer able to walk 3-4 miles per day. I am walking 2 miles w strengthening exercise. The headache comes and goes with the addition of Advil and Tylenol alternating takes the edge off. I take a Zyrtec but it does not help
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| 68 | 2021-03-04 | weakness |
Dizziness and weakness started the morning after vaccination, and gone by that late afternoon Treate...
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Dizziness and weakness started the morning after vaccination, and gone by that late afternoon Treated with not moving and laying down
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| 68 | 2021-03-04 | tingling |
Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird...
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Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation; This is a spontaneous report from two contactable consumers (patient's cousin and patient herself). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration in right arm on 10Feb2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included anxiety. It was reported that the patient was "physically fit. She was thin and was about 5 feet." Ongoing concomitant medications included escitalopram (reported as "generic Lexapro") for anxiety, calcium, and multivitamins. The patient previously received flu vaccine in Oct2020. She also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via an unspecified route of administration in left arm on 20Jan2021 10:30 AM for COVID-19 immunization and felt a little soreness in arm and light headache the same day. Two nights later, her scalp felt on fire and had tingling sensation in her face for three weeks. A week after the first dose, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put her on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation and noticed some spikes in her blood pressure. Her physician told her to take another 2.5 mg amlodipine if needed. After her second dose, she went to sleep with achy arm. she woke up that night with a tingling sensation from head to toe. Her whole body was tingling. It was a weird and scary on and off sensation. She stated it had improved during the past two days. The patient confirmed that she had no heart rate problems. She actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. She mentioned her 97-year-old mother and husband both got the two doses with no complication or reactions. The patient's cousin was "pretty sure that it's Guillain-Barre." The patient stated the Guillain-Barre syndrome has not yet been confirmed. She had an appointment with a neurologist. The outcome of 'tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation' was recovering, of remaining events was unknown.
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| 68 | 2021-03-04 | numbness | Numbness in lips and face on left side, same side as injection |
| 68 | 2021-03-04 | pain in extremity |
Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 A...
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Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 AM on 3/2 and slept for 3 hours. All expect the inflamed elbow were not a surprise. I treated my elbow with an ice pack during the day on 3/2 and by 3/4 it had improved. By 3/5 it was no longer inflamed, red or warm, but is still tender to lean on. I informed my doctor's office of this.
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| 68 | 2021-03-04 | tingling |
Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, le...
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Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, left hand tingling resolved. PO Benadryl 25 mg given. BP 147/80 (pulse 80), then 151/82 (pulse 78).
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| 68 | 2021-03-04 | cold sweat |
Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseo...
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Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.
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| 68 | 2021-03-04 | pain in extremity |
pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the ...
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pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the covid vax. She started having vision problems about an hour after receiving the vaccination. She stated that her vision is blurry and she has to blink a lot so she can see anything. Today 3/5/2021 the only symptom she is having blurred vision. Pt will contact her PCP if her symptoms persist.
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| 68 | 2021-03-04 | tingling, pain in extremity |
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres...
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week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
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| 68 | 2021-03-05 | nerve pain, pain in extremity |
About 12 hours after 3/4 vaccine, began to experience intense flare-up of neuropathic pain in droppe...
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About 12 hours after 3/4 vaccine, began to experience intense flare-up of neuropathic pain in dropped R foot, especially around large R toe. Went to bed. Woke up in pain around 3 am on 3/5. Drank water. Applied Castor oil and Arnica. No sound sleep rest of night. On rising, showered. Heat helped a bit. Drank more water. Applied more Castor oil and Arnica. Pulsing electrical/spasm-like pain continued in R foot, especially between big toe and 2nd toe. Though felt vaguely nauseous, ate and stayed hydrated. Could not work. Laying down and warming, elevating foot helped. Around 9 pm on 3/5, intense flare-up began to subside.
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| 68 | 2021-03-05 | tingling, pain in extremity |
As expected, my left arm was very sore the day following the vaccination. However, since then, my ar...
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As expected, my left arm was very sore the day following the vaccination. However, since then, my arm has gotten very painful, especially from the shoulder to the elbow. I cannot raise the arm,have limited range of motion, sometimes tingling, needles and pins. For about 10 days, the underarm, the armpit, turned red, black and blue and bruised looking. This has begun to subside. But the pain continues to increase. I have seen my personal physician twice and have had a shoulder X-ray,a neurological exam of the arm, also a vascular ultrasound. I am still waiting for an appointment with an orthopedic specialist.
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| 68 | 2021-03-05 | pain in extremity |
The injection site appears to be too high on my left shoulder and not properly placed in the deltoid...
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The injection site appears to be too high on my left shoulder and not properly placed in the deltoid muscle. I developed severe left shoulder joint pain by the afternoon March 5. By bedtime, the pain was excruciating and continues to be severe, not in my arm, but in my left shoulder joint. I had adhesive capsulitis several years ago and completely recovered, but it took two years to get back my health plus a steroid injection and physical therapy. I know what adhesive capsulitis feels like. And this is what my left shoulder socket feels like now. I had no idea this was a risk of a vaccination. I have sent an email to report this injury to UCSF and also requested an appointment with my doctor. This type of injury from vaccination should be avoided and is avoidable.
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| 68 | 2021-03-06 | tremor | Severe shaking, muscle aches, chills |
| 68 | 2021-03-07 | pain in extremity | Joint pain in knees, shoulders and hands. Three weeks thus far. |
| 68 | 2021-03-07 | tingling, weakness |
Pt received 1st dose of Pfizer Covid vaccine 3/5/2021 at the Health Dept at approx 9:35AM; pfizer lo...
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Pt received 1st dose of Pfizer Covid vaccine 3/5/2021 at the Health Dept at approx 9:35AM; pfizer lot number EL9269. Patient has hx of widespread rash from Penicillin; no history of anaphylaxis. Pt alerted the medic at 10:05AM that she was experiencing nausea and body weakness. No other symptoms noted at that time. BP 138/76 P84 O2RA 98%. At 10:35AM pt experiencing worsening nausea, body weakness, generalized prickle sensation, sudden left-sided headache, & dry heaving. Epi 0.3mg auto injector(Lot 0FM534) administered right leg 10:40AM; BP 178/104 P90. Paramedics called 10:42, arrived at 10:46AM and assumed care of patient. Patient transported to Hospital.
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| 68 | 2021-03-07 | tenderness |
SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT ...
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SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT MUCH. UPON WAKING DAY TWO, I HAD A VERY PRONOUNCED ACHE IN THE BACK OF LEFT SHOULDER AND THE ACTUAL SHOULDER BLADE WAS SORE AND PAINFUL TO THE TOUCH. I DID NOTHING THE FIRST DAY OF THE DISCOMFORT (THINKING IT WOULD GO AWAY). I NOW APPLY CBD/THC BALM ON THE AREA 3 TIMES A DAY AND I'VE BEEN TAKING EXTRA STRENGTH TYLENOL , TWO TABLETS, THREE TIMES A DAY. I AM SLEEPING IN A ZERO-GRAVITY MODE ON MY SLEEP NUMBER BED...OTHERWISE I CAN'T SLEEP AT ALL. I HAD A HOLE IN MY ROTATOR CUFF SURGUCIALLY REPAIRED ABOUT 18 MONTHS AGO AND THE PAIN I HAVE NOW ACTUALLY FEELS LIKE MY SHOULDER FELT BEFORE AND FOR AWHILE AFTER THE SURGERY! I AM BEGINNING TO WONDER IF THERE IS A RELATIONSHIP TO THE TWO EVENTS.
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| 68 | 2021-03-07 | feeling cold |
Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, ...
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Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, EXTREME lethargy, initial chills and later on sweats, cold sensation at the roof of my mouth, and within 6 hours a sore arm at the injection cite. I ended up sleeping off and on for the next 29 hours. The headache, the lethargy and sore arm persisted past 24 hours. The headache was gone after about 28 hours. The sore arm was gone by the morning of the 2nd day (Monday). The lethargy lasted for 36 hours but was completely gone by the morning of the 2nd day (Monday).
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| 68 | 2021-03-07 | pain in extremity |
Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to proces...
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Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to process thoughts logically. Arm somewhat sore, but not horrible. This lasted until I went to bed Friday night at 11:00 PM
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| 68 | 2021-03-07 | feeling cold |
Woke up at 3 so cold, I rolled my shoulders in to keep warm. So my chest is really hurting. I took...
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Woke up at 3 so cold, I rolled my shoulders in to keep warm. So my chest is really hurting. I took my temp and it was 100. I was so cold I thought it was 102. I drank water and took nyquil. I was able to sleep better. I still have a fever of 100, however not feeling as bad. However my chest is very tight.
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| 68 | 2021-03-08 | feeling hot |
Pt began feeling warm from head to toe, and dizzy. All vitals were stable and within 20min client st...
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Pt began feeling warm from head to toe, and dizzy. All vitals were stable and within 20min client stated that she was feeling normal again.
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| 68 | 2021-03-09 | pain in extremity |
11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (...
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11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (not the injection site, the whole upper arm muscle). Three weeks after the shot, my arm is still very sore and I can hardly use my left arm. It's very painful to get dressed, take off a jacket, shirt, etc. I can hardly use the left arm to hold anything due to the pain in the muscle.
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| 68 | 2021-03-09 | muscle twitching |
2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched s...
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2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched several times approx. 6-7pm,Light headache approx. 8pm Anxiety increased between 8pm-2am,Woke 3:49 am with bad headache in rear of head, went to bathroom and turned over. Woke up with bad headache a little while later, Several times woke up struggling to swallow. Last time I woke up with Difficulty breathing and pressure on chest Decided I needed to wake my husband, but that is my last thought or action until I woke up 9AM. I take a generic Zyrtec at supper time each night. I think had I not had Zyrtec these symptoms could have been serious. Was OK until 3 11pm 3/9/2021 Slight headache & Shortness of breath.
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| 68 | 2021-03-09 | pain in extremity |
Continuing pain in left arm from date of vaccination on 2/24/2021. No other side effects like fever...
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Continuing pain in left arm from date of vaccination on 2/24/2021. No other side effects like fever. Took ibuprofen and used a heating pad. Went to PCP today and have prescription for MOBIC to help with discomfort and suggested icing and movement of affected arm. Will get next vaccine shot 03/20/2021 at 8:20 am in right arm and hope that I don't the same side effect in that arm. Is it possible to get the injection in a different muscle site?
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| 68 | 2021-03-09 | pain in extremity |
Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of p...
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Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination. No follow-up attempts are needed. No further information is expected.
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| 68 | 2021-03-10 | night sweats |
late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick ...
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late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick yellow bile. felt nausiated all day, "foggy" headache and lack of appetite. night sweats for 2 nights. no fever.
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| 68 | 2021-03-11 | migraine |
3 hrs after 1st vaccine developed bad headache, lasted about 36 hrs and then completely resolved. 1...
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3 hrs after 1st vaccine developed bad headache, lasted about 36 hrs and then completely resolved. 12 hrs after 2nd vaccine, same headache last about 24 hrs then completely resolved Feb 28 same headache suddenly redeveloped and have been chronic since that time along with new dx of HTN. Seen by doctor 2 times and ER that did CT of head/EKG/labs all normal so final discharge dx was migraines with HTN. I have never had headaches or HTN in my past medical history. Rx Lisinopril 10mg and Medrol 6 day dose pack have done little to relieve these symtoms.
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| 68 | 2021-03-11 | tingling | Bilateral tingling in legs, cleared by medics. |
| 68 | 2021-03-11 | feeling hot |
Client received the first dose of her Pfizer COVID-19 vaccine and during the post-vaccination wait p...
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Client received the first dose of her Pfizer COVID-19 vaccine and during the post-vaccination wait period, she complained of feeling warm, palpitations and tightness in the chest. ?911? was immediately called. She denied any itching or difficulty breathing and stated that she has a history of allergies as well as hypertension, for which she takes Lisinopril, 30mg and Lasix, 40mg. She also indicated that prior to coming in for the vaccine, she took some steroids and antihistamines at the suggestion of her primary care physician. Vital signs were as follows: BP=174/100, Pulse=111. A recheck of her BP was 200/110. The EMT ? responded to the call. They evaluated the client, treated her with an EpiPen and started an IV line. At 11:15, she was transported to the hospital.
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| 68 | 2021-03-11 | tingling |
Complaint of "prickly" sensation after vaccine at site in L deltoid, down to full five fingers. Not...
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Complaint of "prickly" sensation after vaccine at site in L deltoid, down to full five fingers. Noted a bit of sciatic; has historically, not upon arrival. No apparent rash, itching, no shortness of breath; throat a bit dry. BP 142/80; pulse 62; p ox 98; fairly normal vitals for her. As sat and monitored, increased BP to 162/90. After 10-15 minutes, arm better; BP 148/76. Felt stable; wanting to leave as going to MD with husband. After walking in hall, felt "sharp pain in coccyx", lost balance and leaned on wall. BP 150/90. At this point, decided to be evaluated by ED; rapid response and transported by wheelchair.
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| 68 | 2021-03-11 | pain in extremity |
Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up ...
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Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up with vertigo. All symptoms went away within the next 24 hours.
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| 68 | 2021-03-11 | flushing | Swelling tongue, flushed face |
| 68 | 2021-03-12 | weakness, flushing |
Fushing of face by 4:15pm Slight headache by 5:30 No fever Slept from 7pm to 6:00am the next day. 3/...
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Fushing of face by 4:15pm Slight headache by 5:30 No fever Slept from 7pm to 6:00am the next day. 3/12/21 Headache intensified around 10am Slept on and off all day No fever During the night had a few chills 3/13/21 Headache has lessened Body is weak
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| 68 | 2021-03-12 | cold sweat, feeling cold, tremor |
Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused...
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Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused room spinning and broke out in cold sweat. Severe vertigo continued through second day (Feb 22), but seemed to diminish somewhat toward evening. Day 3 still had moderate vertigo/nausea but better than previous day. Went on a long walk. Day 4 moderate vertigo/nausea continued. Tried doing Epley exercises for vertigo. Vertigo/nausea became severe again, so severe I vomited several times. After vomiting got the shakes and felt very cold. Checked blood pressure and it was very high (170/98), but pulse rate was in low 30s. After a few hours blood pressure and pulse rate became closer to normal. Almost decided to go to ER clinic, but decided to wait until my daughter came home from work because I was way too dizzy to drive. After I calmed down I decided it wasn't an emergency. Severe vertigo continued through evening of day 4. On day 4 I called primary care doctor to see if there was anything I could do for the vertigo. She prescribed meclizine, but hearing that it is an antihistamine, I declined it (antihistamines make my heart race and make me very anxious). Severe vertigo/nausea continued through day 5 and day 6. (Severe vertigo/nausea being that I could not move around at all other than to sit still staring forward without the room spinning.) All this period I also had a headache, a feeling of pressure through my whole head/sinus area, and my vision was blurred. I also felt as though I could not focus my eyes or concentration. I tried using some over-the-counter nasal decongestant spray for 2 days to relieve congestion in head, but they made me feel very anxious, so I stopped. I also tried taking some Aleve a couple of times. It helped a little, but made me feel woozy, so stopped. Day 6 the vertigo/nausea improved to moderate, but I could still not walk straight. I felt unsafe to drive. Day 7 continued to improve, but still moderate vertigo/nausea. Day 8 I noticed a lot of improvement in vertigo/nausea. Kept improving day 9. By evening on day 10 I was noticing a rawness and lump in the back of my throat. Called primary care office day 11 to see someone. Drove car, but felt marginally safe driving. Was diagnosed with a sinus infection and prescribed a 10 day course of Amoxicillin/Clavulanic Acid (875-125 mg for 2 pills a day for 10 days). Felt improvement in throat and sinus over next few days. Day 15 I felt greatly improved with head ?fog? and vertigo. Had an appointment with an ENT clinic on day 15 to see what was causing vertigo. All tests were good for hearing, and visual examination of ears. Was checked for BPV but that was ruled out. Said vertigo was probably caused by viral infection or inflammation of vestibular nerve or canals. Recommended waiting for improvement and coming back if it persisted. Began doing more normal activities even though I still had mild vertigo. Day 16 felt still better in morning, then in afternoon bent over quickly to catch something and got a terrible wave of spinning again. Moderate/severe vertigo continued that evening. Improved to moderate on day 17 and 18. All along, when vertigo was worse, so was the ?fog? (blurry vision, inability to focus mentally). At day 19 I feel like I did on day 15, but I have noticed the pressure/lump around my ear and on left side of head is improved. Brain ?fog? is improved too, very mild and the vertigo is mild. I finish my antibiotic tomorrow.At present vertigo is not gone. Its mild today, but this is only one of maybe 2 1/2 days in which its been this mild (out of almost three weeks since I was vaccinated). I have been drinking a lot of water every day, and ginger tea when I get nauseous. I had my 2nd dose of the COVID Pfizer vaccine scheduled for Mar 15. I?ve cancelled it and intend to wait to see how long it takes for vertigo to finally resolve before considering a 2nd dose.
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| 68 | 2021-03-12 | discomfort |
I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed wh...
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I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed what I would describe as discomfort in the lymph system. Also, I have difficulty thinking clearly. Tasks that I usually complete easily such as online banking have been more difficult. I'm making mistakes. As I write this I am now three days from the inoculation. I have burning pain under my right arm. I have burning pain in tops of my feet. My hip joints are stiff. My eyes are sore. I feel generally fatigued. This is not my normal level of functioning.
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| 68 | 2021-03-12 | pain in extremity |
Started with very sore arm evening of shot. Next day - queasy stomach, headache, all over achiness,...
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Started with very sore arm evening of shot. Next day - queasy stomach, headache, all over achiness, continued sore arm but better than prior pm. Arm still a little sore following day but all other symptoms gone.
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| 68 | 2021-03-13 | weakness |
Headache - AM 3/9/21 - took Tylenol, which helped to reduce it. Headache went away completely later ...
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Headache - AM 3/9/21 - took Tylenol, which helped to reduce it. Headache went away completely later in the day Fatigue - not severe but I wasn't as energetic as usual. Lasted until next morning (3/10/21)
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| 68 | 2021-03-13 | weakness | weakness, slow breathing. Evaluated by EMS-Refusal to transport. |
| 68 | 2021-03-14 | pain in extremity | Severe arm pain followed the next day by severe mid- and lower back pain |
| 68 | 2021-03-14 | weakness |
While reading in the waiting room I realized that I was scratching my hand vigorously because it itc...
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While reading in the waiting room I realized that I was scratching my hand vigorously because it itched so much. The underside of my arm looked redder, like it had a fine rash. I felt too weak to get up and walk to the desk (15 feet) where I was supposed to report such things. A worker was disinfecting chairs and came near, so I asked for his help. He let me hold his arm and took me back to the nurses. My pulse was slightly lower than my normal resting pulse rate, but blood pressure ok. They wheeled me to Urgent Care. My head was itching and I did not feel that I could stand up with any confidence. Eventually they gave me a shot of Benadryl (25 mg) and an oral medicine to soak up histimines in my stomach. I went home, where at around 4 PM I began to feel more normal. I took Benadryl the next day when I started itching again.
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| 68 | 2021-03-15 | burning sensation |
Burning in left arm then swelling. Immediately after. Then a few hives, then slight tongue swelling ...
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Burning in left arm then swelling. Immediately after. Then a few hives, then slight tongue swelling within 1.5 hours.
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| 68 | 2021-03-15 | tenderness |
Facial, neck and upper arm swelling. Most profound swelling of lip and nose. Tenderness upper arm ...
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Facial, neck and upper arm swelling. Most profound swelling of lip and nose. Tenderness upper arm and neck. Applied ice. Took Benadryl
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| 68 | 2021-03-15 | pain in extremity | Headache, sore arm, joint aches |
| 68 | 2021-03-15 | feeling cold |
I had chills. I was very cold and shivered continuously for about 30 minutes. After the shivering ...
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I had chills. I was very cold and shivered continuously for about 30 minutes. After the shivering stopped, I went to sleep and slept normally. I had no lingering adverse effects and did not see a doctor related to this event.
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| 68 | 2021-03-15 | numbness |
I received Covid 19 shot #1. Approximately 10 min later I felt numbness in my wrist that traveled up...
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I received Covid 19 shot #1. Approximately 10 min later I felt numbness in my wrist that traveled up my arm. I notify the workers administrating the vaccine about my issues. They requested I follow them to the back of the auditorium. I sat down with a male ?medic? present then, another male worker who identified himself as an LVN nurse who said he was the nurse in charge arrived and both attended to me by taking my vitals. After some time, they said my vitals were okay. I started to feel better although my numbness was still there but to a much lesser degree, I was allowed to leave,
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| 68 | 2021-03-15 | pain in extremity |
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on m...
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Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events. No follow-up attempts needed. No further information expected.
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| 68 | 2021-03-15 | weakness, tremor, feeling of body temperature change |
Lightheaded and weak 11 am March 15th fever of 100.2 with Tylenol all day shaking chills with hot an...
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Lightheaded and weak 11 am March 15th fever of 100.2 with Tylenol all day shaking chills with hot and cold spells, rattling chills so I could not even text with my fingers, extremities cyanotic, but that is usual for me when I am very cold. Got into a very hot tub of water and stayed until my core warmed up. Spell lasted about 2 hours and then resolved. Felt much improved on 3/16/21
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| 68 | 2021-03-15 | pain in extremity |
The injection was given to me as if I was a dartboard . The pain I had when I got home was so bad, a...
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The injection was given to me as if I was a dartboard . The pain I had when I got home was so bad, and ran across back of my neck to other shoulder. I feel she injected to high up and close to shoulder ...and pain went down my left arm to hand ...also pain was radiating up back of neck... this was very concerning to me... 2-3 days with this symptom
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| 68 | 2021-03-15 | pain in extremity |
chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard an...
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chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard and could feel below the esophagus area, March 12 at 6:30 am T 99.9, BP 151/85 achy , took tylenol and at 8:40 am BP 128/ 74 P 93, my back ached all day, 3:45 pm BP 141/74 P 90, Took tylenol for achy body, 6:00pm BP 158/82 P 84, 8:08pm BP 138/73 P82 . Felt very tired and slept in my chair 3:30- 6:00 pm, felt really exhausted and went to bed early : slept 9:00pm-7:00 am . Saturday 3/13 /21 felt better T 97.3 BP124/69 P 64 felt fairly good all day but tired
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| 68 | 2021-03-16 | facial paralysis, bell's palsy |
Got COVID shot March 3, then had some alteration of taste around March 8 or so, then L facial paraly...
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Got COVID shot March 3, then had some alteration of taste around March 8 or so, then L facial paralysis consistent w Bell Palsy on March 11.
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| 68 | 2021-03-16 | muscle spasms |
Muscle spasms in each hand and each foot (fingers or toes locked in place for about 2-3 minutes. Aft...
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Muscle spasms in each hand and each foot (fingers or toes locked in place for about 2-3 minutes. After that, a few days later the left leg became stiff at the hip joint. A wee later the right leg also became stiff at the hip joint snd now my walk gait is limited(snd I am unable to ring as my legs won?t move back and forth enough to allow running). Pain is moderate.
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| 68 | 2021-03-16 | tremor, flushing, tingling, burning sensation |
she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; bu...
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she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
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| 68 | 2021-03-17 | muscle spasms |
#1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve fo...
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#1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve for 2 days, better, #2 3/8/21 - lump under arm, palpitations 3/9/21 lasting 1 1/2 days, left side swelling on back 3/15/21, went across lower back, by 3/17/21 back pain worse and felt like couldn't breathe due to back muscle spasms went to ED, sore but better today 3/18/21
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| 68 | 2021-03-17 | muscle twitching |
A very mild twitch began in my right upper lip that has grown slightly, is now sometimes on the othe...
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A very mild twitch began in my right upper lip that has grown slightly, is now sometimes on the other side and on the area between my nose and lip. It occurred only occasionally at first, but has increased over time. Though not noticeable by others, it is a slight distraction and mildly troubling because of my concern that it may worsen over time. I hope this is not the case, but felt this feedback may prove helpful in some way.
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| 68 | 2021-03-17 | weakness |
Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to...
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Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to sleep (ongoing, 6th day) Swelling of the face, particularly left side more affected (noticed on 6th day after injection) Bad taste in mouth and dryness Eye sockets darkened, more so in the left eye (noticed on the 4th day after injection; ongoing)
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| 68 | 2021-03-17 | feeling hot |
Patient in the observation area post vaccination c/o "hot feeling" tightness in her throat. The pat...
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Patient in the observation area post vaccination c/o "hot feeling" tightness in her throat. The patient admits to having had anaphylaxis reactions in the past to latex, penicillin and clindamycin. Patient states this feeling is similar to what happens when anaphylaxis is pending. Patient was transported to the ER for observation.
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| 68 | 2021-03-17 | numbness |
She received the vaccination, and almost immediately she started getting a numbing feeling on her le...
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She received the vaccination, and almost immediately she started getting a numbing feeling on her left side It started at her face, half her lip and into her jaw, and down her leg on the left side., the upper thigh/leg and the calf, down her feet into her toes. There was just a slight numbness in her chest, she didn't think much of it as she had family members who had no reactions. That subsided a little. The feelings lasted all day Monday, all day Tuesday, got concerned yesterday Wednesday 3/17/21. She called the CDC and they transferred her to a nurse who told her to go see her doctor. She called her doctor and she described her reaction and told her that they did not know if it was stroke-like and they told her to go to the hospital. She went to the hospital yesterday and they did an exam on her and one of the doctors who consulted with his connections with the CDC and decided that they would have to do an MRI on her to make sure it did not cause a stroke. She did have the MRI which they looked at it and told her that it looked clear and was not a stroke, however, she is to FU with a Neurologist and her PCP. The only thing that she was given to try was something for allergies, Benadryl to see if that would help with the reaction. She still has some feelings of numbness in the same areas as listed above.
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| 68 | 2021-03-17 | weakness |
a significant headache this morning with pain focused at the front of her head; Weak feeling; feelin...
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a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
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| 68 | 2021-03-18 | burning sensation, pain in extremity |
At first just a sore arm but on the 13th in the evening noticed burning in my legs which over the ne...
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At first just a sore arm but on the 13th in the evening noticed burning in my legs which over the next few days became severe there and moderate over other areas of the body with skin being very sensitive to clothes rubbing on it. This had happened before with the shingles vaccine given 10/11/2012 which was reported to VAERS. That resulted in two neurologist visits and an MRI finding nothing. But symptoms continued and Lyrica 50mg and 75 mg was needed to function and sleep. This lasted with varying degrees of intensity about the life of the vaccine and happened again with a Fluvirin given on 10/17/214 with symptoms starting on the 31st and lasting for quite awhile requiring Lyrica.
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| 68 | 2021-03-18 | feeling hot |
Extreme nausea, abdominal cramping, diarrhea, dizziness. Also headache and warm face (low fever) occ...
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Extreme nausea, abdominal cramping, diarrhea, dizziness. Also headache and warm face (low fever) occurring for 2 hours , beginning 4 hours after vaccination. Then a little less severe for the following 2 hours. Then further diminishing over the next four hours. Felt OK after 12 hours.
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| 68 | 2021-03-18 | pain in extremity |
I had significant pain at site of injection starting about 1 day after initial injection. From that...
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I had significant pain at site of injection starting about 1 day after initial injection. From that time unitl now I experienced shoulder and muscular pain intermittently around the injection site and throughout my left shoulder region. Sharp pains occurred with certain movements and at unexpected time. On 3/18/21 I experienced serious pain at the injection site and radiating down my left arm. I was unable to move my arm due to the pain. The pain was so severe (10 out of 10) that I couldn't sleep and I was concern it might be a heart attack. I went to an urgent care center, They did an EKG and assuerd me that it wasn't a heart attack. The physican diagnosed a frozen shoulder and asked about the timing of my Covid vaccine. I followed up the next day with my primary care physician and he suggested I report this as possibly related to vaccination. The pain today is still centered right at the injection site.
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| 68 | 2021-03-18 | pain in extremity |
Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left a...
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Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunization. Medical history included sulfa allergy (reported as sulfa based) from an unknown date and unknown if ongoing. Concomitant medications reported as in two weeks included unspecified allergy nasal spray. The patient previously took codeine and experienced allergy. On 12Feb2021, at 13:00, the patient experienced initial injection slight pain; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy. There were no treatments provided for the events, and no noted COVID testing post vaccination. The outcome of events was not recovered.
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| 68 | 2021-03-18 | pain in extremity |
RECEIVED SECOND DOSE OF PFIZER ON TUESDAY (3/16) AND HAD SLIGHT HEADACHE THRU THE NIGHT, BUT TOOK NO...
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RECEIVED SECOND DOSE OF PFIZER ON TUESDAY (3/16) AND HAD SLIGHT HEADACHE THRU THE NIGHT, BUT TOOK NOTICE OF ITCHING ON RIGHT CALF ON THURSDAY. DISCOVERED I HAD A VERY RED RASH/HIVE? FROM MY RIGHT KNEE MOST OF THE WAY TO MY ANKLE AND SEVERAL SMALLER BLOTCHES. THEY WERE ITCHY AND HOT. USED SUNBURN LOTION WHICH HELPED SOME WITH ITCHING. IT SEEMS TO BE FADING BUT STILL ITCHY. THOUGHT IT SHOULD BE REPORTED...BUT CERTAINLY BETTER THAN COVID.
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| 68 | 2021-03-18 | inability to speak |
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci...
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She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
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| 68 | 2021-03-18 | hot flush, tingling |
Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands...
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Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands suddenly started tingling, like pins and needles. That was on Feb. 11th, and now, March 19th I still have tingling everywhere from my neck down to my feet. Mostly arms and legs. It has gotten worse at times, then is milder, I notice it most when I try to fall asleep. The paresthesia keeps me awake or wakes me up. It also makes my heartbeat increase, along with hot flashes. I've been to the ER two times, have taken antihistimines but they do not agree with me. My doctor thinks it's a neuropathic reaction to the virus and will go away but it's been over 5 weeks and is still there. I will see a neurologist soon to rule out other possible causes, but I've never had paresthesia before, so think it must have been the Pfizer vaccine.
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| 68 | 2021-03-18 | cold sweat |
Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point...
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Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point of almost fainting. I called 911 which I never would do normally but there was no one but me and I wasn?t sure what was happening. Medics took vitals and all was ok. By the time they arrived I was shaky but all other symptoms had gone.
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| 68 | 2021-03-18 | numbness |
felt numbness in both upper arms and lips. It progressed to part of my tongue; felt numbness in both...
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felt numbness in both upper arms and lips. It progressed to part of my tongue; felt numbness in both upper arms and lips. It progressed to part of my tongue; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 68-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 68 years old) as a single dose, for COVID-19 immunisation. The facility in which the vaccination was administered was a hospital. Medical history included Lung cancer, prior strokes from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications include Protonix, Lexapro, Atenolol, ASA, Crestor. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 15Feb2021 at 09:15 the patient experienced felt numbness in both upper arms and lips. It progressed to part of my tongue. The clinical course is as follows Within 20 minutes after receiving the vaccine. Patient felt numbness in both upper arms and lips. It progresses to part of her tongue. The numbness in my upper arms was fleeting. The numbness in lips and tongue dissipated approximately 7 hours later. There was no progression of oral numbness. The adverse event resulted in an emergency room visit. No Treatment was given. The clinical outcome of the events numbness in both upper arms and lips. it progressed to part of my tongue was recovered on 15Feb2021. .
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| 68 | 2021-03-19 | tingling | Patient C/O tingling in lips, throat and fingers. She was given Allegra and taken to ER |
| 68 | 2021-03-19 | tremor |
Patient had a metallic taste in the back of her throat. She has a history of several allergies and s...
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Patient had a metallic taste in the back of her throat. She has a history of several allergies and she felt like she was going to have an allergic reaction. She became anxious and had slight shaking in her hands and legs. She removed her mask and jacket and sat calmly. We took her BP and Pulse Ox and she was normal. She sat for 1 hour and then felt better to leave. I followed-up with her 4 hrs later and she was okay but just didn't feel right. I advised her to come to the ER if her symptoms worsened.
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| 68 | 2021-03-19 | breast pain |
Soreness and itching at injection site. Swollen lymph node on my collar bone. Soreness in left brea...
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Soreness and itching at injection site. Swollen lymph node on my collar bone. Soreness in left breast.
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| 68 | 2021-03-20 | pain in extremity |
1st night: arm pain peaked in the middle of the night, but better by morning 3 days after injection...
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1st night: arm pain peaked in the middle of the night, but better by morning 3 days after injection: had pain in left shoulder blade and about 5-6" radius of very tender scalp that hurt to barely touch 4 days: left shoulder blade pain better....tender scalp remains 5 days: pain has moved up toward shoulder..lesser pain on scalp 6 days: left shoulder pain gone, but now have arthritis type pain in left shoulder and back area and neck area...still some scalp pain 7 days: continued arthritis type pain in left shoulder and back area and neck area...still some scalp pain 8 days: still a little arthritis pain in left shoulder and back area and still a little scalp pain for the shoulder blade, shoulder, back and neck pain, I used ice
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| 68 | 2021-03-20 | pain in extremity |
Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; ...
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Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
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| 68 | 2021-03-20 | discomfort |
No problems until around 1PM noticed a irritation, marked with bright red areas on inside of upper ...
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No problems until around 1PM noticed a irritation, marked with bright red areas on inside of upper portion of cheeks and some redness under top lip. Progressed quickly - and around 4PM noticed discomfort increasing. Around 1430 my upper lip began to swell and it looked like their was fluid under reddness. On my way to ER the swelling continued , and got worse traveling to the other side of my lips and above my lips to under my nose. While at ER my bottom lip started to also swell.
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| 68 | 2021-03-20 | pain in extremity | Sore arm, headache, fatigue |
| 68 | 2021-03-20 | muscle spasms |
cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up...
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cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-03-20 | nerve pain |
she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This ...
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she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This is a spontaneous report from a contactable consumer via medical information. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number : EK9231; expiry date : Apr2021) via an unspecified route of administration, in Arm Right on 05Jan2021 10:00 as single dose for protect against covid. The patient medical history and concomitant medications. The patient previously took mortin and had allergy ongoing, influenza vaccine (Flu shot) and had pain (She got a Flu shot 3 years ago in her left arm and the pain didn't go away for 9 months. States that for the next 2 years she got her flu shot in the right arm). Patient had the 1st dose on 05Jan2021, and was due next Friday for her 2nd dose, but she has come down with shingles on her opposite arm on 11Jan2021. She doesn't know if it has anything to do with the vaccine. Has it been reported before, and can she get the 2nd dose. Shingles was reported as worsened. She has shingles on the left arm, hand, wrist, and fingers; she was in a lot of nerve pain in Jan2021. The pain started 6 days after she got the vaccine; pain and tingling. Then 2-3 days later, she noticed some red marks by her elbow. She went to a clinic and was diagnosed with Shingles and was started on Valacyclovir 1gm tablet, 1 tablet 3 times daily for 7 days. The next day she called the doctor, and had a tele-visit and the doctor was able to see some lesions. She told the doctor how much pain she was in, so the doctor prescribed Gabapentin 100mg. She was told to start off with 1 daily at night to help with sleep because she wasn't sleeping because the pain was so bad, then after 5 days she can take 1 twice daily as needed. States that it hasn't been 5 days yet, so she was still only taking it once at night, and she was able to sleep over 4 hours at a time, which was great. She wishes she could jump ahead and start taking it twice a day already because she was in pain all day long, but she was following the directions. States that the pharmacist said she could take Tylenol in between, so that was what she is doing. States that she was getting more lesions, but they are faint and are mostly on the palms of her hands and in between her fingers. The outcome of the event Shingles was recovered 11Jan2021; for Nerve pain was unknown.
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| 68 | 2021-03-21 | feeling cold, weakness |
Blacked out completely while driving home on the highway about 50 minutes after the vaccine was admi...
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Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period.. After awakening, nauseated, vomiting, woozy, dizzy, felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made. Examined and tests done at Emergency room.
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| 68 | 2021-03-21 | pain in extremity |
Got the vaccine, and had no problems as she was busy in the house, cleaning. Later during the day w...
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Got the vaccine, and had no problems as she was busy in the house, cleaning. Later during the day when she went to check a note without her glasses was not able to see, which she was able to do before she got the vaccine. She cannot read anything close up right now without looking through her bifocals, which she did not have any blurry vision before the vaccine. She now cannot read anything far away without blurry vision, mainly distance reading, but again was able to do that before. Before her vaccine she used glasses for close up reading only. Her arm was sore for a day and a night and has no problems with the injection site itself. She does have an appointment with an Ophthalmologist is tomorrow.
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| 68 | 2021-03-21 | pain in extremity |
Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; A...
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Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; Arm Pain, Left; Can't hardly use her left arm, it is so sore; This is a spontaneous report from a contactable nurse reported for herself. A 68-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9261, via unknown route on 12Feb2021 12:00 (at the age of 68-years-old) at left arm for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. Vaccination Facility Type: Hospital. On 12Feb2021 the patient experienced left arm pain, pain chest, can't hardly use her left arm, it is so sore and on 14Feb2021 Pain radiating from chest to left side of neck and Swollen Lymph Nodes. Caller stated that she was thinking needs to go to the Emergency Room because it could be her lymph nodes, a blood clot, or her heart. She stated that she has been experiencing this since day one and nobody else has had side effects but her. She stated that this was out of the ordinary and according to the list she was given, it was not listed as a side effect. She was supposed to go tomorrow to get second shot, but she didn't think that she was going to be able to do it. No emergency room or physician office required. The outcome of the events at the time of last observation was reported as not recovered. Treatment was none. The events were assessed as serious, important medical events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-21 | pain in extremity, feeling cold | fatigue, nausea, headeache, extreme cold and pain in arm. |
| 68 | 2021-03-21 | pain in extremity |
pain in arm, mild bruising, headache. Headache got worse on Wednesday , it is getting better today...
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pain in arm, mild bruising, headache. Headache got worse on Wednesday , it is getting better today. Patient has been taking Tylenol PM patient no longer has headaches, feeling much better. Taking Tylenol PM as needed.
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| 68 | 2021-03-22 | pain in extremity |
Soreness that does not resolve. Stiffness and inability to use full range of motion. After a month...
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Soreness that does not resolve. Stiffness and inability to use full range of motion. After a month my arm still aches and makes routine movement difficult.
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| 68 | 2021-03-22 | pain in extremity |
very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, bra...
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very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, brain fog, all my skin felt like it a bad sunburn its still not back to my normal state, cronic sinus issues for about 2 weeks with headaches,
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| 68 | 2021-03-23 | pain in extremity |
Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101...
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Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101.9) Body ache Chills Upset stomach/ no appetite
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| 68 | 2021-03-23 | weakness, cold sweat |
Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,...
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Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,nausea, short of breath ,dry mouth ,dehydrated, very bad I though Iwas going to pass out at any time,weak.
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| 68 | 2021-03-23 | pain in extremity |
slight rash on chest; sore arm; This is a spontaneous report from a contactable consumer (patient). ...
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slight rash on chest; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 09:15 (Lot Number: EL9269) at the age of 68 years old as single dose for covid-19 immunisation. Medical history included known allergies: iodine, shellfish, penicillin, Cipro, Nitrofurantoin, wool. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced sore arm, slight rash on chest on 20Feb2021 15:30. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.
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| 68 | 2021-03-24 | burning sensation |
Client c/o burning sensation at the tip of the tongue. Client seen and assessed by EMT and vitals a...
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Client c/o burning sensation at the tip of the tongue. Client seen and assessed by EMT and vitals are as follows BP 150/89, HR 78, O2 97. Client denies any pain or other symptoms of the moment and no swelling of the tongue note. Client able to verbalize with ease. Client advise to contact pcp for any other symptoms arise and cleared to go home by EMT.
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| 68 | 2021-03-24 | feeling cold, tremor |
Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry...
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Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry and could not focus on anything- trouble standing up and not falling over- started at 6:30 Sunday morning and gone by 1 - except very fatigued, (slept mostly for 3 days) shaky (trembling) , no appetite , headache and chills- lasting thru to Thursday morning. Was very scary!
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| 68 | 2021-03-24 | hot flush |
Since the first vaccine, i started and still have up to date hot flashes daily and some equal libriu...
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Since the first vaccine, i started and still have up to date hot flashes daily and some equal librium issues.
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| 68 | 2021-03-24 | tingling |
Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progr...
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Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progressing lack of bilateral lower extremity sensation and rapidly progressing within hours to complete paralysis with fecal and urinary incontinence
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| 68 | 2021-03-25 | tingling, facial paralysis, muscle twitching |
#Tingling in face - Ongoing intermittently since 6 Mar 2021 - Notes that symptoms started immediatel...
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#Tingling in face - Ongoing intermittently since 6 Mar 2021 - Notes that symptoms started immediately after she received her COVID vaccine and have progressively become more noticeable since then - She did not notify the post-observer that she was experiencing symptoms - Tingling starts in right eye and goes down into right lower lip with occasional twitching - slight facial droop on right lower cheek/mouth - Denies facial pain or eyelid drooping - Denies shortness of breath, chest pain/tightness
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| 68 | 2021-03-25 | pain in extremity |
Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spon...
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Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 12Feb2021 at 13:45 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included breast and colon cancer, thyroid surgery, controlled blood pressure (BP), and diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included trastuzumab (HERCEPTIN) infusions every 3 weeks from an unspecified date for cancer, pertuzumab (PERJETA) from an unknown date for cancer, anastrozole from an unknown date for cancer, levothyroxine sodium (SYNTHROID) from an unknown date for thyroid surgery, nadolol from an unknown date for controlled blood pressure, linagliptin (TRAJENTA) from an unknown date for diabetic, pantoprazole (PROTONIX) from an unknown date for an unknown indication, cetirizine (ZYRTEC) from an unknown date for an unknown indication, and "vita" from an unknown date for an unknown indication. The patient previously received penicillin, aspirin, and medications from yew pine tree from unspecified dates for unspecified indications and experienced allergy. On 06Feb2021 (as reported) the patient experienced tiredness. On "day 2" the patient experienced sore arm, stomach and intestinal issue, diarrhea and very unsettled stomach. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tiredness and sore arm were recovered on an unspecified date. The outcomes of stomach and intestinal issues, diarrhea and very unsettled stomach were recovered on "day 5". It was also reported that since the vaccine, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 68 | 2021-03-25 | weakness |
a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low f...
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a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low fever, body aches which continued from the 15th untill today 26th. lost 12 lb during this time, Weakness. Have never been this sick! My husband also had the same shot, same day, and started getting ill 5 days later, Cough, fever, nausea, unable to sleep. He is still ill today with dry heaves.
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| 68 | 2021-03-26 | pain in extremity, paralysis |
Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shoo...
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Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shooting up and down the leg on the opposite side (R) with very bad joint pain. This went off & on through the night/early morning in the first 22 hrs after vaccination. Woke with most pain gone, L hand red and sore, minor headache. Through out the following week I have experienced difficult pain and instability of some joints.
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| 68 | 2021-03-27 | pain in extremity |
2 days: sore arm, fever, aches, extensive sleep days 3-10 vaccination arm swollen lymph nodes with ...
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2 days: sore arm, fever, aches, extensive sleep days 3-10 vaccination arm swollen lymph nodes with low grade fever
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| 68 | 2021-03-27 | muscle spasms | Double vision, droopy eyelids, fatigue, headache, cramps ( all within first 24 hours after shot) |
| 68 | 2021-03-28 | pain in extremity |
Two days after my second covid vaccine I had severe pain in both upper arms. I was unable to lift my...
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Two days after my second covid vaccine I had severe pain in both upper arms. I was unable to lift my arms above shoulder level. I also had weakness in both arms. The pain was worse in bed and I was unable to lift my arms at all from my sides. I saw Dr my fmaily doctor and was started on prednisone for 6 days. the pain subsided and movement returned. After the 6 days the pain returned as before. I also saw a pain specialist and 2 more visits to Family Dr. I had a second round of prednisone for 2 weeks and pain subsided mostly but has returned but not as bad after 2 weeks. I had 5 sessions of PT that helped somewhat
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| 68 | 2021-03-28 | weakness |
body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; d...
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body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; dry cough; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number reported as "G or E N6202"), intramuscular in left arm on 27Feb2021 (age at vaccination 68-year-old) at 11.30 at single dose for COVID-19 immunization. She is due to take the second dose of the vaccine on 20Mar2021. Medical history included: she has history of AFIB but has been in regular rhythm and has not taken any medications since 3-4 years ago. Her blood pressure is so low and she was falling all the time, was dizzy and bumping into wall. The doctor said it was a good thing she is off. Her blood pressure is still 90's/60/s. She got shingles two shots and she got it last fall. Those were pretty awful. She had a lot of local tenderness, trouble lifting arm up and the next two days, she felt blah and had pain in clavicle and scapula on left side. That pain in the bone lasted about a week afterwards; diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, she has had low white cell all of her adult life (she has gone between 3.5 and 4.0). Family medical history: Cardiac history. Concomitant medication included: eye vitamins and that kind of stuff. She did not take Tylenol or aspirin two days prior. On 09Mar2021, 11 days after getting the first dose of the vaccine, she had symptoms namely sore throat, chills, body ache from head to toe, dry cough, fever and weakness. She said that it lasted for 36 hours. She felt so crappy on 09Mar she did not take her temperature. She did not take it until 10Mar2021 when it reached a maximum of 101.8 degrees. Patient said she now feels pretty good except she has no energy at times. She wondered if she had COVID, so she got a test on 10Mar2021 and it was negative. Patient reported that she actually had a sore throat for about a year. That may not have been started with the vaccine, but it may have been exacerbated. She thinks she may have Reflux. She made an appointment with her gastroenterologist. She said her throat was red when she went to Urgent care to get the COVID test. She has had a dry cough for about a year. That could be related as well to the reflux. That did not seem to increase since the vaccine. Reporter considered events fever, chills and ached from head to toe as medically significant. Outcome of events sore throat worsening, asthenia was not recovered, chills, ached from head to toe, fever was recovering, of event cough was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Fever, Ache, and Chills cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-28 | flushing |
numbness on lips and appeared flushed in the face. 174/82, 195/85, 87, 98%. Transported to assess hy...
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numbness on lips and appeared flushed in the face. 174/82, 195/85, 87, 98%. Transported to assess hypertension
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| 68 | 2021-03-29 | tingling |
The tip of my tongue became numb and slightly tingly.; The tip of my tongue became numb and slightly...
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The tip of my tongue became numb and slightly tingly.; The tip of my tongue became numb and slightly tingly / around my mouth and on my cheeks became slightly tingly; around my mouth and on my cheeks became slightly tingly; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included arthritis, anaphylactic reaction to shellfish (patient carried an epinephrine (EPIPEN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included omeprazole and calcium carbonate/colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within 4 weeks of the vaccination. The patient previously took ibuprofen and had an anaphylactic reaction (possibly) and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN9581) on 28Jan2021 at 09:00 (at the age of 68-years-old) in the left arm for COVID-19 immunization. On 24Feb2021 at 09:30, the tip of the patient's tongue became numb and sightly tingly. Also, around the patient's mouth and her cheeks became slightly tingly. This lasted about 45 minutes. The patient was not treated for the events. Since the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of "the tip of my tongue became numb and slightly tingly / around my mouth and on my cheeks became slightly tingly" was resolved on 24Feb2021 at 10:15.
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| 68 | 2021-03-29 | tension headache |
pt states that immediately after taking the vax she got light headed and her limbs felt very very he...
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pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy. Her BP was up to 192/90. They had her sit to monitor her BP and she became nauseas. She went to the ER. They continued to monitor her BP and she was given IV Benadryl. The heaviness in her limbs lasted many hours. Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home. Walking to her vehicle she had the dizziness, heaviness and was light headed again. When she got home she went to bed. Pt woke up having heart palpations. No chest pain or SOB. These palpitations lasted about 15 minutes. On 3/30/2021 she has some fatigue and a tightness around the top of her head. Pt has a FU appt w/ PCP on 3/31/2021.
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| 68 | 2021-03-30 | numbness, tingling |
Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingli...
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Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingling; Struggle to do anything with arms or hands; Struggle to walk; Exacerbation of MS following first dose of vaccine; Legs are weak, numb, tingly; Legs are weak, numb, tingly; Legs are weak, numb, tingly; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 04Mar2021 08:00 as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history included multiple sclerosis from 1994 and ongoing Verbatim: MS. There were no concomitant medications. Historical vaccine included Tdap vaccine (DPT VACCINE) on 18Feb2016 for vaccination. The patient stated that she was looking for direction as well as reporting an exacerbation of MS following her first dose of the vaccine, clarified as the Pfizer Covid-19 vaccine, on 04Mar2021. Weight: Caller stated she would give her Covid weight. HCP: Caller reported that she is unsure of MD zip code. She reported that the phone number for her MD ends in DOCS but she did not know which numbers that corresponded to. Caller reported that she did not experience any of the common side effects from the first dose of the Covid-19 vaccine. She did not experience a sore arm, fever, muscle aches, none of that. She reported that she did not have any side effects until the afternoon of Saturday, 06Mar2021. Caller reported that she's had MS for many many years and that it has been in what she calls remission for a long time. She stated that the last exacerbation she experienced was following a Tdap vaccination five years before. Because of this experience, when the Covid vaccine came out, she went through her doctor to see what she should do, if she should get it. Her doctor recommended that she get the Covid-19 vaccine, but told the caller that she should make sure to go to a health care facility to receive it instead of drugstore or a clinic due to her experience following the Tdap vaccine in 2016. Caller reports that she is now having a similar exacerbation following the Covid-19 vaccine. Exacerbation of MS: Caller stated that it is an ongoing exacerbation that is not getting better. She stated that she's sure that it will get better, but she is not sure what she should do about the second dose. Legs weak, numb, tingly: Caller reported that the weakness, numbness, and tingling in her legs was progressive. She stated that the weakness, numbness, and tingling began on Saturday afternoon, 06Mar2021, in her feet and lower legs, and had then progressed to her thighs by Sunday 07Mar2021 or Monday 08Mar2021. Arms are weak, numb, tingly: Caller reported that she noticed on Sunday, 07Mar2021 that her hands were a little clumsy. She reported that throughout the day of Sunday, 07Mar2021 and Monday, 08Mar2021, the numbness and tingling progressed into her upper arm. Facial tingling: Caller originally stated that she has been experiencing a lot of nerve sensation, then clarified as facial tingling, in particular around the mouth, below the nose, and on both sides of her face. She stated that it began on Sunday, 07Mar2021 and was intermittently present on 08Mar2021 probably into 09Mar2021, then it just went away. She stated that it would come and go. Caller reported that while she is able to walk and has not had to use her wheelchair, that it is a struggle to walk. She also reported that it is a struggle to do things with her arms and hands. She stated that if she wanted to eat, in order to pick up the fork she would probably be using 2 hands to get the fork up but can use it once it's in her hands. She also reported that a pencil is difficult to pick up as well, stating that she would need to use both hands to pick it up but would be able to use the pencil once she had picked it up. Caller reported that the tingling comes and goes, and she experiences varying degrees of numbness. She reported that they are a little numb throughout the day and it may get worse depending on what she's doing. She stated that she isn't a sitter, she has to get up and move. Caller reported that she called her physician, about the side effects she was experiencing and they instructed her to go to the Emergency Room. She stated that their concern was what was going on and if it could be Guillain Barre disease, which she stated is extremely rare. Caller reported that when she went to the Emergency Room on 09Mar2021, they did not really do any tests. She stated that in order to see if there were any new lesions for the MS, they would have to do an MRI of her brain. Caller reported that they did not believe that there were any new lesions, that they thought it was old lesions. Caller reported that they told her to go home and make an appointment with the neurology resident clinic for that week, clarified as last week, week of 09Mar2021. Caller reported that she called the neurology clinic as she does not currently have a neurologist, and they informed her that they would not be able to get her in for an appointment until the end of Apr2021. She stated this was not doing her much good. Caller stated that they had wanted to admit her to the hospital, but told her that she could go home if she promised to follow up with the neurology resident clinic. Caller expressed some frustration, stating that she was really trying to reach out to see what she should do regarding the second dose. Her physician tells her to go to the Emergency Room, the Emergency Room tells her to go to neurology. She wants to know what will the second dose do. She stated that she called the (state) chapter of the national MS society this morning, where they informed her that they had not heard any reports of exacerbations from the Covid-19 vaccine. Caller states that getting additional doses of the Covid-19 vaccine is a lifelong decision. She stated that Covid may not always be a pandemic, but it could come back like a yearly flu. She stated that because additional doses of the Covid-19 vaccine could be required, she wanted guidance on how to proceed. Her second dose of the Covid-19 vaccine is scheduled for 25Mar2021. Clinical outcome of facial tingling was recovered on 09Mar2021, while for the rest of the events was not recovered. Information about Batch/Lot number has been requested.
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| 68 | 2021-03-30 | feeling hot |
Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body mu...
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Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
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| 68 | 2021-03-30 | numbness, facial paralysis |
Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; f...
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Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208, expiration date: 30Jun2021) via intramuscular in the left arm on 12Mar2021 at 14:10 at single dose for COVID-19 immunisation. Medical history included hyperlipidemia, pneumonia and flu. The patient had family medical history of diabetes. Concomitant medications included estrogens conjugated (PREMARIN) ongoing. The patient was not pregnant. The patient no other vaccine in four weeks or other medications in two weeks. The left side of the patient's face became swollen and inflamed. Five days later the left side of her face was still swollen and sore. The left side of her face was drooping. Events started date was 12Mar2021 at 15:00 PM. No treatment for AE was received, except events "mass/swelling on her face" and "Her left arm and face were numb". The patient had no COVID prior vaccination, no COVID tested post vaccination. A nurse reported that the 2nd dose was scheduled for 05Apr2021. The patient had last blood work (reported as BW) on Sep2020 with comments: normal. The left side of patient's face was drooping on 14Mar2021. The nurse stated patient went to ER. Her left arm and face were numb. They noticed a mass/swelling on her face. Outcome of the events "mass/swelling on her face", "Her left arm and face were numb" was unknown, of the other events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to event the left side of her face is drooping is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-30 | pain in extremity |
MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms...
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MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
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| 68 | 2021-03-30 | tremor |
Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneo...
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Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 at 14:00 (at the age of 68-years-old) at a single dose for covid-19 immunisation. Medical history included bronchiectasis and dysthymia. Allergies to medications, food, or other products included Rash with amoxicillin. Concomitant medication patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ovata (METAMUCIL [PLANTAGO OVATA]). The patient previously took amoxicillin and experienced rash. The patient experienced nausea, vomiting, chills, stomach pain, slight headache and uncontrollable shaking on 28Jan2021 at 21:30 PM. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering form all the events.
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| 68 | 2021-03-30 | feeling hot, flushing |
blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; s...
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blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; she was lightheaded; feel chest pressure; facial flushing and warmth; facial flushing and warmth; redness on her neck and chest; This is a spontaneous report from a contactable retired registered nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right deltoid on 06Mar2021 10:09 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for anaphylaxis prophylaxis; famotidine (PEPCID) taken for anaphylaxis prophylaxis; cetirizine hydrochloride (ZYRTEC) taken for anaphylaxis prophylaxis; methylprednisolone acetate (MEDROL) taken for anaphylaxis prophylaxis. The patient previously received H1N1 vaccine (Sanofi Pasteur, lot number: UP006AA, expiry date: 15Mar2011) on 27Oct2009 and experienced anaphylaxis. Patient had no other vaccines on the same day as the suspect product. The patient experienced blood pressure was checked and it had skyrocketed to 204/110 (hospitalization (from 06Mar2021 to 08Mar2021)) on 06Mar2021, felt chest pressure on 06Mar2021 10:29, facial flushing and warmth on 06Mar2021 10:29, redness on her neck and chest on 06Mar2021 10:29, she was lightheaded on 08Mar2021, blood pressure had dropped to 95/58 on 08Mar2021 21:43. Clinical course: Caller states that she received her first dose of the product on 06Mar at 10:09am. Caller states that to provide some history, in Oct2009, she had anaphylaxis from the H1N1 Vaccine and in 2017, she finally found an allergist who specialized in medication allergies. Caller states that since then, any time she takes the Flu Vaccine, she pre medicates with a combination of antihistamines and a proton pump inhibitor. Caller states that in preparation of the COVID vaccine, her allergist prescribed her a Medro Dose pack and antihistamines and a proton pump inhibitor for preparation, starting three days prior to the vaccine, in order to prevent anaphylaxis. Caller states that 20 minutes post receiving the vaccine, she started to feel chest pressure, she had facial flushing and warmth, and redness on her neck and chest. Caller states that her blood pressure was checked and it had skyrocketed to 204/110. Caller states that she did not have anaphylaxis though. Caller reports that with her blood pressure being so high, they had to call paramedics, and the caller went via ambulance to the ER at about 1130am on 06Mar2021. Caller states that she spent 6 hours in the ER, and then she was put in the hospital for the next two days. Caller reports she was admitted to the hospital for her blood pressure because the ER could not get it below 185 systolic. Caller states that all her labs were negative for everything, and they checked heart attack markers that were all negative. Caller had an EKG and a stress test and those were both negative as well. Caller had blood work done, EKG and stress test that were all normal. But caller states that it took a while to get her blood pressure down. Caller states that she was talking with her allergist and he said that if she gets the second dose of the vaccine, it would need to be in a hospital setting, with an IV already in place, and caller does not think insurance will cover all that. Caller states that she did speak with an Infectious Disease doctor, who told the caller that she needs to get the second dose of the product for COVID coverage, but how would the caller move forward with getting the second dose, following what happened to her? Caller is wondering how much protection the vaccine provides after just one dose? Caller is also wondering, the hospital gave her at least two or three doses of Solu-Medrol, and caller is wondering if having received steroids in the hospital would reduce the efficacy of the COVID vaccine, and if so, by how much? Event Details: Caller had the vaccine, and the reaction started on 06Mar2021, and she was admitted on the same day. Caller was discharged from the hospital on 08Mar2021 around 330pm. Caller reports that the morning of her discharge from the hospital, her blood pressure had gotten back to 135 systolic, but before it was time for her to go down for the stress test, it was back to 159, and down while she was in nuclear medicine, it got to 160 systolic. Caller reports that the day she was discharged, she went home and got settled in, and she took her blood pressure and it was down to 128/78, but then that evening, things got spinning around her, and lights were flickering in her head, and she was lightheaded, and her blood pressure was 110/63 at 9pm and by 9:43pm, her blood pressure had dropped to 95/58. Caller states that it has not been a fun trip. Caller reports that the next morning, her blood pressure was back up to 139/78, but then later in the day she was lightheaded again, and by 9am her blood pressure was 111/69. Caller states that since then, her systolic blood pressure has been between 110 and 126. Caller states that there is nothing else she can think of. Caller states that she felt fine the morning of getting the COVID vaccine, she was looking forward to getting it, and she got herself on the list and made sure to consult with her allergist so that she would have prophylactic medications ready to go. Caller states that she does have a history of hypertension, but her blood pressure was 128/72 the morning of getting the COVID vaccine. The outcome of the events Blood pressure high and Blood pressure dropped was recovering, of the other events was unknown. The reporter considered the event blood pressure had skyrocketed to 204/110 was related to the suspect vaccine.; Sender's Comments: Based on the temporal association and known drug safety profile, a possible contributory role of vaccination with BNT162B2 to the reported event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 68 | 2021-03-30 | pain in extremity |
extreme fatigue; body aches; very sore arm; This is a spontaneous report from a contactable consumer...
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extreme fatigue; body aches; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in Left arm on 29Jan2021, 09:15 AM (at the age of 68-year-old) as a single dose for COVID-19 immunisation in Public Health Clinic/facility. The patient's medical history included Type 2 Diabetes, High BP (blood pressure), High Cholesterol, Asthma. List of any other medications the patient received within 2 weeks of vaccination: Yes (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. About 48 hours after injection, on 31Jan2021 09:00 am, the patient experienced extreme fatigue, body aches, very sore arm. The reporter assessed the events as non serious. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.
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| 68 | 2021-03-30 | tingling |
light headed/dizzy constantly; tingling in face; This is a spontaneous report from a contactable non...
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light headed/dizzy constantly; tingling in face; This is a spontaneous report from a contactable non pregnant female consumer reported for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3249, Expiration date was not reported), via an unspecified route of administration, in arm right on 23Jan2021 03:15 as single dose for covid-19 immunisation. Medical history included heart burn. Patient did not have allergies to medications, food, or other products. Concomitant medications included oxybutynin, omeprazole and famotidine all are taken for an unspecified indication, start and stop date were not reported. The patient experienced lightheaded/dizzy and tingling in face on 27Jan2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.
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| 68 | 2021-03-30 | weakness |
sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was tr...
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sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was trying to gain her strength from being sick; her head hurt from the fall; her head hurt from the fall; she had to walk slower because she got dizzy; This is a spontaneous report from Pfizer. A 68-year-old female contactable consumer reporting for herself received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6200, expiry date Jun2021) on 16Feb2021 at 14:45, in left arm, for COVID-19 immunisation. The patient received the COVID-19 vaccine for age and several comorbidities. No other vaccines were administered within 4 weeks. Medical history included ongoing high blood pressure diagnosed 25 years ago, ongoing hypothyroidism diagnosed 25 years ago, liver resection in 2007 for a benign tumor (she had not been sick and it was found accidentally), liver bile duct stopped up from 2017 and ongoing (due to scar tissue from the liver resection surgery; she had an emergency stent placed in her bile duct), chronic Crohn's disease, ongoing thyroid disorder. The patient previously received flu vaccines on unspecified dates for immunization experiencing unspecified side effects some years ago, but this past year she didn't have a reaction. The patient previously received pneumonia shots on unspecified dates since few years. Family history included gallbladder problems in her sisters and mother. Concomitant medications included oral amlodipine (manufacturer: Lupin, expiry date: 23Feb2022) from an unspecified date (a few years ago) and ongoing, 5 mg at night, for blood pressure, oral telmisartan (MICARDIS; manufacturer: Alembic, expiry date: 02Mar2022) from an unspecified date (few years ago) and ongoing, 80 mg at night, for blood pressure, oral metoprolol (manufacturer: Mylan, expiry date: 09Feb2022), from an unspecified date (few years ago) and ongoing, 25 mg twice daily, morning and night, for blood pressure, oral levothyroxine sodium (SYNTHROID) from an unspecified date (20 years ago or more), 75 ug daily in morning, with water, hour before any eating or other medications, for thyroid disorder. The patient experienced sepsis on 25Feb2021 with outcome of recovered on 03Mar2021, gallbladder attack on 24Feb2021 with outcome of recovering, passed out from the gallbladder attack on an unspecified date in 2021 with outcome of unknown, got dizzy on an unspecified date in 2021 with outcome of not recovered, weakness from being hospitalized on an unspecified date in 2021 with outcome of not recovered, she was trying to gain her strength from being sick on an unspecified date in 2021 with outcome of unknown, her head hurt from the fall on an unspecified date with outcome of unknown. The patient was hospitalized for sepsis due to a gallbladder attack from 25Feb2021 to 03Mar2021. The events gallbladder attack and sepsis required also an ER visit. They did not require a physician office visit. Additional clinical course of the events included the following details. Gallbladder attack turned into infection/sepsis quickly. She previously had an emergency stent placed in her bile duct and now there was a stone in the bile duct and she was unsure if it was related; they will either remove her gallbladder or place a permanent stent. They removed stones and "goop" and placed a stent. Her gallbladder still needed to be operated on, but she was not sick with sepsis anymore. Regarding gallbladder attack the patient reported that it was controlled until further tests and surgery were performed. They couldn't do the surgery due to the infection which had cleared up but she did not want the surgery right now. A stent was placed in the duct until something was done and the stone will be crushed eventually. The patient passed out from the gallbladder attack. She never passed out, she had only ever passed out one other time in her 20's where she stood up too fast. The patient reported that she had to walk slower because she got dizzy and she was trying to adjust to getting home. She walked to the bathroom, used it, and her husband heard a thump while he was using the other bathroom. She was looking at the thermostat and fell in the den and she was surprised she didn't hit anything. Her head hurt from the fall. Sepsis: caller reported that as soon as she went to the ER, she was diagnosed with sepsis. Sepsis resolved the day she was discharged from hospital and when she was dismissed all tests were negative for sepsis. She went home on antibiotics for security for another week after discharge from hospital. Dizzy: it was just trying to get her strength up. She'll just be doing nothing and getting up too fast, it happened to any old person with blood pressure medicines. Dizziness began before she went into the hospital. She was experiencing weakness from being hospitalized and she was trying to gain her strength from being sick. Weakness began during her hospital admission and it was ongoing. On 03Mar2021 the patient underwent lab tests and procedures which included haematocrit: 30.4 %, haemoglobin: 10.4 g/dl (not in normal range yet), CMP: within normal limits (all results were within normal limits, including sodium and potassium), platelet count: 159, RBC count: 3.33 (supposed to be 3.9 or more but could have gotten better by now), WBC: 6.1 x10?/L, blood cultures: the results were not yet listed but sepsis was gone according to discharge blood work. She went to the doctor regularly. Her doctor knew how sensitive that was with her, but that her side effects were probably no more than anyone that experienced that. In some years she did not experience adverse events, specifically she did not with her flu vaccine in 2020. She has had side effects that had made her feel ill for 2-3 days and her niece was a nurse and thought she was making it up. The patient was advised to wait for the 2nd dose, she was unable to get it as scheduled on 08Mar2021. In meantime between receiving her first dose and her appointment for her second dose on 08Mar2021, she was hospitalized. The patient was just coming out of the hospital before 08Mar2021 and she still did not feel well so she cancelled the appointment. The hospital doctors, as well as the doctors approaching more tests with her gallbladder, recommended to not get the second dose as scheduled on 08Mar2021, but they could not recommend how or when to get it.
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| 68 | 2021-04-06 | tremor, feeling cold, migraine |
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo...
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Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
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| 68 | 2021-04-07 | weakness |
Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased...
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Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased level of care. Patient was admitted to outlying hospital with COVID-19 infection with shortness of breath, cough, fever, weakness, fatigue with decreased oral intake on 3/28/21. Patient required oxygen and was treated with remdesivir, steroids, and antibiotics. Patient was discharged to home with oxygen.
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| 68 | 2021-04-08 | nerve pain |
Was given 2nd shot March 22 and within 12 hours I had what I would call shooting nerve pain on t...
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Was given 2nd shot March 22 and within 12 hours I had what I would call shooting nerve pain on the level pain of shingles except it was everywhere. Next day I hurt all over. Wednesday some recovered, Thursday I went to work. Friday I would have said I was 100% till 3:30pm. I had adominal pain. Went to ER and was diagnoised with appendicitus. Had surgery next morning.
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| 68 | 2021-04-12 | weakness |
Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion...
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Patient presented with weakness and AMS. On admission, patient had severe hyponatremia and confusion continued as was also found to have supratherapeutic tacrolimus level. Patient started experiencing respiratory symptoms on day 2 of admission requiring O2 and treatment for COVID.
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| 68 | 2021-04-17 | tension headache |
feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head ...
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feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown. As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 68 | 2021-04-18 | inability to speak, speech disorder, pain in extremity, muscle twitching, muscle spasms, burning sensation, numbness, involuntary muscle movements, discomfort, tingling |
01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I e...
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01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
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| 68 | 2021-04-19 | weakness |
A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day...
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A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day. Five days after the vaccination I started to go into a sweat if I exerted myself too much. I continued to have a dizzy head and my stamina was greatly reduced. I used to ride my exercise bike for 90 -150 minutes a day but after the vaccine I could only go 20 minutes the first week and then I got progressively weaker and more dizzy. I could barely walk a half block. I also experienced some shortness of breath and a racing heart at times. The third week out was the worse. I could hardly care for myself. I started to get a lot of pain behind my eyes and other sinus pressure. Also the lymph gland under my ear was swollen and painful. I was extremely tired for a couple of days at that point but have found it hard to sleep on most other nights. I have strange dreams that are almost like an hallucination. I also have head aches but they seem to have improved as the weeks have gone by, especially since I have been taking Aleve every day. I am unable to exercise and have very little energy still. The dizzy head continues to persist even 6 weeks out. I had this same kind of dizzy head in August when I had Covid but it went away in a week or two. I get dizzy just reading a book or looking at my piano music also. Having had Covid twice I am very confident that these symptoms were caused by this vaccination. It also seemed to make my blood sugar more volatile. The sad thing is that I was feeling perfectly normal when I went in! I am devastated by these symptoms and they have completely altered my life. I am so discouraged that they never go away. Some days I feel like I am improving and then they pop up again. I was a very active person and now I can hardly do anything. I think I got the shot too close to when I had covid and that it has triggered an immune response that is overwhelming my body. Will it ever get better? I can't stand to go on like this!
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| 68 | 2021-04-21 | pain in extremity |
Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact t...
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Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact time because we ate directly after the fifteen minute waiting period. I didn't notice the sensation until right after we ate. It lasted about three days and then was gone. It was strong enough for me to notice immediately and think how weird, and it was strong enough for me to notice it off and on the next three days-gradually lessening. I have also had a sore throat the whole week since the vaccination-it started the day after. It hasn't turned into a cold-maybe a little drippy nose occasionally so not sure if sinuses etc, but the sore throat is persistent. Occasionally I feel it up higher in the nasal-pharynx also. I didn't report to my doctor or treat in any way. And for statistics, my arm was sore for about two days. The worst was that evening and pretty mild after that.
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| 68 | 2021-04-24 | nerve pain |
appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain e...
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appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
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| 68 | 2021-04-24 | weakness |
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any ...
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chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
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| 68 | 2021-04-24 | one side paralysis, inability to speak |
stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other ...
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stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 05Feb2021 (at age of 68 years old, no pregnant, Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included type 1 diabetes, hypertension (HTN). The patient not had COVID prior vaccination also not had COVID tested post vaccination. No known allergies. Concomitant medication included insulin, lisinopril and Multi vitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Jan2021 at 03:00 P.M. (at age of 68 years old, Batch/Lot number unknown) as single dose for covid-19 immunization. The patient received 2nd Covid shot on 05Feb2021. Had a stroke on 14Feb2021 at 08:00 AM with R sided weakness and expressive aphagia. Stroke noted on MRI in L hemisphere, speech area. The patient had no idea if this was related to the Pfizer Covid vaccine. AE resulted in: Emergency room/department or urgent care, Hospitalization (1 day), Life threatening illness (immediate risk of death from the event). Treatment received for events included observation, Lovenox. The outcome of the events was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke, Weakness left or right side, and Expressive aphasia cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 68 | 2021-04-27 | weakness |
4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM exper...
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4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM experienced rapid onset of acute nausea and mild vertigo. 4-26-21 After a sound night's sleep by 7 AM, the above (4-25) symptoms diminished. However, by 10 AM nausea symptoms became acute AND vertigo symptoms markedly increased, making the room look like it was spinning. Patient was able to bed rest until 1 pm and felt much better with symptoms markedly diminishing to low level 'dull nausea'. 4-27-21 After sound sleep, all above symptoms tapered off, leaving patient with very low energy level, yet able to perform ADLs--and feeling more homeostasis by 8 PM.
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| 68 | 2021-04-27 | speech disorder, pain in extremity |
Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest;...
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Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest; nausea feeling in her chest; She gets this laryngitis; has trouble talking; She wants to make sure its not going into like a viral pneumonia; Flu-like symptoms; fever; achy; fatigue; Sore arm; Headache; This is a spontaneous report received from a contactable pharmacist (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: CER230) via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunisation. The medical history included flu and suspected COVID-19 both in Jan2020 to an unspecified date (she had a bad flu back in Jan2020, which could have been COVID because it was such a bad flu, over a year ago), ongoing asthma from an unspecified date (mild asthma) and chest nausea in Jan2020 to an unspecified date. The patient had no history of any adverse events following prior vaccinations. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the adverse event included an uncle that had asthma, but no one else had breathing issues. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR) and ipratropium bromide/salbutamol sulfate (DUONEB), both ongoing and taken for asthma on unspecified dates. Other products were also reported as "no". The patient did not receive any prior vaccinations within 4 weeks prior to the COVID-19 vaccine and did not receive any additional vaccines on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: 3N6202) via an unspecified route of administration on 24Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation. On 24Mar2021 the patient experienced sore arm and headache; on 25Mar2021 the patient experienced flu-like symptoms, fever, achy, fatigue; on 02Apr2021 the patient experienced asthma flare up, dry, hacky cough, pain and tightness in her chest, nausea feeling in her chest; on unspecified dates in Apr2021 the patient experienced she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia. The reporter classified the events headache and flu-like symptoms as non-serious. The patient called to report that she had an asthma flare up 10 days (as reported) after her second dose of COVID-19 vaccine on 24Mar2021. The patient stated that she did not get a flare up often, she had mild asthma. She usually got mild flare-ups since she did not have severe asthma. She stated it could be something else, but she had not had a flare-up like this since she had a bad flu back in Jan2020, which could have been COVID-19 because it was such a bad flu. That was over a year ago. She received her second vaccine on 24Mar2021, and the asthma flare up and hacking cough started on 02Apr2021. On the night of 24Mar2021, she started with a headache. She had the shot at 11 something and by that evening before she went to bed, she had a headache and a sore arm, but that was no big deal. Then on 25Mar2021, she started with flu like symptoms/fever. The headache persisted through that as well. At that point, she did not have tightness or the dry, hacky cough. By the middle of the day on 27Mar2021, her flu-like symptoms were gone. She would consider these to be "non-serious", it was what she expected, as it was seen from the paperwork of the vaccine. By 28Mar2021, all of her symptoms were gone prior to the flare-up. She had typical flu-like symptoms: fever, headache, achy, fatigue on the 2nd, 3rd, and into the 4th day but then they cleared up. By the evening of the 4th day, she started feeling fairly normal. She stated that they were mild flu symptoms. Her temperature was only 100 for about a day. She stated that that was expected. Then, she went into this flare-up about the 10th day after the vaccine. The first 3 or 4 days after the flare up began, the flare up was worsening. Then, she got it under a little bit of control, so she was not coughing all night and having to sit up as she was sleeping. Now, she was concerned about the pain and tightness in her chest and the hacky cough. She wanted to make sure it was not going into like a viral pneumonia or another thing. She did not know. She kept increasing her Advair use and was at the top of that. She was doing the duoneb which she did not usually have to do. She had not had to do that since Jan2020 when she had the 5-week flu, or it could have been COVID (they were calling it a hoax back then). She was using her duoneb 4 times a day and now she was using it to 2-3 times, but she was still getting chest tightness, hacky cough. It was kind of like nausea- it was hard to explain, it was kind of like a chest nausea, which she had also had back in Jan2020 when she had the bad flu. She also would get this laryngitis and had trouble talking. With her flare-up, her chest tightness/nausea feeling in the chest continued. Now, she was getting into laryngitis type of thing, but she could loosen that up with her duoneb but if she got to the point where she could not do that, she would definitely have to see someone right away. She clarified that when her chest got tight, the dry, hacky cough continued/increased. When she did the breathing treatment, it loosened it up for about 3-4 hours and some of the pain would go away in her chest. If she talked too much, she would begin to cough. She had had this flare up 3 times in her life, it was not very common. She was diagnosed with asthma in her 40s, and this was her 3rd time ever having anything like this. This was the first time she had experienced a flare up like this. She had had 3 episodes since she had had asthma in her 40's and all 3 bad episodes were about the same. All the episodes were related to illness, it did not just happen out of the blue. It happened with a viral respiratory thing or the flu. The adverse events did not require a visit to the emergency room or physician office. The patient stated that she would call her physician or the clinic "today or tomorrow". She had not been to a doctor since her asthma flared up. Her respiratory doctor/pulmonologist moved away, there was no respiratory doctor nearby right now. So, her general practitioner was following her because it was a mild case and she had mild asthma. If it was severe, her doctor would make her go to a specialist. Relevant tests were reported as no. The patient used to be followed with pulmonary function tests until her respiratory doctor moved away. The patient stated that she took care of her 94 year old mother several days a week and because of all of the variances coming out, she thought it was her civic duty to prevent it from spreading through the population and creating more variances which was why she received the vaccine. She stated her doses were scheduled a month apart because they expecting to get a shipment of Moderna and they did not. They had to run to Buffalo to get the Pfizer vaccine, but they left her doses scheduled a month apart because the appointments were so hard to get. Normally, it would be 3 weeks. Her card clearly said Pfizer and they told her Pfizer, and they told her the reason for it being scheduled at 4 weeks. The patient called to inquire whether asthma flare-ups had been seen in clinical trials. It was not a reported side effect from the paperwork she received. When she looked online, she could not really find anything. She was thinking of going to a clinic but was wondering if there were any reports of flare-ups with asthma with the vaccine. With regards to causality, the patient stated it was a concern because she usually did not get a flare-up unless she was sick. She stated that there were many variables, and that it was spring, and bugs were out, but she did not usually get a flare-up like this. She stated that maybe it was a challenge to her immune system, the antibodies, but she did not know. She suspected the flare-up was related to the vaccine, but she did not have any idea. She would say yes, but she had no way of knowing. The flare-up usually only appeared if she got ill or something weird happened to her. The clinical outcomes of the events flu-like symptoms, fever, achy and fatigue were recovered/resolved on 27Mar2021; sore arm and headache were recovered/resolved on 28Mar2021; asthma flare up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were not recovered/not resolved; she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia were unknown. The reporter believed there was a reasonable possibility that the events sore arm, flu-like symptoms, asthma flare-up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were related to BNT162B2. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the events asthma flare-ups and viral pneumonia are attributed to intercurrent medical conditions, unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-04-30 | facial paralysis, numbness |
Bell's palsy/Facial droop; facial numbness; This is a spontaneous report from a contactable other he...
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Bell's palsy/Facial droop; facial numbness; This is a spontaneous report from a contactable other health care professional. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 04Mar2021 (at the age of 68-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, Blood pressure, cholesterol. Concomitant medications included insulin glargine (LANTUS) taken for diabetes mellitus; insulin lispro (HUMALOG) taken for diabetes mellitus; amlodipine besilate (NORVASC) taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol; start and stop dates were not reported. On 22Mar2021, the patient experienced Bell's palsy/facial droop, and facial numbness. The outcome of the events was not recovered. The patient received treatment for the events: Nurse Practitioner stated, "She was given by the emergency room. She was treated with Prednisone. 20mg, tablet, 3 tablet one time in a day, oral. Bell's palsy. She was also given Valtrex. 1gm, oral, tablet, 3 times a day." Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of bnt162b2 to the development of Bell's palsy/facial droop cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-04-30 | pain in extremity |
confused/When talking to her she is talking out of her head/hought her condo was turned completely a...
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confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-30 | pain in extremity |
headache; soreness to the arm; Too late to get the second dose; This is a spontaneous report from a ...
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headache; soreness to the arm; Too late to get the second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration on 11Jan2021 (at the age of 68-years old) at a single dose for COVID-19 immunization. Medical history included respiratory disorder from Dec2020 and ongoing. Concomitant medications were not reported. The patient received the first dose and stated that she only had a headache and soreness to the arm on an unspecified date. The patient was at the ENT being checked for a respiratory infection when she was contacted to make her second dose appointment. She had the respiratory problem since December and had made the appointment for the ENT prior to the first dose of the vaccine. She confirmed that she was not diagnosed with a respiratory infection. She was told to reschedule her second dose appointment which was originally scheduled for 01Feb2021, but she asked the pharmacy and was told that it was too late to get the second dose. She wanted to know if she can get the second dose after six weeks. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-04-30 | weakness |
today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is ir...
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today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 68 | 2021-05-03 | weakness, pain in extremity |
fever; fatigued; Did not have much energy/having no energy/low energy; Left Arm was painful and it g...
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fever; fatigued; Did not have much energy/having no energy/low energy; Left Arm was painful and it got swollen a bit; Left arm painful; Foggy and not clear; extreme shortness of breath/cannot catch her breath; almost hyperventilating/Hyperventilation; This is a spontaneous report from two contactable consumers (including husband and patient self) and patient self. A 68-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204) at single dose on 20Mar2021 14:54 injected in left arm in the muscle for Covid-19 immunization. Medical history included shortness of breath, hypothyroidism and COVID-19 back in Dec2020. She had some food allergies that were diagnosed prior to getting the vaccine. Patient was tested positive for COVID on 21Dec2020 and negative on 20Jan2021. The symptoms followed for patient was a little coughing and no smell for 3 days and a little shortness of breath. Family medical history was none. Concomitant drug included levothyroxine 0.75 ug, once daily for hypothyroidism, which was taking for 15 years (as of 19Apr2021). No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. Patient experienced left arm painful on 20Mar2021 about an hour or two after she got the injection, did not have much energy on 21Mar2021 08:00, foggy and not clear from 21Mar2021 to 22Mar2021 08:00, shortness of breath started 24Mar2021 or 25Mar2021, and hyperventilation on an unknown date in Mar2021 (reported as a week or 9 days after receiving vaccine). The shortness of breath was what she referred to as hyperventilating. That came a week after the vaccine. The same date they took shot was when the arm pain started and the low energy was the day after. Foggy and not being clear was from 21Mar2021 to 22Mar2021. Shortness of breath started 24Mar2021 or 25Mar2021. In additional to shortness of breath, she had been hyperventilating. That began approximately a week or 9 days after receiving vaccine. Left arm was painful and it got swollen a bit and lasted for 48 hours. The husband experienced arm pain and said he almost had a fever and felt fatigued. The reporter thinks patient (his wife) felt the same. She had arm pain and not much energy. They came out of that ok. About a week after the first injection, she just cannot catch her breath. She started hyperventilating to the point where the husband thought she would expire. She also experienced being foggy and not clear and having no energy. First, she went to a Cardiologist and he said there was nothing wrong. She then saw a lung doctor who send for respiratory chest and did chest CT scans and everything was clear on both test. He did not prescribe any medications. A week after she saw him, she went to the ER on 31Mar2021for hyperventilation and shortness of breath. They prescribed Xanax (AER 2021434900). She said it did not work and they prescribed something else. It was 25 mg twice a day which was in a pharmacy vial. They then prescribed Lorazepam. She was afraid to take it. She took one instead of two. The dose was 0.25 mg twice daily. The ER did CT scan of chest with Contrast. It was negative for thromboembolism (also reported as CAT scan's negative for blood clots). She had shortness of breath before the vaccination and it got worse. She was managing it though. Outcome of left arm painful, foggy and not clear, did not have much energy/having no energy/low energy was resolving. Outcome of shortness of breath and hyperventilation was not resolved. Outcome of the other events was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-05-03 | tremor |
throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a...
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throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a spontaneous report from a contactable consumer. This 68-years-old Female consumer reported herself that: Country: Report about covid vaccine: Yes. Reporting type: AE. Reporter type: Non-healthcare Professional reporting for a patient. Patient name: (name). DOB: ## Age group: Elderly (65+ Years). Current age: 68. Current age unit: Years. Gender: Female. Is pregnant: No. Race: (race). Address street: (address). City: (city). State: (state). Zipcode: ### Phone no.: ## Email: (mail id). Covid vaccine details: Product=COVID 19 Brand=Prizer. Lot number= EN6198. Lot unknown= False Administration date=03Mar2021 Administration time=10:15 AM Vaccine location= Right arm. Dose number=1 Facility type vaccine: (name) Facility name: (name) Facility address street: (address) Facility city: (city) Facility state: (state) Facility zipcode: ### Facility country: If other vaccine in four weeks: No. Other medications in two weeks: Albuterol Inhaler. Adverse event: I had a throbbing headache in the back of my head that has lasted 12 days. It was the worst headache I have ever had and had terrible fatigue. My hands had tremors and I had body aches for 3 days. Headache so bad I had to get a CT scan Adverse event start date: 05Mar2021 Adverse event start time: 12:00 AM Adverse event country: Ae resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Recovering If treatment ae: Yes. Ae treatment: CT scan, Blood work. If covid prior vaccination: No. If Covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab Covid test name post vaccination=Rapid Test Covid test date=12Mar2021 Covid test result=Negative. Known allergies: No. Other medical history: Cancer in remission for 6 years. Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Patient Details: Initials: (name). Sex: Female. Is the patient also the reporter? Yes Date of birth: ### Country of Incidence: Reporter Details: Reporter type: Consumer or other non health professional. Reporter type details: self. First name: (name). Surname: (name). Address line: (address). Town / City: (city). County / State: (state). Post code / ZIP code: ## Country: Telephone: ## Email address: (mail). Primary / Prescribing Healthcare Professional Info: Country: Event Details: Company aware date: 23Mar2021 Report type: Follow-up Report no new event Products: Suspect products: COVID Vaccine: NDC number: Not Provided. Lot Number: Not Provided. Reason for no lot number: Other: follow up report and she previously provided it. Expiry date: Not Provided. History: Concomitant Products: Other Products Not Provided. Other conditions: Other Conditions Not Provided. Investigations: Investigations Not Provided. Additional Context: Other Reference(s): No Transfer to agency Required. Additional Context: She had her first shot three weeks ago tomorrow. She is scheduled to get second one tomorrow. She was sick for 13 days after the first one. She was so sick. The headache was so bad the doctor sent her for a CT scan of her head. The headache was at the crown of the head and down into the back of the head. She never had a headache in the back of her head like that before. Her doctor wanted to make sure no bleed. It started lightly for two days and got worse and worse. It was 13 days before it went away. On top of that she had muscle aches in the beginning, but those went away. She was exhausted. She has already sent this in to Pfizer. She is questioning if she should get the second dose. She did get a COVID test and that was negative. She has done what she was supposed to do. Reference Number: she doesn't have a reference number. She has been on hold for two hours. She held because she feels this is very important. She really don't want to end up in trouble because she gets the second vaccine. Her doctor said it is a tough call. When she has to go get a shot and walk in with an EpiPen it gives her an ugly feeling. Her doctor is really not thrilled. She is darned if she does and darned if she doesn't. She knows one lady that died two days later and another one that died a couple of days later. They were both in another place. One was the wife of a surgeon. She thinks it has been reported. One was a community leader. They are waiting on the autopsies. Caller declined to proceed with a report for the two women that died after receiving the COVID vaccine. One died in the bathroom on the second day. The other is a doctor's wife and she passed one to two days after the shot. Neither was expected. Caller doesn't have their health records. She doesn't live in the same town. She is sure they are aware at Pfizer that this happened. She can't find anything. She didn't get a reference number from Pfizer. She gave the lot number when she reported it before because she remembered she had to get the card. She also reported it through (name). (name) gave her a confirmation number of ## on 13Mar2021. She think she would have filed them at the same time, so she probably reported it to Pfizer on 13Mar2021. Caller is going to delay the second shot. She knows she has up to 42 days. to get it. Is there a product complaint to report: No. Is there a medical information request: Yes. Please describe the medical information request: She is questioning if she should get the second dose. Is this an Other report: No Site: Call Centre # Contact Centre Ref: ##, ## Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Primary source(s) of information: Reporter title: (title). Reporter given name: (name). Reporter family name: (name). Reporter's postcode: ### Reporter country code: Qualification: Consumer or other professional. Reporter Phone Number: ### Patient characteristics: Patient: PRIVACY. Sex: male. Patient First Name: (name). Patient Last Name: (name). Drug(s) Information: Characterization of drug role: suspect. Proprietary medicinal product name: Pfizer-Biotech COVID-19 Vaccine. Identification of the country where the drug was obtained: Country of authorization/application: Active Substance Information: Active Drug substance names: Pfizer-Biotech COVID-19 Vaccine. Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient. PQC Present: No. AE Present: Yes. PQC Details: Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Potential Duplicate case: Caller stated she reported this online to Pfizer safety on 13Mar. Caller received the first dose of the Pfizer covid vaccine on 03Mar and it made her sick for 13 days. She had a really bad headache for 9 days and had a CT scan done for the headache, she was in the hospital, was exhausted. Caller is scheduled for second dose tomorrow. caller wanted to know if the side effects lasted that long after the first dose with other people. caller is a 68 years old female. Caller stated she is not sure about if the 2 females who received the covid vaccine were Pfizer covid vaccine or not but they died in (place name). Caller refused to provide any other information including age of the patients. Caller stated that one of them was a Doctor's wife. Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Question: Caller wanted to know how many people experienced severe headache and were they given the second dose.
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| 68 | 2021-05-07 | muscle spasms |
she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting ...
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she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting hurting; she is scared; She used to weight 143 pounds 9 months ago, she states she is swelling up.; overall body aches; cramping; eyes had swollen; fever of 101.9°F/temperature like 101.9 degrees, a fever; chills; nausea; wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) as SINGLE DOSE (at the age of 68 years old) for covid-19 immunisation. Medical history included she is on the borderline of Chronic obstructive pulmonary disease (COPD). She was taking breathing medicine, but has been taken off of it, she is doing so well; osteoporosis; osteoarthritis; osteopenia. Concomitant medication included hydrocodone (HYDROCODONE) taken for osteoporosis, osteoarthritis, osteopenia, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On unspecified date the patient experienced feeling chest pain/her chest is sore, headache/her head just starting hurting, she is scared, she used to weight 143 pounds 9 months ago, she states she is swelling up and overall body aches. On 14 Apr2021, she experienced wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker. She wiped this morning, and she thinks it stopped. She felt cramping. It started light pink, then a couple days ago it was darker. She was a walk in patient at the clinic to be checked out. She lives alone, has no companion for a sex life, she had no new medications. She went to her physician yesterday 22Apr2021, and had a pap smear and blood draws. Her MD told her to take Airborne around the time of the second vaccine. On 16Apr2021 she experienced nausea. On 22Apr2021 the patient experienced eyes had swollen, fever of 101.9°F/temperature like 101.9 degrees, a fever, chills. On 23Apr2021 the patient experienced cramping.The headache has been on and off all weekend. She felt she was dying. The worst yesterday. She read all the Covid symptoms and all her symptoms point toward Covid. She feels like she has Covid from unknown date.She has chest pain and tries to ignore it, but she can't. She has to go get her pain pills because her head just starting hurting.The patient underwent lab tests and procedures which included body temperature: 101.9 degrees fahrenheit on 22Apr2021, blood test: unknown results on 22Apr2021, pap smear: unknown results on 22Apr2021, weight: 143 lbs on 9 months ago. Therapeutic measures were taken as a result of overall body aches. She took gas pain pills, allergy relief pain pills because her whole body hurt. She has been applying warm towels to her eyes to help with swelling. Outcome of fever of 101.9°F/temperature like 101.9 degrees, a fever, chills was recovered on 23Apr2021. Outcome of eyes had swollen, headache/her head just starting hurting, nausea, wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker was recovering. Outcome of feeling chest pain/her chest is sore was not recovered. Outcome of she feels like she has Covid, she is scared, cramping, he used to weight 143 pounds 9 months ago, she states she is swelling up, overall body aches were unknown.
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| 69 | 2021-01-01 | numbness, feeling hot |
Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started h...
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Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started hurting with burning sensation, pressure in both ears and slight numbness across face from ear to ear and under nose. Uncomfortable tightness in chest and a lot of pressure on face feeling like it was hot. I felt a little better after 15 minutes while waiting but never told anyone about symptoms. I walked out and drove home but monitored my symptoms. The symptoms gradually became less and were gone after 1 hour and 45 minutes. I took a dose of benadryl at that time. I slept well that night and woke up with no symptoms and none since.
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| 69 | 2021-01-03 | pain in extremity |
On 12-21-2020, after the injection patient states she did not feet well and her right index finger b...
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On 12-21-2020, after the injection patient states she did not feet well and her right index finger began to hurt right after. She states the right index finger pain started to hurt also on 12-23-2020. She states she will be receiving her second dose on Thursday 01-07-2021.
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| 69 | 2021-01-04 | numbness |
Numbness from Neck to face to head on the left side. Lasted a few days. 12-30-2020 to January 3rd, ...
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Numbness from Neck to face to head on the left side. Lasted a few days. 12-30-2020 to January 3rd, 2021.
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| 69 | 2021-01-05 | pain in extremity |
Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the...
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Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness. Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued. All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely. I had chills/sweats all through the afternoon and into the evening. I did not even get out out bed until the next afternoon (1-1-21). For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.
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| 69 | 2021-01-06 | numbness |
Vaccine recipient complained of "some left-sided numbness in her ears and arms" almost immediately. ...
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Vaccine recipient complained of "some left-sided numbness in her ears and arms" almost immediately. Report received second-hand from the vaccine clinic director.
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| 69 | 2021-01-11 | weakness |
Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patien...
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Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 10:00 at single dose in her left arm for covid-19 immunization. The patient medical history was not reported. The patient concomitant that the patient received within 2 weeks of vaccination included "blood pressure" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced light headed, weakness, body aches on 05Jan2021 10:00. No treatment received for the adverse event. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
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| 69 | 2021-01-13 | pain in extremity |
Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthc...
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Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthcare professional (reported for herself). This 69- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK423), via an unspecified route of administration, on 05Jan2021 at 10:30 AM (at the age of 69-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. The patient does not have any medical history. The patient was not taking any concomitant medications. The patient did not receive any medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jan2021 at 04:00 AM, she experienced a sore arm and an increase in temperature. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and an increase in temperature was recovered. Patient was not tested for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-01-14 | pain in extremity |
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa...
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experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-01-15 | tingling |
Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 min...
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Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 minutes. The patient returned to the observation area after 1:30 pm complaining of symptom onset at approximately 1:35 pm of "wooziness", faster heart beat, and legs tingling. She did not want medical help but stayed for an hour of observation in which her blood pressure was taken at least twice in the normal range, sat with her legs elevated for a few minutes but not most of that time. At 2:30pm she reported not feeling any better but now reported tingling in hand and leg of her right side only. BP/hr at 2:35pm were 121/96 and 112 from a seated position and both legs on floor. The patient said she would touch base with her physician who is unnamed. She was also given information and encouraged to fill a report herself with VAERS.
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| 69 | 2021-01-16 | numbness |
Facial numbing within 10 minutes; subsided and gone within 40 minutes. Had read that bell's palsy ...
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Facial numbing within 10 minutes; subsided and gone within 40 minutes. Had read that bell's palsy was possible side effect so was not worried.
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| 69 | 2021-01-16 | pain in extremity | First day : Pain the arm and chills 2nd day : Nausea |
| 69 | 2021-01-17 | seizure |
I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sic...
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I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.
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| 69 | 2021-01-18 | tenderness |
Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, p...
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Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, painful making legs feel like 2 cement blocks to walk. Both shoulders were inflamed and muscles locked causing difficulty in mobility. Both hip joints felt irritated, the left more aggravated and painful. Also the body experienced being tired and sluggishness needing more than usual sleep. This lasting about 8 days. Treatment: ActivIce/Biofreeze spray several times daily and elevation to release pressure and blood flow.
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| 69 | 2021-01-19 | pain in extremity |
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. ...
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At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
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| 69 | 2021-01-19 | burning sensation |
Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged ...
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Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged and sticking out.
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| 69 | 2021-01-19 | weakness |
Patient advises that she had developed injection site soreness on the night of her injection. The ne...
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Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
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| 69 | 2021-01-19 | difficulty speaking |
Patient describes Soreness at injection site, later experienced body aches, headache, fever that is ...
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Patient describes Soreness at injection site, later experienced body aches, headache, fever that is rising and hoarseness in voice
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| 69 | 2021-01-20 | pain in extremity |
Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely...
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Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the left arm on 07Jan2021 at 14:00 at a single dose for COVID-19 immunisation. Medical history included HBP (hypertension). The patient was not pregnant at the time of vaccination, has not received any other vaccine within four weeks, and did not have COVID prior to the vaccination. Concomitant medication included losartan (also reported as other medication in two weeks). The patient previously took Aleve and experienced allergies. On 07Jan2021 at 02:00 PM, the patient experienced injection into left arm hurt upon injection and as the hours wore on, the arm got very sore and felt like lead-she could barely raise her arm up without assistance of the other arm. However, it dissipated within 24 hours and felt fine thereafter. The patient did not test positive for COVID post-vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 69 | 2021-01-20 | pain in extremity |
Severe 9/10 Right and left Achilles and low foot pain and pain on palpating-left greater than righ...
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Severe 9/10 Right and left Achilles and low foot pain and pain on palpating-left greater than right-not relieved with Ibuprofen. This interferes with walking due to pain.Never had pain in that location before
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| 69 | 2021-01-20 | pain in extremity |
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; musc...
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anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-01-21 | feeling hot |
Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63 oth...
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Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63 other medical conditions was reported as no. but blood sugar was 63. Patient given grape juice and sandwich repeat bs was 102 patient recovered with no further treatment.
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| 69 | 2021-01-22 | weakness |
Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extrem...
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Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extremities - started 7-10 days after injection.
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| 69 | 2021-01-23 | weakness |
I became weak and thought I was going to faint. I called the medical professional over and they brou...
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I became weak and thought I was going to faint. I called the medical professional over and they brought me into a staged area for triage. My blood pressure was 171/ 104 or 114. I had chest pain. The EMT did and EKG, listened to my heart, and started an IV. The ambulance was called and I was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. I was admitted to the hospital due to elevation of tyoponin level and chest pain. The following day 1/22/21 I saw my PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of tyoponin and chest pain. The cardiologist performed another EKG< more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that I was given a nitro pill as my chest pain was between a 7 and a 8; a few minutes later the nurse asked about my pain level and it was a 3-4. I was given another nitro pill and shortly after I felt extremely faint and my blood pressure was 56/32. I was immediately given a bolus of saline IV . The chest pain continued through the day. The following day, I had no further chest pain, my tyoponin levels returned to normal and I was released from the hospital.
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| 69 | 2021-01-24 | tremor |
Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with unc...
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Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with uncontrollable shaking
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| 69 | 2021-01-25 | night sweats, weakness |
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom...
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2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
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| 69 | 2021-01-25 | pain in extremity, breast pain |
Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side...
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Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side just behind the injection site. By Sunday afternoon the pain became debilitating and the pain spread to my underarm and the edge of the breast area. I applied heat and rested. The sharp pain interfered with sleep and regular life activities. On Tuesday morning I applied an ice pack, which relieved the pain. After applying ice for two more times, the pain subsided and the swelling under my arm disappeared. I was able to resume normal activities with slight discomfort.
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| 69 | 2021-01-25 | night sweats |
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f...
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sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
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| 69 | 2021-01-26 | night sweats |
Extreme night sweats to the point of wrenching bidding. Would occur they the nite waking me. Never h...
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Extreme night sweats to the point of wrenching bidding. Would occur they the nite waking me. Never had this before.
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| 69 | 2021-01-26 | pain in extremity | Severe pain in right arm. Very little range of motion. Shoulder joint very painful. |
| 69 | 2021-01-26 | pain in extremity |
She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was s...
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She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was sent to ER for evaluation of leg weakness.
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| 69 | 2021-01-26 | pain in extremity |
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headac...
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first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache. Today, forth day, swelling going down still red, no headache and feeling better in general. Took tylenol for headache and pain.
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| 69 | 2021-01-27 | pain in extremity |
1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness ...
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1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness 2nd night- fever over 100 degrees, major chills and shivering, joint stiffness, no headache 3rd night- no fever but MAJOR sweating, sweating, sweating. No headache, stiffness much improved. 4th day - all symptoms almost gone, no headache, stiffness improved. Arm still sore
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| 69 | 2021-01-27 | pain in extremity | Mild arm soreness. |
| 69 | 2021-01-27 | numbness |
blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizzin...
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blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
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| 69 | 2021-01-28 | pain in extremity |
When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started i...
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When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started irritating a little bit. So then i left it alone because I didn't now if that was part of a reaction. When i got home i still had the odor in my mouth. i drank cold water and it went away. I waited. I felt sore on my arm but it wasn't that bad but as the hours went on it started getting more sore and painful. My arm was sore up to my shoulder and the back. After that the pain started traveling towards to my chest and i started getting pain in my chest. i took Tylenol (1 500 mg extra strength at 11:15 PM). So i waited 15 minutes to go to sleep. i got up the next day and everything was the same, i started putting ice on it and gave it time. I took another Tylenol but the pain was in my chest again a little bit. The third day the pain didn't come back in my chest and from then i was alright. I also started getting an itch.
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| 69 | 2021-01-28 | weakness, involuntary muscle movements |
temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off;...
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temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
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| 69 | 2021-01-29 | discomfort |
2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of fore...
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2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of forehead and radiating toward my left eye. MD stated it was too coincidental not to be related to vaccine. I had NO s/s of illness prior to injection. MD would not allow me to take 2nd dose.
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| 69 | 2021-01-29 | tingling, pain in extremity |
Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away withi...
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Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away within 30 minutes. But 2-3 hours later three fingers had peeling. Also wrinkly fingers. Increased water and added electrolytes. Notified doctor, who instructed to elevate and ice arm, and to start benadryl. Also take benadryl before next vaccine. Left arm may still be slightly swollen, but most swelling gone by 12 hours. Sore arm for a couple days, intermittent headache which took tylenol for. Fatigue, still.
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| 69 | 2021-01-29 | pain in extremity | sore arm, headache that night, nausea the following day. |
| 69 | 2021-01-30 | weakness |
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin,...
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Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
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| 69 | 2021-01-30 | pain in extremity | Flu symptoms: chills, diarrhea , headache, sore left arm (injection site) |
| 69 | 2021-01-30 | feeling cold |
Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent p...
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Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent periods of chills - but much less severe. Also had a temp of 100,2 w/ slight headache. Started taking tylenol about 3 am on the 30th.; then every 6 hours after. Did stay in bed - slept basically until 9am - this date 1/31/21. Although I think this was a "normal" reaction - just thought I should report it - to add to generally data about the vaccine.
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| 69 | 2021-01-31 | pain in extremity |
Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a ...
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Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a little bit more; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), intramuscular in the right upper arm on 15Jan2021 at 12:30 (at the age of 69-years-old) as a 0.3 ml single dose for COVID-19 immunization. Medical history included atrial septal defect, palpitations, and COVID-19 from Aug2020 to an unknown date. The patient had COVID antibody titers done in Aug2020 and Dec2020 and they were "270." Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), cyanocobalamin (B12-VITAMIIN), estrogens conjugated (PREMARIN), pravastatin (MANUFACTURER UNKNOWN), and escitalopram oxalate (LEXAPRO). On 15Jan2021 after getting the vaccine, the patient had a sore arm but it was mild. Then as the night went on, it started to hurt a little bit more. On 16Jan2021, the patient had flu like body aches, and had a temperature of 100. The patient did not receive any treatment for the events. The clinical outcome of the sore arm that hurt a little bit more was not recovered; while that of the flu like body aches and a temperature of 100, were unknown. The nurse thought the events were related to the vaccination.
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| 69 | 2021-02-01 | pain in extremity |
I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot ...
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I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot that high up. She said in a snide voice it?s still the deltoid and she shot my bursa. The evening of the shot I started having severe arm pain and nausea. The next morning I had right scapula rib pain it was hard to breathe my arm hurt very bad I can hardly lift it I went to work. When I got to work I couldn?t function I was so nauseated with the pain I went home that day and I?ve missed three days total from that event of wrong injection site. The pain has gotten worse I can?t lift my arm left right upper down without pain and it?s going into my neck and down to my elbow now I went to the occupational medical doctor. I told him what happened and he said she gave me the shot am I supraspinatus Bursa and I have an injury to my bursa. I came back for a second visit the next week and he said I have bursitis from that now I can?t raise and use my arm that well at all and I have severe pain 24 seven still and he sent me to a physical therapist starting today 2 to 21. It has gotten worse and my shoulder has locked up three times. I still have ongoing pain 24 seven and I want to report a complaint against the girl who gave my shot I thought she was an LPN but she is a MA. We both work at healthcare clinic. I am a 26 year RN and she did not listen to me and she stuck me anyway against my will.
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| 69 | 2021-02-01 | pain in extremity |
Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. R...
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Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. Resolved with no intervention. Fatigue from 01/12/2021 through 01/21/2021. Severity on 1-10 scale = 7. Resolved with rest. No residual. Received 2nd dose on 02/01/2021 in right deltoid at 1:22 pm. Temp on day of dosing was 97 degrees - normal for me. 02/02/2021 AM right arm soreness, achy all over, and chilled. By 1 PM temp was 100.1. Took 500 mg of Acetaminophen, fLuis?s and rest
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| 69 | 2021-02-01 | feeling hot |
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration in Jan2021 (on Thursday) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller received the first dose of the vaccine on Thursday in Jan2021 and she's felling bad, she couldn't go to work and would like to know what she could do. Had been down ever since. Couldn't get out of bed. Has a temperature. Felt so bad she couldn't go into work today (18Jan2021). Not sure what's going on. Clarified she's referring to the Pfizer COVID-19 Vaccine. Had she known what she knows now she would not have taken it. The patient was hot, sweating, and dizzy. (Facility name) administered the COVID-19 Vaccine. Didn't know if she needs to go get tested. Felt like crap. Felt bad. Hasn't been out of bed in three days. Requested to be transferred. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 69 | 2021-02-02 | tremor |
States had vaccin 1/22/21, did okay initially, felt thirsty , drank coffee afterwards and felt bette...
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States had vaccin 1/22/21, did okay initially, felt thirsty , drank coffee afterwards and felt better, went home after, had some "shimmery vision - like things see brighter which is slightly better, also felt body buzzing - which resolved, hands are shaky which is persisting (as of 1/25/21) ; no thrt closing or resp sx,
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| 69 | 2021-02-03 | feeling hot, flushing |
Dizziness c/o feeling warm and flushed. Felt dizzy while getting into recliner. monitor 15 min. Reso...
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Dizziness c/o feeling warm and flushed. Felt dizzy while getting into recliner. monitor 15 min. Resolved. Narrative: 2nd dose given. C/o feeling warm and flushed. 183/73, 63, O2sat 100%. Felt "dizzy" when transferring to the recliner. no loc. VS monitored: 159/71, 60; After 15 min: 138/64, 60 and asymptomatic and no c/o
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| 69 | 2021-02-03 | pain in extremity | Fast heartbeat, dizziness, sore arm, trouble lifting and pain, still have problem 2 weeks later |
| 69 | 2021-02-03 | difficulty speaking |
The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She ...
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The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She received her first dose of Pfizer-BioNTech COVID-19 vaccine at approximately 15:07 hrs. Due to her history of allergic reactions to multiple medications (including sulfa antibiotics and ceftriaxone), she was advised to extend her monitoring period to at least 30 minutes post-injection. At around 15:50 hrs I was notified that the patient was feeling a tingling sensation in her throat, itching, and a change in her voice. She was transferred to a stretcher for acute management of suspected anaphylaxis. Airway, breathing, circulation, and mentation were assessed immediately. EMS was called immediately via 911. Her vital signs were obtained, with a BP 168/90 mm/Hg, HR 105/min, RR 24/min. She reported shortness of breath at the time. There was no stridor or wheezing on exam. She appeared in mild respiratory distress. At 15:54 hrs she was given an intramuscular EpiPen injection (0.3 mg autoinjector) in her left thigh. At 15:58 she was given an intramuscular methylprednisolone injection (125 mg) in her right thigh. Immediately after that EMS team arrived and took over her care with plans to administer diphenhydramine intramuscularly, and will transfer to ED for further management. Throughout the event the patient remained awake, alert, and fully oriented.
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| 69 | 2021-02-03 | cold sweat |
Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopa...
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Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopal episode. EMS reported the patient's blood pressure being 70/40 mmHg. EMS administered IV saline and transported patient to emergency department. In the emergency department, patient stabilized and was discharged shortly after.
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| 69 | 2021-02-04 | tingling |
I had the sensations of facial tingling; eye swelling; lip swelling; This is a spontaneous report fr...
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I had the sensations of facial tingling; eye swelling; lip swelling; This is a spontaneous report from a contactable Nurse. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on the right arm on 20Jan2021 08:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa and allergy to animal (cats) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021 08:45 AM, the patient stated, "I had no symptoms during the 15 minute observation after the vaccine. After leaving the site, about 30 minutes after the shot I had the sensations of facial tingling, eye swelling and lip swelling (nothing visible on a photograph). My pulse remained stable and I had no throat symptoms or trouble breathing. This all resolved spontaneously within an hour after the shot. I am allergic to cats and sulfa but have never had anaphylaxis. I plan to stay in observation for a little longer after the 2nd shot. Any other recommendations?" No treatment was received for the events. The outcome of the events was recovered on 20Jan2021.
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| 69 | 2021-02-04 | numbness |
Within 5 minutes there was extreme anxiety followed by swelling of finger, face and feet, , loss of ...
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Within 5 minutes there was extreme anxiety followed by swelling of finger, face and feet, , loss of voice, swelling of throat, Treated with Benadryl, oral steroids, with some improvement over 30 minutes Then worsened with increased throat swelling, numbness of feet. Taken to ER above, treated with Epi injection, Iv solumedrol and pepcid with improvement Sent home after 3-4 hours, Next morning 12 hours after leaving Er Voice better but began to worsen another dose of oral prednisone, benedryl andPepcid taken with improvement
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| 69 | 2021-02-04 | feeling cold | slight headache, slight, nausea, chilling |
| 69 | 2021-02-05 | flushing |
I received my first COVID19 at around 5:00 p.m. at Walgreens. I was asked to remain in the store f...
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I received my first COVID19 at around 5:00 p.m. at Walgreens. I was asked to remain in the store for 15 minutes. By the time I got home, at around 5:25 p.m., I was feeling woozy, my neck was red (flushed), I had a strange metallic taste in my mouth, I was very thirsty, and I felt that my throat was somewhat constricted. I immediately took a Benadryl. (I knew to do this because I had done this when I had an allergic reaction to penicillin years ago. By about an hour later I felt alright and the redness on my neck had almost faded away.
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| 69 | 2021-02-05 | flushing | after 30 mins, pt reports feeling "flushed" |
| 69 | 2021-02-06 | pain in extremity, migraine |
Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2...
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Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2 Tylenol 500mg each, had bad headache for rest of the day. Left arm pain that radiated into left shoulder and neck area, applied heat. Was awakened very early 2nd morning with headache, causing me to get up as hurt to lay head on pillow. Took 2 Tylenol, so far only slight decrease in pain.
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| 69 | 2021-02-06 | pain in extremity |
Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to...
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Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to my shoulder. By the next day, it was really painful in my shoulder and across my back almost to my backbone. It was painful to move my arm up or down or to reach for things. This lasted 3 to 4 days. Then my neck on the same side as the shot (left) began to hurt so badly I couldn't move my neck up or down or sideways. It was strange the way the pain slowly moved across by arm to my shoulder to my back and up my neck. I've never experienced anything like this before. Today my pain in my neck is bearable but I have soreness and a headache. I hope I am at the end of the cycle to this event as I am scheduled for my next shot soon.
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| 69 | 2021-02-07 | breast pain |
1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt ...
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1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt went to PCP and was diagnosed with Shingles.
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| 69 | 2021-02-07 | pain in extremity | Arm is very sore and itchy. Headache, fatigue, restless. Just did not feel well. Lasted one day. |
| 69 | 2021-02-07 | burning sensation, tenderness |
Just had the shot, waited 20 minutes and left and then went to get groceries and started itching in ...
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Just had the shot, waited 20 minutes and left and then went to get groceries and started itching in my neck first and went down underneath my breasts, stomach, and arms around 3:30, 4:00 o'clock. Saturday evening burning and itching is really bad. Put some topical creams on it. Next day itching was less bad but I was sore and tender. Today the itching isn't as bad, but its hot to the touch.
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| 69 | 2021-02-08 | feeling jittery |
Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitte...
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Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitteriness, and elevated blood pressure. She was monitored for several minutes and started feeling better. She admits to being nervous to take the vaccine and has had several episodes like this before after vaccines. She was steady enough to drive herself home and she went to bed for a few hours and woke up feeling fine except for a sore arm for 2-3 days. Had physical 3 days after this episode and he said she was fine.
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| 69 | 2021-02-08 | tremor | Chills/Shaking, 102 fever, swollen lymph nodes under chin, nausea, tiredness |
| 69 | 2021-02-08 | tingling |
The vaccine recipient complained of itching and tingling around the mouth, face, and nose . Per ...
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The vaccine recipient complained of itching and tingling around the mouth, face, and nose . Per Dr. recommendation, pt. received 50 mgs of PO Benadryl. Three set of vital signs were taken. Water was provided . Vaccine recipient was taken home by her husband via wheelchair . Initial vitals at 11:38: BP : 144/104, pule 72, RR: 20, O2 98%. 11:40: O2 99%, pulse: 72 1145: 99%, pulse: 68 1147: BP: 130/80, pulse: 68, 99%. 1200: BP: 130/65, O2 99%, pulse: 65, RR: 18 1205: pt. denied any further symptom/itching. Pt. was released to her husband via wheelchair.
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| 69 | 2021-02-09 | muscle twitching |
I am not sure if this is related to vaccine or not. On Feb 5 one side of my face was drawn up for a...
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I am not sure if this is related to vaccine or not. On Feb 5 one side of my face was drawn up for about a minute, like a muscle spasm. Since that time that side of my face twitches when I smile. It is on my right side between my lip and my eye.
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| 69 | 2021-02-09 | pain in extremity |
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.;...
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Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.
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| 69 | 2021-02-09 | migraine |
Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (...
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Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 14:30 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to sulfa drugs. Concomitant medications included escitalopram, alprazolam, paracetamol (TYLENOL), simethicone (GAS X), and vitamin D. The patient previously took aspirin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. On 12Jan2021, at 14:30, the patient experienced soreness at shot site, fatigue, and migraine. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.
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| 69 | 2021-02-10 | discomfort, migraine |
Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength ...
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Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength headaches, ripping pain in chest, ribs, upper back, shoulders, neck, head. I could not sit or lie down comfortably. I saw Dr. on February 1 who ordered a CT scan which was clear. He prescribed Prednisone and Robaxin 500 mg. I saw Dr. again on February 4 at which time most of the pain subsided but my body was very sore. It is now February 11 and I still feel a bit of cloudiness, but am much better. Hopefully, I'll feel like myself within a few days.
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| 69 | 2021-02-10 | pain in extremity |
Recovered from covid-19 December 2020. Mild case with antibodies but all covid tests were negative ...
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Recovered from covid-19 December 2020. Mild case with antibodies but all covid tests were negative After vaccine Arm soreness Fever above 102 Severe body aches Fatigue Headache
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| 69 | 2021-02-10 | feeling cold |
Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; co...
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Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
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| 69 | 2021-02-10 | numbness, tremor, muscle twitching, weakness |
Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Ment...
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Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Mentally spaced-out, weak and unable to drive my car even a few yards. Requested ambulance and was taken to emergency room. EMT administered Intravenous Benadryl. In hospital Pepcid was administered immediately. The numbness eventually spread throughout my body and I felt twitching/trembling, particularly my mouth and jaw. My feet felt like they were being pulled away from my body. After testing was complete, Solu-Medrol was administered and all symptoms disappeared immediately.
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| 69 | 2021-02-10 | weakness |
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache...
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deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
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| 69 | 2021-02-11 | cold sweat |
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he...
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Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
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| 69 | 2021-02-11 | pain in extremity |
approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like ha...
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approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like hamstrings were "pulled" and shins and ankles in pain as well. In addition, overall body fatigue, feeling exhausted. All symptoms continued for approx 36 hours, gradually ending after 48 hours
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| 69 | 2021-02-14 | cold extremities |
5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the c...
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5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the couch - socks, boots, leggings, sweatshirt, 2 blankets - and napped. 9:00pm; finally felt warm. Back and shoulder muscles were very sore. Temp had risen to 100.3F. Took 400mg ibuprofen and went to bed. Awoke the next morning feeling great. No residual effects.
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| 69 | 2021-02-14 | burning sensation, flushing |
Flushing of face chest and arms with burning sensation. Resolved an hour after receiving an antihis...
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Flushing of face chest and arms with burning sensation. Resolved an hour after receiving an antihistamine(Zyrtec)
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| 69 | 2021-02-14 | tingling |
Patient reported tingling of her right hand right after she got her vaccine. Patient stated that th...
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Patient reported tingling of her right hand right after she got her vaccine. Patient stated that the same happened when she got the first dose. At 94:43 am she stated she is feeling better and tingling is going away. She wants to go home. At 9:47 am patient stated she is going home, she is feeling ok now.
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| 69 | 2021-02-14 | weakness | Sluggish quizzing weakness slight temp |
| 69 | 2021-02-15 | cold extremities, feeling cold |
HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HY...
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HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER
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| 69 | 2021-02-16 | feeling hot |
69 yo female reports AE after receipt of Covid vaccine #1 (EN 5318 13 FEB 21) via drive thru event. ...
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69 yo female reports AE after receipt of Covid vaccine #1 (EN 5318 13 FEB 21) via drive thru event. She reports within minutes she felt unwell but had difficulty being more specific. She states she felt a warmth in her chest which traveled to her stomach. A few minutes later she felt SOB, and could not catch her breath. She states her respiratory rate increased. She talked to staff and was told if got worse to honk horn or use flashers. She did not request additional assessment. She waited her required 15 minutes and drove home another 20-25 minutes. She states she noted her face swelling. She thinks she may have had some throat swelling, but then wasn't sure. She developed some nausea, but no emesis which continued for 2-3 days. She denied watery or red eyes, runny nose, pruritis, rash, palpitations, heart racing, chest pain, cough wheezing. She states the breathing symptoms resolved in a few hours. She was unsure of the facial swelling resolution time frame. She developed a headache and felt malaise for 2-3 days, then symptoms resolved. She never took any medications other than her prescriptions. She did not seek care during symptom time frame.
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| 69 | 2021-02-16 | pain in extremity, muscle spasms |
I had reactions after the first shot of Pfizer-BioNTech on 01/27/2021, but did not think it was rela...
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I had reactions after the first shot of Pfizer-BioNTech on 01/27/2021, but did not think it was related to the vaccine. I felt pulsing and throbbing in my legs- but I thought it was related to my arthritis. I had COVID from March 14, 2020 through April 20th, 2020. I tested positive for antibodies on June 23rd, 2020. I had gotten a steroid shot in my right knee 12/10/2020 because I experienced some inflammation- the result of this was positive- I moved around easily through 12/25/2020 into the New year of 2021 and most of January. On January 27, 2021, I received my first Covid vaccine. A day later I had unusual inflammation of my right knee- I could hardly bend it. I walk down & up 80 steps everyday total (160)
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| 69 | 2021-02-16 | weakness, nerve pain |
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn...
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Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
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| 69 | 2021-02-17 | pain in extremity |
Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache;...
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Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9263 and expiry date unknown) on 26Jan2021 18:00 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included Lupus, Lyme disease, hypothyroid, Meniere's, and sulfa allergies. The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included levothyroxine (LEVOTHYROXINE), acyclovir (ACYCLOVIR), ezetimibe (EZETIMIBE), hydroxychloroquine (HYDROXYCHLOROQUINE). No other vaccine received in four weeks. The patient experienced adverse events from 20:00 on 26Jan2021. She experienced sore arm, radiated to shoulder, then to back toward backbone, then up back and side of neck. It's very painful. On 07Feb2021 ("today"), her neck pain was better but she had a headache. These events took place ongoing for several days after and since she had the vaccine. It was reported that the events resulted in Disability or permanent damage. The patient did not receive treatment for the events. The outcome of the events was provided as recovering.
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| 69 | 2021-02-17 | pain in extremity |
This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration at Right Arm on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced right arm pain on 28Jan2021. The date of her second schedule dose on 17Feb2021. The outcome was recovered on 28Jan2021.
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| 69 | 2021-02-18 | burning sensation |
severe skin rash on buttocks area, burning sensation, developed about 36 h ours after first doze of ...
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severe skin rash on buttocks area, burning sensation, developed about 36 h ours after first doze of vaccination, lasted 5 days, treated with mupirocin oitment
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| 69 | 2021-02-21 | pain in extremity |
A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was...
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A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was extremely achy. It was still happening as of Saturday, I also felt lightheaded. I felt like a was on a merry-go-round, it felt like it kept getting faster and faster. I felt dizzy all day Saturday. I had to rest all day. I lost my appetite. Anytime I got up to go to the bathroom, I had to hold something to walk. I also had a mild headache. I felt better on Sunday. My arm was still a little sore as of yesterday but it is better today.
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| 69 | 2021-02-21 | burning sensation |
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ...
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After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
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| 69 | 2021-02-21 | pain in extremity | Chills, body aches, fever, sore arm |
| 69 | 2021-02-21 | hot flush |
I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 5...
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I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 50. However, it isn't on the list of side effects but I've had hot flashes every few hours since about and 2 hours after my first dose injection. For the most part they are mild but come on every 1 to 4 hours while I'm awake. I had a terrible one like I'd never had before where I was soaked through my clothes almost exactly 24 hours after the shot the following day. They are still occurring now 72 hours after the shot. they are mostly bothersome and will hopefully subside in the next few days. Other than that I only had the normal local tenderness on my arm.
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| 69 | 2021-02-21 | unresponsive to stimuli |
Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Pa...
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Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Patient began to complain about feeling tired and wanted to take a nap later in the afternoon. Patient's husband found patient at 16:30 almost unresponsive and checked a BG reading which resulted at 25. Husband gave patient oral forms of sugar and transported to ER where he BG slowly normalized. Husband reports patient has been a well controlled diabetic and has never has an incident like this happen previously.
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| 69 | 2021-02-22 | pain in extremity | Sore arm, slight fever (100.6), fatigue, slight intestinal distress |
| 69 | 2021-02-23 | flushing |
Client states she experienced flushed face after received her vaccine. Vital signs obtained by EMS ...
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Client states she experienced flushed face after received her vaccine. Vital signs obtained by EMS BP 169/98, HR 62, O2 sat 97%. Client states she feels better. Client advised to be transported to the hosp. Client denied. Client discharged home by EMS.
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| 69 | 2021-02-23 | muscle spasms, feeling hot |
Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontane...
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Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.
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| 69 | 2021-02-23 | tingling |
Pt in tent f1 at the observation lane felt tingling chest, paramedics assessed pt. Once symptoms s...
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Pt in tent f1 at the observation lane felt tingling chest, paramedics assessed pt. Once symptoms subsided paramedics released the pt. to leave.
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| 69 | 2021-02-23 | tenderness |
She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size o...
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She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size of a dime, really sore and pink. On her way home she started having bowel issues, got home and an hour to hour and half later got explosive diarrhea, which lasted 24 hours. The spot on her arm got larger, more tender and felt warm to touch. It got to be the size of a half softball size, no swelling. Then she started having trouble breathing, could not walk as far or fast without breathing problems. She then took it easy, and the breathing issues got worse for 36 hours. On Sunday her arm was better, less sore and the diarrhea had stopped. She then stopped improving and on Tuesday 2/16/21, she was told to go to the minute clinic on 2/18/21 and when she got there her pulse rate was 40, her oxygen level was 93, and her BP was elevated. The NP there she got her oxygen level up to 94, was real raspy in her lungs. She was sent to the UC and they sent her to the ER. She was seen in the ER and isolated her, did an EKG, had a chest x-ray, gave her breathing treatments, and waited on her results, which all came back fine. They gave her 150 mg of Prednisone, another breathing treatment and within 1 1/2 hours her oxygen level was up to 97 and all of her tests were negative and they sent her home. She has now been home since last Thursday with nebulizer treatments Ipratropium bromide and Albuteral sulfate 3 times a day, rescue inhaler 4 puffs every 6 hours, Advair twice a day as well. She does have a FU with her doctor tomorrow for recheck. She feels that she is almost back to normal.
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| 69 | 2021-02-23 | feeling hot |
The itching was located just below the injection site at a spot where the skin was a little red; The...
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The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
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| 69 | 2021-02-23 | weakness | Violent chills Headache Profuse Sweating Nausea Diarrhea Light-headedness Weakness |
| 69 | 2021-02-24 | discomfort |
2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard...
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2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard Severe pain made it impossible to walk The swelling is not going down and is causing great discomfort went to the doctor yesterday and it was determined there is a blot clot
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| 69 | 2021-02-24 | tingling |
Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their ...
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Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
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| 69 | 2021-02-25 | pain in extremity, weakness |
After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, sl...
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After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, slept all day, very weak, couldn?t remember what happen rest of day after booster (2-24) or then next day during sever reaction.(2-25) Day of shot arm hurt for several hours then went away. Day 3 still listless, tired, headache, foggy.
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| 69 | 2021-02-25 | weakness |
Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very...
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Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very faint, extreme diarrhea, lasyed almost 2 hrs before being able to get up and shower off and go to bed, chills for 2 days and extremely weak. Afraid to get the 2nd shot!
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| 69 | 2021-02-25 | feeling hot, tremor, weakness |
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th...
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Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
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| 69 | 2021-02-25 | sensory loss, flushing |
Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle). Client verba...
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Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle). Client verbalized that she felt anxious and nervous about taking vaccine but started to feel decrease in sensation. Client seen by EMS and vitals are BP-168/89, Heart Rate76, O2-97. Client then cleared by EMS to go home.
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| 69 | 2021-02-25 | tremor |
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appe...
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Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
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| 69 | 2021-02-25 | feeling hot |
February 21, 2021 around 4 pm, a woman on the passenger seat of a car, driven by her husband began ...
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February 21, 2021 around 4 pm, a woman on the passenger seat of a car, driven by her husband began feeling ? dizzy?. I was approached by our CIO to see her immediately. Another Nurse came to the rescue and we both assessed the patient. She was awake, alert, oriented but anxious and stating she's dizzy. The back of the seat was lowered down for her comfort and blood pressure was taken. It was 172 /100 mmhg. PR = 72 , Temp = 97.5. RR = 18. Two other RNs came to help. The patient was conversant, her husband was upbeat and being funny. Pt started to play with her dog from the backseat reaching for it. The patient was talking but I decided to tell patient to relax since vital signs will be taken again. BP repeated after 6 minutes and its now 155/100, PR= 75, RR=19, TEMP= 97.3, 02 Sat @89 % . Pt?s hands were cold now. O2 Sat was also hard to get a good reading on all of her fingers. Called Dr. Cat Forest and she came to the scene comforting patient while vitsal signs were repeated again after 5 minutes after they were taken Now getting BP= 55/110 mmhg, PR: 80, Temp 97.2 and O2 Sat still at 89% Pt was adviced to go the ER after the Patient?s O2 Sat stayed at 89% and also after finding out that patient haven?t had any physical for two years and that patient doesnt check her blood pressure. Pt and her husband were counselled on the importance of getting regular check up especially at her age of 69 years old. Husband drove patient to the ER per order. Called patient on Monday, 2/23 and Tuesday, 2/24 with no answer. emailed patient and patient answered back and she said that she went to the ER with her husband that day and was discharged and feeling better and wanting to thank the staff for the way she was taken cared of and hoping they will be there for her second dose when she comes back.
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| 69 | 2021-02-25 | pain in extremity |
Moderate soreness in left arm. I am a physician and I have heard from many friends who are elderly t...
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Moderate soreness in left arm. I am a physician and I have heard from many friends who are elderly that they had some significant arm pain for 3-4 days after the injection. I wonder if it is because we have had 2 injections in the same place 3 weeks apart. All of them say that the first shot did not hurt. Maybe the 2 shots should be given in different locations to alleviate the pain problem. Just a suggestion. It may be beneficial to study this as well as it would decrease adverse reports.
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| 69 | 2021-02-25 | pain in extremity |
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sor...
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Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
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| 69 | 2021-02-25 | pain in extremity |
Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was ...
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Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was exhausted the next day. Aches and exhaustion subsided over 48 hours. After 2nd injection I experienced the same but milder reaction on the tenth day after the injection. However, I have been tired for a longer period of time. About 3 days.
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| 69 | 2021-02-26 | pain in extremity | ACHY ARM; JOINT PAIN; HEADACHE; FATIGUE; DIARRHEA |
| 69 | 2021-02-27 | weakness |
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the ...
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MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous, lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
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| 69 | 2021-02-27 | pain in extremity | Soar arm, fatigue, low grade fever, chills |
| 69 | 2021-02-27 | weakness |
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con...
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Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
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| 69 | 2021-02-28 | weakness |
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau...
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Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
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| 69 | 2021-02-28 | tingling, numbness |
Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feel...
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Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing; her throat started to feel like it was closing up and her tongue was really thick. She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away. She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 69 | 2021-02-28 | feeling hot |
Patient presents with vaccine reaction Had first dose Pfizer COVID vaccine and walked into waiting...
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Patient presents with vaccine reaction Had first dose Pfizer COVID vaccine and walked into waiting room for observation and started to feel like drank sometimes warm and then became dizzy shortly after that. Waited a couple minutes in waiting room and then told observer up front what she was feeling. Was asked if wanted a wheelchair to come back to examination room and patient declined and able to walk back down the hall accompanied by her husband. Denies nausea, abdominal pain, no SOB, no syncope, no recent illness, denies fevers cough, ill contacts Working wood burning project and was up till 3am and then unable to go sleep yet today. Also has stress with only child with being treated for stage 4 breast cancer Did eat breakfast around 9am- granola and cup of tea this am. Nothing since then. Current B/P 164/110 and then 10 minutes later was 150/86. Patient verbalized has history hypertension even with medication. Denies visual changes, denies headaches Vaccine reaction Symptoms resolved. Told patient if start to feel bad again let someone know (husband, COVID hotline, PCP). Increase fluids, discussed sleep hygiene.Patient and/or guardian verbalized understanding
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| 69 | 2021-02-28 | numbness, tingling |
She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehen...
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She reported feeling like her throat was closing and was also experiencing lightheadedness, apprehension, and numbness/tingling in her left hand. Her vital signs were monitored every 5 minutes for 20 minutes, and she was given 20 mL (50 mg) of liquid Diphenhydramine. Her signs and symptoms subsided, and she was ambulatory and stable with no distress at dismissal from clinic.
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| 69 | 2021-02-28 | muscle spasms |
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa...
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muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
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| 69 | 2021-02-28 | numbness and pain in extremities, pain in extremity |
temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! se...
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temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! severe Headache neuropathy SEVERE Hands were like frozen
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| 69 | 2021-03-01 | feeling cold |
1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelin...
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1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement. Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work. Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm. Slept in 2 hrs increments all night. Saturday sipped fluids
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| 69 | 2021-03-01 | tingling, muscle twitching, feeling hot |
SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - p...
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SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - pins and needles in the face, hands, feet, and very warm face. (RASH AND ITCHING AROUND INJECTION SITE NEXT DAY AND ONGOING. ) Slowly, twitching started sporadically lasting 1 - 3 seconds with 5 - 10 minutes in between. Length of twitching stayed the same but slowly became more often. I knew something was going to happen, so I did not want to go home not knowing if it would become more severe or when it would become severe. As time wore on, twitching and body movement increased especially in left thigh where a stronger seizure usually starts. In time, it became almost constant with arm, shoulder and leg movement and then increased to sporadic whole body movement. Took Klonopin. Took about 15 - 20 minutes to take effect I was attended to by doctor and EMS.
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| 69 | 2021-03-01 | tingling | light headed tingling fingers |
| 69 | 2021-03-02 | burning sensation | 9 pm noticed red puffy area on face with burning sensation Woke up 3/03 with headache |
| 69 | 2021-03-02 | facial pain, nerve pain |
At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pai...
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At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pain, jaw pain that included my teeth being very sensitive. Tylenol helped ease the pain. It lasted 13 hours. The following night, I had the same exact pains on the left side of my head that lasted 12 hours. For 2 days after, I had a few twinges of pain on the left side of face, mostly below the ear, didn't last more than a couple minutes.
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| 69 | 2021-03-02 | weakness |
Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and...
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Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and was worse late in the day. Fatigue and weakness for 48 hours.
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| 69 | 2021-03-02 | pain in extremity |
Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received he...
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Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received her vaccination. It was her first dose in the PFIZER series. Pt received her vaccination in the L arm and started noticing an itchy sensation to the left antecubital fossa. Realized it was reddened and alerted staff. This RN noted reddened rash, approx. 6 inches in length, with one raised hive to area. Pt denied any difficulty breathing or trouble swallowing/speaking. Pt was speaking in full sentences throughout whole event. Pt's vital signs were obtained with HR 70, 97% on room air for oxygenation, and BP 152/88. Pt was given 25mg of Benadryl PO by this RN. Pt was reassessed at approx. 0804 and noted that the itchiness was going away as well as the rash. She continued to hold conversation and denied any further symptoms. Redness within rash was fading and pt states she just had a slight burning sensation to the area. Repeat BP was 160/90. Pt was released home at 0815 with her husband. Rash improved and pt denied any further concerns or symptoms. recommended to get Benadryl to have at home in case needed.
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| 69 | 2021-03-02 | pain in extremity | Woke up day after vaccination, left arm very sore ,stiff with significant swelling |
| 69 | 2021-03-02 | unresponsive to stimuli |
became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was ...
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became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
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| 69 | 2021-03-02 | feeling hot |
felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to...
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felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows: About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 69 | 2021-03-02 | tremor |
shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contact...
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shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-03-02 | weakness, hot flush |
she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing...
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she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021. Information about Lot/Batch number has been requested.
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| 69 | 2021-03-02 | pain in extremity |
sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness a...
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sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
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| 69 | 2021-03-02 | pain in extremity |
tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-y...
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tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Feb2021 at 14:30 at a single dose, for COVID 19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as "other". On 12Feb2021, the patient had a very sore arm. The patient was tired the next day (13Feb2021). The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-03-04 | feeling cold, feeling jittery |
Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for...
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Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for about 4 days but no fever Headaches that were nagging for about 4 days Diarrhea the first that did not last long Nausea that lasted for about 2 eqyw
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| 69 | 2021-03-04 | flushing, feeling hot |
Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of h...
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Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of hypertension, allergies to PCN, and severe allergic reaction to flue vaccine 2 years ago. Pt offered adult dose of diphenhydramine. Pt refused diphenhydramine. Pt offered EMS. Pt denied EMS. Pt advised to wait 15 extra minutes. At 1417 pt reported dry throat and feeling hot. Flushing was observed by RN. Pt was moved outside. Pt was offered EMS for a second time. Pt agreed to EMS. EMS was activated at 1420. EMS arrived at 1430 and assumed care. Pt left vaccination site at 1435 and transported to ER.
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| 69 | 2021-03-04 | tremor |
TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXP...
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TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXPERIENCED TREMORS GENERALIZED BUT WORSE IN HER HANDS WHICH STARTED APPROXIMATELY 25 MINUTES AFTER INJECTION OF COVID-19 (PFIZER) VACCINE.
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| 69 | 2021-03-05 | feeling hot |
2125-patient reports she is not feeling well, while sitting in the waiting room. Patient reports she...
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2125-patient reports she is not feeling well, while sitting in the waiting room. Patient reports she feels a warm sensation all over her body and epigastric discomfort. Vital were assessed. Denies chest pain, shortness of breath, difficulty breathing, dizziness. Patient reports symptoms were not improving, patient sent to ER for evaluation at 2140. Report given to PA. no medication given in clinic. Patients airway is patent, alert and oriented to person, place, time. answering questions appropriately. walking on own. Husband transported patient to hospital.
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| 69 | 2021-03-05 | pain in extremity |
It started around 8:00 PM on 3/4/2021 with severe pain in the arm, lots of fever, excruciating heada...
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It started around 8:00 PM on 3/4/2021 with severe pain in the arm, lots of fever, excruciating headache, heavy tiredness, chills along with fever. I tried Advil at first. No relief. I switched to Tylenol with the same results. No appetite. Tolerated some Saltine crackers with sips of Coca Cola, and sips of water. Stayed in bed all of 03/05/2021. I didn't stomach any meals, felt like throwing up, but didn't. Today 03/06/2021, left the bed, showered, still running a fever and not feeling like eating.
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| 69 | 2021-03-05 | flushing |
Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free be...
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Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free benadryl 25 mg po at 1500 at 1507, she was having continued itching and flushed at 1515, itching reduced, flushing improving at 1518, itching to hands, neck improved Face still flushed and sweating
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| 69 | 2021-03-06 | pain in extremity, tremor |
I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I we...
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I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I went to sleep in my clothes. I woke up a few hours later with a pounding headache; the sound of my heartbeat like a snare drum in my ears, nauseated and with a very, very sore arm. Later, throughout the night, I had continuous head pain, nightmares, chills and soreness. I am better today, but still shaky, I took one Naproxen tablet at around 1 am, as well as a melatonin.
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| 69 | 2021-03-06 | flushing | patient became flushed, stated hard to breathe, headache, nausea and back ache |
| 69 | 2021-03-07 | weakness, pain in extremity, tenderness |
25 hrs after vaccination I developed a severe headache, body aches, low fever, weakness, fatigue, le...
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25 hrs after vaccination I developed a severe headache, body aches, low fever, weakness, fatigue, left arm achy and sore to touch. So far, has not improved in another 24 hrs.
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| 69 | 2021-03-07 | weakness |
A week of extreme weakness, dizziness, aches and pains, headaches. Just couldn?t get out of bed. Aft...
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A week of extreme weakness, dizziness, aches and pains, headaches. Just couldn?t get out of bed. After a week I have weakness and dizziness.
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| 69 | 2021-03-07 | weakness, tingling |
Approximately 30-40 minutes after vaccine, I experienced blurred vision in my left eye and had left ...
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Approximately 30-40 minutes after vaccine, I experienced blurred vision in my left eye and had left sided tingling and weakness. I have had several episodes of that since, and my vision in that eye continues to be somewhat blurred. I have continued to have swollen lymph nodes in many areas of my body as well as pressure in my head.
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| 69 | 2021-03-07 | migraine |
Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital B...
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Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital Blood pressure was extremely high
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| 69 | 2021-03-07 | discomfort, sensory loss, tingling, pain in extremity, numbness |
My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting o...
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My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.
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| 69 | 2021-03-07 | weakness |
Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week. ...
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Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week. During this time I noticed loss of movement and strength in both legs. This continued to worsen. By about 2-23-21 (day I received 2nd dose) muscles in legs were very constricted making it difficult to walk. Plus I have lost strength in both hands. Contacted my doctor who refereed me to a Neurologist . The Neurologist ran tests on 3-5-21 that indicate that I have nerve damage. Doing physical therapy in an attempt to loosen muscle constriction and regain strength.
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| 69 | 2021-03-07 | numbness |
two days after receiving the vaccination my left arm went numb. the next am i went to urgent care an...
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two days after receiving the vaccination my left arm went numb. the next am i went to urgent care and they said pinched nerve - no improvement so went to ER on Monday morning. It was determined that the arteries in my left arm were completely blocked and I was not getting any blood flow to limb. Sent from ER and within hours an emergency throbectomy was performed to save my left arm/hand. Spent a couple days in ICU, total 5 in hospital. Doctors DO NOT KNOW if COVID 19 vaccine could have caused or be partially responsible so they advised me to file a report.
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| 69 | 2021-03-08 | flushing, tingling, feeling hot |
Complain of feeling hot, flashed, scratchiness in the back of throat. No swelling, hives, itching, S...
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Complain of feeling hot, flashed, scratchiness in the back of throat. No swelling, hives, itching, SOB. Patient had tingling in hands and face that patient stated is normal with her MS. T98.1, P80, R18, BP139/89, O2 sat 94%. Pt advised to take Benadryl when she gets home because it makes her very drowsy
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| 69 | 2021-03-08 | pain in extremity, feeling jittery |
Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt v...
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Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt very thick and heavy. Throbbing. Pulsating, as though I could feel my heartbeat in my arm when I went to bed. Took to Tylenol or sleep would have been impossible. Woke up to a less painful arm and it improved throughout day feeling almost normal by bedtime 24 hours later. Took 2 Tylenol to ensure sleep. Woke up Tuesday morning and arm felt almost 2100% normal. I thought, wow, that wasn't so bad. BUT I WAS WRONG. Tuesday mid morning, I began to feel what I would describe as jittery. Around 11:00 am a wave of nausea washed over me and subsided. I thought maybe I needed to eat as I hadn't yet so I had lunch. After lunch I began to feel nauseous again and like diarrhea was coming. After going to the bathroom, the nausea started building again, and the diarrhea recurred, and the nausea heightened. By mid afternoon I was on the floor hugging the toilet bowl wanting to vomit, waiting to vomit, groaning. It's been years since I've had nausea or vomiting and the whole experience was unexpected from what I read about possible reactions. I wondered if it was food poisoning but my husband and I had eaten the same thing and he was fine. Finally about 3:30-4:00, 48 ours post vaccine, I threw up multiple times, perhaps 5 times. After about 4:30 pm it was over. I was worried that if I ate again I'd be sick so I only drank decaf tea. I felt exhausted from the ordeal but very wired and jittery too. I crawled into bed hoping for sleep. No luck. At 3:00 am I was still watching the clock and shocked that I couldn't sleep. I had to get up at 6:30 in the morning due to some construction at our home. I was legit exhausted Wednesday. I no recurrence of the nausea or diarrhea after the bout on Tuesday afternoon. I ate modestly but normally on Wednesday and slept normally Wednesday night. Nothing more to report, although I read that up to a week later some people experienced a reaction so I wanted to give it a week to see if anything else would happen. Nothing else to report.
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| 69 | 2021-03-08 | flushing |
patient was in observation and stated that she was ahe started to feel flushed. Notified medics and ...
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patient was in observation and stated that she was ahe started to feel flushed. Notified medics and vital signs were taken blood pressure was elevated at 197/92, pulse 82 an d oxygen saturation 96%. Patient stated that she had " white coat syndrome" and was nervous. Patient refused further evaluation at the hospital and states that she was feelig well after a few minutes.
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| 69 | 2021-03-09 | hot flush, feeling jittery |
About 5 hours after vaccination, unusual ?stingy? headache and tiredness, some malaise after nap. Sy...
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About 5 hours after vaccination, unusual ?stingy? headache and tiredness, some malaise after nap. Symptoms lessened, then disappeared during morning of next day. About 30 hours after vaccination, hot flashes (no fever), chills, tired, but jittery with difficulty sleeping, dizzy, head felt ?weird?, - mostly diminished in morning. About 48 hours after vaccination, headache and tiredness returned -still no fever. Very little soreness in arm over the past two days since injection.
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| 69 | 2021-03-09 | bell's palsy |
PT WAS DIAGNOSED WITH BELL"S PALSY AFTER THE SHOT, HER RIGHT SIDE MOUTH IS SAGGING, AND HER EYES CAN...
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PT WAS DIAGNOSED WITH BELL"S PALSY AFTER THE SHOT, HER RIGHT SIDE MOUTH IS SAGGING, AND HER EYES CANT BE CLOSED FULLY
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| 69 | 2021-03-09 | pain in extremity |
Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the ...
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Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the injection. Since has had multiple issues and concerns, such as SOB, dizziness, joint and right arm pain, fatigue and nausea that started about an hour after receiving her vaccine. She said she has SOB at rest but with any type of exertion she is gasping for air. Rates her joint pain off the charts with walking and is bent over.
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| 69 | 2021-03-09 | night sweats |
Severe inflammation of thyroid only in the evening which radiated out under jaw to ears. Lasted appr...
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Severe inflammation of thyroid only in the evening which radiated out under jaw to ears. Lasted approx.4 weeks. Fever every evening for approx. 4 weeks. Night sweats every night for the past 6 weeks and still continuing. Some of these have been drenching every hour for 4-5 hours. Sometimes less severe but these are ongoing. During the day none of these symptoms existed except a little soreness when touching the thyroid.
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| 69 | 2021-03-09 | pain in extremity |
Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left a...
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Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient
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| 69 | 2021-03-09 | discomfort, weakness, feeling cold |
Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my ...
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Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my skin;" stomach and diet off; bowels off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; slightly headache; low energy; Thursday, the second day after the shot: 99.7 temp; stomach and diet off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Friday, day three: stomach and die off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Saturday, day four: chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth Sunday, day five: chest and upper back pressure; deliberate taking of a deep breath Monday, day six: chest and upper back pressure; deliberate taking of a deep breath Tuesday, day seven: chest and upper back pressure; deliberate taking of a deep breath Wednesday, day eight: chest and upper back pressure; deliberate taking of a deep breath
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| 69 | 2021-03-09 | breast pain |
her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; ...
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her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported. There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts. She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
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| 69 | 2021-03-10 | burning sensation |
5 minutes after receiving the vaccine I felt very woozy but I did not think it was significant so I ...
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5 minutes after receiving the vaccine I felt very woozy but I did not think it was significant so I didnt alarm the nurses. it passed about 2 minutes later. I was fine. around 4 pm I had sudden burning and aching in my lower back and legs and I was shopping at the time so I went to use the restroom and could not hardly bend to sit on the toilet and I had a very hard time getting back up off the toilet. I went home and I alternated heat and ice on my back and I tried strengthening exercises and nothing helped. I tried Aleve and that gave me some relief. by the next monday night I was completely fine!
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| 69 | 2021-03-10 | pain in extremity | Left arm extreme aching, then progressed into back, then down right arm |
| 69 | 2021-03-10 | pain in extremity | Painful lymph nodes under arm and in breast |
| 69 | 2021-03-10 | weakness |
Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea ...
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Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea in ileostomy bag. I did not sleep Monday 3-8 night. Vomiting .stopped the next day. Little appetite. Temp 3/11 was 99.3 slightly high. No adverse event after first dose 2/15/21.
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| 69 | 2021-03-10 | weakness, tremor |
diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which ...
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diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which occurred 10 minutes after injection. Patient went to the emergency department within the Medical Center. Patient had an EKG and blood work. Patients symptoms were worse on exertion. She is followed by pulmonology and has been taking prednisone 40mg daily for the past and Bactrim for prophylaxis. Patient had respiration rate in the 30s, and was saturating well on 3L oxygen which is her baseline. EKG was normal. Patient tested negative for COVID-19 on 3/10/21. Patient was admitted to general medicine floor.
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| 69 | 2021-03-11 | burning sensation |
69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who expe...
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69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who experienced headache, burning to the injection side, and chest tightness immediately after her 1st dose of the vaccine. Denies shortness of breath, palpitations, dizziness, or any other symptoms. She did not look in any acute distress, her lungs clear to auscultation bilaterally, cranial nerves 2-12 intact and no pronator drift. Vital signs 98%RA, HR 76 , BP 150/90. She was observed in the medical tent for total of 30 minutes and given water and was reassured. She felt completely asymptomatic prior to discharge and confirmed that her headache, burning side, and chest tired were all completely resolved. She was ambulatory before discharge and was advised to call 911 or go to the nearest emergency room if any she she verbalized understanding and agreed to the treatment plan.
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| 69 | 2021-03-11 | weakness |
Hypotension leading to septic shock and DIC. Started 6 hours after injection. Discharged from hos...
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Hypotension leading to septic shock and DIC. Started 6 hours after injection. Discharged from hospital on 2/24/21. Left with much worse dementia. Weakness progressed. Now on hospice
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| 69 | 2021-03-11 | inability to speak |
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi...
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Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
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| 69 | 2021-03-11 | numbness and pain in extremities |
Within the first 15 minutes, I had neuropathy of my fingers and toes which lasted about 10 days. Wh...
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Within the first 15 minutes, I had neuropathy of my fingers and toes which lasted about 10 days. When I mentioned the neuropathy to a nurse on-site, they took my blood pressure, the systolic of which had sky rocketed 70 points. Over the next 30 minutes, my blood pressure only came down 20 points. The following week, my average blood pressure was 125/73. Shortly after the neuropathy ended, twelve days after receiving the vaccine, the COVID arm rash appeared on my upper left arm, which remained for about a week.
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| 69 | 2021-03-12 | tenderness, tingling |
Woke @ 4am w swollen lips.tht felt like a thousand needles poking cheeks and eyeballs tht felt very ...
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Woke @ 4am w swollen lips.tht felt like a thousand needles poking cheeks and eyeballs tht felt very hard and tender...cheeks and eyeballs resolved p app 8hrs but lips remained swollen several days.
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| 69 | 2021-03-13 | weakness | Fatigue, sleepyness, lack of energy, congestion |
| 69 | 2021-03-13 | tenderness |
Very sharp pain about one inch below left collarbone, halfway between neck and shoulder. Remained no...
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Very sharp pain about one inch below left collarbone, halfway between neck and shoulder. Remained noticeable, and very sensitive to touch, for 8 hours. Gone the next morning. About 6 hours after injection had frequent need to clear my throat that occurred for about 3 hours.
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| 69 | 2021-03-14 | feeling hot |
Called to vaccination area at 1056 regarding a vaccine response to vaccine administered at 1055. Cli...
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Called to vaccination area at 1056 regarding a vaccine response to vaccine administered at 1055. Client c/o "trouble getting a deep breath", feeling "hot on the inside", and dizziness. Onsite EMS was called to evaluate. Vital signs taken and were stable. Lungs clear. Benadryl administered at 1100. Client stated she was feeling better and that symptoms had resolved prior to leaving site. Vital signs obtained by EMS again at 1127 prior to client leaving site at 1130. Vital signs stable. Lungs still clear. Client left site with spouse driving.
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| 69 | 2021-03-14 | night sweats |
Extreme fever chills and night sweats Began after the second dose of the COVID 19:vaccine and still...
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Extreme fever chills and night sweats Began after the second dose of the COVID 19:vaccine and still continue
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| 69 | 2021-03-14 | feeling cold | Fever, chills, body aches, headach, fatigue, slight nausea |
| 69 | 2021-03-14 | pain in extremity |
First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm sor...
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First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm soreness lasting 2 days. Second dose administered about 3:00pm about 1hour later injection site soreness. Next day about 4:30pm extreme arm pain, 100.4 fever and chills. Took 2 Tylenol. Approx 11:30pm no fever or arm soreness.
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| 69 | 2021-03-14 | pain in extremity |
Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have trigg...
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Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have triggered it. It is not covid but cough of long-standing. The next day I had sore arm, muscle pains, cold body temperature (97.1 F), and wheezing. Wheezing was new and it hurt and worried me. Intense fatigue. Wheezing has resolved but the rest still there and it is 11 days since vaccine
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| 69 | 2021-03-14 | pain in extremity |
My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction...
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My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction. Approximately 20-25 minutes after the shot, while driving home, I felt dizzy and light-headed. By the evening, I had a fever, chills, headache, body aches, pain in my left arm (shoulder, elbow down to my wrist); nausea and vomiting. Condition lasted Tuesday evening and throughout Wednesday. By Wednesday evening I felt a little better and by Thursday afternoon, most of the symptons had dissipated
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| 69 | 2021-03-14 | pain in extremity |
Next day after shot: Fatigue first, vomited once, had chills, temperature 101.8, reduced appetite. ...
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Next day after shot: Fatigue first, vomited once, had chills, temperature 101.8, reduced appetite. Following day okay except for sore arm, fatigue, lack of appetite.
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| 69 | 2021-03-14 | nerve pain |
Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain wors...
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Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain worsening.
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| 69 | 2021-03-14 | feeling cold, night sweats | Very hard chills, fever, nausea, night sweats & dizziness |
| 69 | 2021-03-15 | migraine, tremor, weakness |
16 hours after receiving the shot, I woke up with a very rapid heartrate (120). It did slow down so...
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16 hours after receiving the shot, I woke up with a very rapid heartrate (120). It did slow down somewhat (to the 90s) after a while. However, sporadically over the next few days, I did feel it was elevated. Later that day, one day after getting the shot, I developed a severe migraine headache--which included nausea and two bouts of vomiting (1 in the late afternoon and one in the evening of March 12th). The headache resolved sometime on Sunday, March 14th although I felt a bit weak and shaky. Currently, five days after receiving the shot, I feel a bit "shaky", and feel that my heartrate is rapid on occasion.
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| 69 | 2021-03-15 | pain in extremity | Bad Chills, body aches. Headache Sore arm |
| 69 | 2021-03-15 | feeling cold |
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirs...
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Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
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| 69 | 2021-03-15 | flushing |
Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, ...
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Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, swelling of tongue
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| 69 | 2021-03-15 | tremor, tension headache |
at 10 minutes....throat began to swell and close. At 45 min, face was getting puffy. At 2 hrs - he...
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at 10 minutes....throat began to swell and close. At 45 min, face was getting puffy. At 2 hrs - head felt tight. At 3 hrs - heart racing, shaky, but blood pressure was normal.
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| 69 | 2021-03-17 | flushing |
3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity t...
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3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity to light, oral sore spots, ( but not open sores ) and a flushed face. There was no fever. I took Tylenol for the aches and stayed restful, napping during the day . By 03/06/21 I felt fine.
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| 69 | 2021-03-17 | weakness |
Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospita...
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Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospital says it could not be caused by the vaccine 2 covid
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| 69 | 2021-03-18 | feeling cold | 03/17: Head ache 03/18: Left-side body ache; overall bad; chilled; no fever |
| 69 | 2021-03-18 | pain in extremity |
Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-ye...
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Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number LC3302), via an unspecified route of administration in the left arm on 12Feb2021 at 17:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes (diagnosed 4-5 years ago). The patient did not have any relevant family medical history. Concomitant medications included echinacea and vitamins, both from an unknown date at an unknown dose for an unknown indication and unspecified medications for diabetes, cholesterol and thyroid, all started prior to the vaccine. The patient previously received a shingles shot (unspecified product) for immunization and experienced injection site soreness. The patient did not receive any other vaccines on same date of the BNT162B2 vaccine and no prior vaccinations within 4 weeks of the vaccine. On 12Feb2021 the patient experienced a cold approximately five hours after the vaccination (reported as 21:30 - 22:00) which was a little worse on Saturday but started to get better and a sore left arm within a few hours of receiving the vaccine (exact time unknown). The events did not require a visit to ER or physician's office and there were no relevant tests performed. The patient stated they have not had a cold in over a year and would like to know if it is a symptom of the vaccine. The patient reported she is taking echinacea liquid and it usually helps within 36 hours and now this is her third day. It has gotten better because she takes echinacea and vitamins as well. The patient stated her left arm was sore, but not bad. She first stated it was 3-4 inches above elbow and later stated it was about 4 inches from shoulder and she did not think it was in the muscle. The patient has an appointment for her second dose in 4 weeks, the patient inquired if there will be an issue with her receiving second dose in 4 weeks instead of 3 weeks. The clinical outcome of the cold and sore left arm was recovering.
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| 69 | 2021-03-18 | migraine |
HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHI...
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HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHING DIFFICULTIES
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| 69 | 2021-03-18 | numbness |
On way home, I realized my face was somewhat numb, like when you?ve had dental work. It lasted about...
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On way home, I realized my face was somewhat numb, like when you?ve had dental work. It lasted about 40 hours, gradually lessening in intensity
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| 69 | 2021-03-18 | pain in extremity | Pain on left arm. Limited motion of left arm. |
| 69 | 2021-03-18 | pain in extremity |
Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got w...
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Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got worse; This is a spontaneous report received from contactable consumer, the patient. A 69-year-old elderly female received the first dose of BNT162b2 (solution for injection; Lot EN6201 expiry not provided) as a single dose via unspecified route in the right arm on 14Feb2021 at 11:30 AM (at 69-years-old) for COVID-19 immunisation. Relevant medical history included asthma, hypothyroidism, and high blood pressure (BP). The patient has an allergy to penicillin, sulfonamide (sulfa), eggs, shellfish and peanuts and all tree nuts. Concomitant medications sans posology/indications included levothyroxine sodium (SYNTHROID), valsartan (DIOVAN), atenolol (TENORMIN), amlodipine, and diazepam (VALIUM NOVUM). The patient did not receive any other vaccines on the same date. The patient denied being diagnosed with COVID-19 prior to the vaccination. The patient reported that on 16Feb2021 at 05:00pm she experienced a sore arm, body aches, fatigue, headache, upper stomach cramps, chills , sensitive skin (no hives) and these symptoms got worse on the second day and continue (fifth day not including day of vaccine), The patient was tested for COVID via nasal swab PCR on 19Feb2021 and was negative. There was no treatment received. The outcome of the events, sore arm, body aches, fatigue, headache, upper stomach cramps, chills, and sensitive skin (no hives), was not recovered.
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| 69 | 2021-03-18 | hot flush, feeling jittery |
crazy blood pressure fluctuations the highest was 188/89/BP was around 159 or 150 then it came down ...
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crazy blood pressure fluctuations the highest was 188/89/BP was around 159 or 150 then it came down to 136/71; feeling real jittery; hot flush feeling like an adrenaline rush in her upper chest and arms; heart pounding/highest pulse was 106; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EM5318), via an unspecified route of administration, administered in the left upper arm on 09Feb2021 at 11:00 at a single dose for COVID-19 immunization. Medical history included premature ventricular contractions (PVC) from an unknown date wherein her pulse goes up into the 120s and had to go to the ER. There were no concomitant medications. The patient previously received Pneumovax 23 on 14Jan2021. The patient called about the Pfizer COVID 19 vaccine. The patient had the shot on 09Feb2021 and the 10th she was fine then on 11Feb2021, she started having side effects. She is calling it side effects but what she is describing, she has these episodes periodically but she has not had one in 2 years but it was bad one and it happened 2 days after her vaccine, she is not sure if it was side effect but she doesn't want to mess with it so she wants to tell someone. On 11Feb2021, the reaction started around 1:30 PM. She started feeling real jittery, she was hot flush feeling like an adrenaline rush in her upper chest and arms down to her elbows. She could feel her heart pounding and she had these before but no one seems to know what causes it. She worked with it she was busy doing other things then around 4PM that day it started getting worse. She could tell her blood pressure was getting involved. She started taking her blood pressure, from 4:30 on until 12:30AM she had crazy blood pressure fluctuations the highest was 188/89 and the highest pulse was 106 but it goes up to 188 and then it would be 158, 179, 155, 119, 166 and those are the top number of the blood pressure. Her pulse pretty much stayed high 80s 90s except for the time it was 106. After midnight, her BP was around 159 or 150 then it came down to 136/71 and her pulse was 78 and she slept much better, she slept for 4 hours she woke up feeling like heart pounding but her blood pressure was 125/69 and her pulse was 74. She also has PVC and sometimes they say when she feels her heart pounding and her blood pressure and pulse are fine, they said that is probably PVC. When her blood pressure and pulse goes way up she is miserable. She had it so that her pulse goes up into the 120s with this and she has had to go to ER before. She clarifies her pulse being in the 120s and having to go the ER was in the past, prior to the vaccine. She says no one can figure out what it is. Some said it was anxiety, she sat through a whole program on anxiety and they decided not that is not what it is. But the fact that she hadn't had one of these episodes in 2 years and she had a good sized one 2 days after the vaccine, she had a really hard one that is why she thought she better report it. It has definitely gotten better she still feels jittery and heat flush every once in a while, but her blood pressure is fine. It is 139/74 and pulse 74. She can tell its still there but improved and certainly not uncomfortable. The events did not require a visit to the emergency room or the physician's office but she contacted her doctor's office and she has an online thing with them in a half an hour from the time of the report. The outcome of the event crazy blood pressure fluctuations the highest was 188/89/bp was around 159 or 150 then it came down to 136/71 and heart pounding/highest pulse was 106 was recovering while the outcome of the events feeling real jittery and hot flush feeling like an adrenaline rush in her upper chest and arms was unknown.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event blood pressure fluctuation cannot be excluded. The cardiovascular medical history is likewise a risk factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-03-18 | flushing |
immediately following injection within 1-2 minutes, she developed severe facial flushing followed by...
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immediately following injection within 1-2 minutes, she developed severe facial flushing followed by flushing and redness of the bilateral forearms and hands. She received 25mg of Benadryl and was observed for 1 hour. Symptoms resolved within the next hour or so. S
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| 69 | 2021-03-19 | discomfort |
10 hrs after vaccine woke to pain in muscle approx 1 1/2 inches below injection site. About 12 hou...
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10 hrs after vaccine woke to pain in muscle approx 1 1/2 inches below injection site. About 12 hours latter, discomfort moved to muscle around injection site, no longer below it. approx 36 hours after injection, muscle sore only when touched. All discomfort fron Vaccine gone within 48 hours.
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| 69 | 2021-03-19 | pain in extremity, tremor, feeling cold, weakness |
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shakin...
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After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
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| 69 | 2021-03-19 | weakness, tremor |
Two hours after receiving my second vaccine I became very tired. Roughly 12 hours after that (1 am)...
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Two hours after receiving my second vaccine I became very tired. Roughly 12 hours after that (1 am), I awoke with chills and shakes. When I awoke in the morning, I experienced headache, fever (99.9), body aches, chills and slight nausea. These symptoms lessened towards the end of the day. I awoke during the night (about 24 hours after first experiencing chills) in a pool of sweat. Although I didn't take my temperature, I felt like my fever had broken and most other symptoms were gone. The following morning I felt weak and tired.
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| 69 | 2021-03-20 | weakness | Headache, diarrhea, nausea, welts on face, general weakness and body pains. |
| 69 | 2021-03-20 | muscle spasms |
I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but fe...
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I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but feeling like I do I can't work; a slight temp 90.2; had choking episodes; feels like her throat is closing up when she is eating; Food get stuck in my throat; sleeping all day; tired; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included food allergies and meds allergies, anxiety, depression and blood pressure (abnormal). Concomitant medications included clonazepam (KLONOPIN) taken for anxiety from 2001, buspirone (BUSPIRONE) taken for anxiety from 2001, bupropion hydrochloride taken for depression from 2001, bupropion hcl taken for depression from 2001, and amlodipine besilate taken for blood pressure abnormal from 08Mar2021. On 05Mar2021 19:00, the patient experienced headache, and nausea. On 06Mar2021 19:00, the patient experienced sleeping all day, and was tired. On Day 2, she still had more side effects which wake her up. On 10Mar2021 19:00, the patient experienced had choking episodes, feels like her throat is closing up when she was eating, and food got stuck in her throat. On an unspecified date, the patient was upset and muscle spasms felt like something crawling in her leg and felt "crap"; she got to work but feeling like can't work. The patient reported that she had been having side effects and she was scared to have the shot because of her side effects and have when her body don't recognize it. She was asking when they go away. She has had a headache and nausea, was tired and sleeping all day. She felt like her throat was closing up when she eats. She had a choking episode and her grand daughter had to hit her on her back. She had choking episodes last night and this morning and she was now eating soft foods. She saw her doctor Monday for a regular appointment and she told him what happened. He wanted her to take the second dose but she was afraid to take it. She was afraid she will have worse side effects. Right now, she had nausea and drinking ginger ale. Her doctor called her which she was upset because he haven't seen her at all. Last time was 2019; and she just told him how she feel and want person to person. Patient reported she was not going to take 2nd dose because she do not want to go through anymore side effects. Everyone said that there were no side effects. That's wrong and she was having side-effects from day 1 on Friday night. There was an ingredient which she has allergies to. She told the nurse all meds allergies and food allergies which they told her that nothing in it will cause any side effects. They were wrong. She felt crap and she got to work but feeling like she can't work. Patient refused to take 2nd dose. Patient stated that she do not want to go through what she was going through now. The patient reported that she had a slight temp 90.2 on an unspecified date. The events required a visit to the physician office. The patient had no prior vaccinations (within 4 weeks). Outcome of events choking episodes, nausea, tired, feels like her throat is closing up when she was eating, Food get stuck in my throat was not recovered; sleeping all day was recovered on 07Mar2021; headache was recovered on 10Mar2021; and outcome of the rest of events was unknown.
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| 69 | 2021-03-20 | tenderness | Swelling, rash, itch, tenderness within 2 days |
| 69 | 2021-03-21 | difficulty speaking |
Anaphylaxis. Patient began to have symptoms 5 minutes following the vaccine injection, was provided ...
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Anaphylaxis. Patient began to have symptoms 5 minutes following the vaccine injection, was provided 50 mg IM benadryl at the site, another 50 mg IV en route to the hospital. Patient stated difficulty breathing and voice changes. Pt has history of anaphylaxis. She did not use her EpiPen, 0.3 MG of Epinephrine was administered at 550 pm in the ED. Patient discharged at 2208.
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| 69 | 2021-03-21 | tension headache, weakness |
I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn re...
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I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache. I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better. I had an anaphylactic reaction to the vaccine. Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases. Just because I didn't die or an Eppie Pen was not given to me. doesn't mean I should not be included in the statistics.
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| 69 | 2021-03-21 | numbness |
Left arm stiffness, numbness, and spasticity on 2/25/21. Overtime the stiffness and numbness involv...
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Left arm stiffness, numbness, and spasticity on 2/25/21. Overtime the stiffness and numbness involved left wrist. By 3/5/21 had numbness in left torso, left thigh, and as of 3/16/21 started getting numbness and stiffness of her right upper extremity.
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| 69 | 2021-03-21 | tingling, pain in extremity |
Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elb...
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Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elbow, and her arm was painful and heavy and tingling. This continued until the following day with the tingling and swelling. The arm is still red and it is hot to the touch and is extremely itchy. Benadryl helps with the itching.
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| 69 | 2021-03-21 | inability to speak |
Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER...
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Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER and evaluated and TPA given. Results good following drug administration sent home after two days. Some mental affects still.
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| 69 | 2021-03-22 | pain in extremity |
Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up wi...
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Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up with my finger joints stiff, swollen and throbbing with pain (this subsided on day 4) Day 3 - No symptoms Day 4 - Woke up with rash (burning) on right side of my neck, and headache.
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| 69 | 2021-03-22 | weakness |
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - be...
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Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
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| 69 | 2021-03-22 | seizure like phenomena, involuntary muscle movements, speech disorder |
seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and l...
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seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and legs shot straight out; This is a spontaneous report from a contactable consumer reporting for their sister (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in arm right on 24Feb2021 (lot number: EL1269, expiry date not reported) as single dose for covid-19 immunisation. Medical history included stroke from Sep2020 to an unknown date, cognitive impairment from having stroke, chorea movement of the mouth (she is on medication), blood pressure, cholesterol, anxiety, blood thinner, bones, mouth movements and tooth cleaning from an unknown date and unknown if ongoing. Concomitant medications included ongoing amlodipine at 2.5 mg, daily taken for blood pressure abnormal; ongoing rosuvastatin at 20 mg, daily (has been taking for years) taken for blood cholesterol abnormal; ongoing aspirin [acetylsalicylic acid] from Sep2020 at 81 mg, daily (was on a higher dose but was decreased); ongoing sertraline from Oct2020 at 25 mg, daily taken for anxiety; olanzapine from 20Jan2021 at 2.5 mg, unspecified date at 5 mg, 7 mg, and from 17Feb2021 and ongoing at 7.5 mg, daily taken for mouth movements; ongoing alendronate sodium at 70 mg, weekly (has been taking for years) taken for bone disorder; ongoing apixaban (ELIQUIS) from Sep2020 at 5 mg, daily taken for anticoagulant therapy. It was reported that the patient received the first dose of the Covid-19 vaccine on 24Feb2021. Four days later on 28Feb2021, she had seizure like symptoms. It was not a seizure but it looked like it. She is not sure if this is related. The doctors ruled it out. They said it would be immediate. This could be a coincidence. She is on medication for Chorea movement of the mouth. She was taken to the emergency room and she was admitted to the hospital. Her arm did not even hurt. She was incoherent for about an hour. Things seemed to calm when they gave her IV fluids. Her arms and legs were straight out until she went to the emergency room. She made a noise that sounded like a bazooka. It lasted for a little while. The gave her fluids and took her vital signs. Her arms and legs were no longer stuck out. She was calm when they laid her on the table in the emergency room. It was also reported that the patient was drooling. It was reported that they ran all kinds of tests, MRI, EKG, brain wave thing, unable to find any sign of seizure. Her arms and legs shot out and she sounded like an automatic gun, "ah, ah,ah,ah, us". She told them in the hospital, that she had the covid vaccine, and they said no, it was not that because it was to long after the vaccine. The patient was hospitalized for seizure like symptoms from 28Feb2021 to 03Mar2021. The patient underwent lab tests and procedures which included computerised tomogram: normal, electrocardiogram: normal both on 28Feb2021, magnetic resonance imaging: negative on 02Mar2021, scan brain: normal on 01Mar2021. Therapeutic measures were taken as a result of incoherent and was making a bazooka sounding noise which included IV fluids. The patient recovered from seizure like symptoms, was making a bazooka sounding noise, arms and legs shot straight out on 28Feb2021, from incoherent on 01Mar2021, while the outcome of drooling was unknown.
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| 69 | 2021-03-23 | pain in extremity |
Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, la...
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Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, lack of sleep, and lack of hunger or thirst.
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| 69 | 2021-03-23 | weakness |
Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That n...
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Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That night my arm was sore, came down with aches, headache, tiredness, then chills, fever, weakness, dry heaves, light headedness but did not passout. Stayed in bed for two days, Friday n Saturday. Got up Sunday layed around all day. Got up Monday, Tuesday and today, Wednesday the 24th with headache and feelilng blah, no energy. Vaccine site still slightly sore and itches too. still not feeling myself, today is Wed. Mar 24. May not have any bearing on vaccine but too much of a coincidence.
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| 69 | 2021-03-23 | pain in extremity |
sore arm initially after injection on monday mar 22- next day arm was itchy and also felt tired and...
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sore arm initially after injection on monday mar 22- next day arm was itchy and also felt tired and had slight temperature of up to 99.6 the second evening-around the second day by 10PM felt great except arm felt very itchy (removed bandaid as thought maybe latex issue?) and tried not to scratch- wed morning mar 24, had swollen lymph nodes left arm and also red rash at injection site and a bit lower and off to one side and some raised red dots-had no issues with initial vaccine shot- baby book shows that I had delayed rash reaction to child hood vaccines in 1952
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| 69 | 2021-03-24 | pain in extremity |
1.DOSE #1: EXPERIENCED TINNITUS IN BOTH EARS FOR FOUR EVENINGS IN SUCCESSION FROM TUESDAY, MARCH 2 ...
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1.DOSE #1: EXPERIENCED TINNITUS IN BOTH EARS FOR FOUR EVENINGS IN SUCCESSION FROM TUESDAY, MARCH 2 THROUGH FRIDAY MARCH 5. THE TINNITUS SUBSIDED GRADUALLY OVER THE NEXT 2 WEEKS (APPROXIMATELY). I AM NOT CURRENTLY, AS OF THIS DATE (MARCH 25) , EXPERIENCING THIS. ASIDE FROM A MINOR SORENESS TO MY ARM LASTING LESS THAN 30 MINUTES, I COULD NOT 'FEEL' THIS INJECTION AND HAD NO OTHER ISSUES FOLLOWING THE VACCINE DOSE #1 UNTIL THE FOLLOWING: 2. DOSE #2: AT ABOUT 9:30 AM ON MONDAY, MARCH 22. THE INJECTION (LEFT ARM, AGAIN) WAS, IN COMPARISON TO THE FIRST 'JAB', CLEARLY UNCOMFORTABLE BUT THIS DID NOT CONCERN ME. HOWEVER, ON MY DRIVE HOME (ABOUT 20 MINUTES) MY ARM GRADUALLY BECAME VERY SORE, AND CONTINUED TO BE PAINFUL AND GET WORSE OVER THE FOLLOWING HOURS. I COULD NOT USE OR LIFT MY LEFT ARM WITH SIGNIFICANT PAIN NOT ALEVIATED BY IBUPROFEN (3 TO 4 AT A TIME). THIS CONTINUED THROUGH WEDNESDAY, MARCH 24 AT WHICH TIME I TOOK ONE (1) TYLENOL AND ONE (1) IBUPROFEN, AND THAT HELPED WITH THE ACHE. AS OF THURSDAY, MARCH 25 (WHEN I AM RECORDING THIS) IT IS LESS PAINFUL, AND I AM ABLE TO LIFT THE LEFT ARM WITH LESS DISCOMFORT. MY SHOULDER SOCKET ALSO SEEMS TO BE LESS PAINFUL. I AM SENDING THIS INFORMATION BECAUSE I READ THAT TINNITUS HAS BEEN EXPERIENCE BY A SMALL GROUP OF VACCINE RECIPIENTS, AND BECAUSE I AM CONCERNED THAT PERSONS THE EXPERIENCE WAS MORE THE WAY THE VACCINE WAS INJECTED (MAYBE NOT IN THE CORRECT LOCATION). I HAVE NOT FELT THE NEED TO SEE A PHYSICIAN OR OTHER HEALTH PROVIDER. I HAVE CHANGED MY insurance AND AM REVIEWING NEW PROVIDERS.
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| 69 | 2021-03-24 | weakness |
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day af...
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Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
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| 69 | 2021-03-24 | flushing | Flushed sensation with rosy cheeks, given Benadryl with improvement |
| 69 | 2021-03-24 | breast pain |
It?s either a weird reaction to the COVID-19 Vaccine or a coincidence. I may have had a reaction to ...
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It?s either a weird reaction to the COVID-19 Vaccine or a coincidence. I may have had a reaction to the Pfizer COVID-19 vaccination. To support my breast reconstruction implants after a double mastectomy in 2013, I have ?internal slings? built with SurgiMend. I first attributed soreness under my breasts to my new puppy pulling as she learned to walk on a leash in late February. Last week the area was so painful I thought I had torn the support slings and would need to call my oncologist for a referral. I have now realized the soreness days coordinated with my two vaccination dates. I have heard about people with dermal fillers having a reaction and wonder if my under breast soreness was a similar type of reaction. The soreness was gone after a couple of days. Is anyone else reporting something similar? 1st Vaccination February 23, 2021 Hospital, Pfizer-BioNTech Lot EN5318 Exp: 05/21 2nd Vaccination March 17, 2021 Hospital, Pfizer-BioNTech Lot EN6205 Exp: 06/21
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| 69 | 2021-03-24 | flushing |
Light-headed, dizzy, flushed, hypertension (194/116), Fast heart rate (HR 95), ear swelling. Gave...
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Light-headed, dizzy, flushed, hypertension (194/116), Fast heart rate (HR 95), ear swelling. Gave pt 25mg PO diphenhydramine tablet. Called 911, pt brought to emergency room.
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| 69 | 2021-03-24 | pain in extremity |
PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not...
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PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not feel vaccine liquid going into her arm, asked the vaccinator if that was normal, told yes. PCP responded, not normal, called ?Moderna manufacturer (Pfizer was given per ct consent form), was told ct should have received another dose right at that time. 3/18/2021 a third dose of Pfizer vaccine was administered to the client as lead vaccine RN felt possible loss of too much vaccine when 2nd dose given, discussing with client she may have a strong reaction following this dose. 03/21/21- f/u phone call-ct very happy to have had a reaction! Sore, red, itchy arm and a bit of a headache after the third dose.
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| 69 | 2021-03-24 | facial paralysis, slurring, bell's palsy |
Patient developed symptoms of Bell's Palsy 5 days after receiving 2nd dose of Pfizer/BioNTech Covid ...
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Patient developed symptoms of Bell's Palsy 5 days after receiving 2nd dose of Pfizer/BioNTech Covid vaccine. Vaccine was given 3/7/21, facial drooping and slurred speech developed 3/12/21. Patient was evaluated in ED on 3/16/21. MRI revealed no acute process and she was diagnosed with Bell's Palsy. Treatment included Prednisone 60mg QD for 7 days and valacyclovir 1000mg TID for 7 days. Symptoms improved after 2 days of treatment and resolved 3/22/21. Follow up visit with Primary Care Physician 3/25/21.
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| 69 | 2021-03-24 | flushing |
Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and c...
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Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and chest pressure. EMS evaluated the patient on-site. The patient was hypertensive (223/180). EMS administered O2 2lpm via nasal cannula. In the ED, the patient reported they felt flushed with a headache. They remained hypertensive (167/89). ED physician admitted patient to inpatient telemetry unit for 1-day. Discharged with diagnosis of chest tightness with associated SOB and palpitations, reproducible on palpitation, troponin negative and EKG with no acute ST-T wave changes, no arrhythmia noted on telemetry, low likelihood of acute coronary syndrome. Patient was instructed to follow-up outpatient for PET stress test and 2D Echo.
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| 69 | 2021-03-24 | seizure | seizure in early morning, 6:00am |
| 69 | 2021-03-24 | numbness, tingling |
she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, sta...
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she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes; numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes.; she was getting intermittent headaches; This is a spontaneous report from a contactable Physician reported for a patient. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 17Feb2021 (Lot Number: EN6201) at age of 69-year-old at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medication(s) included atorvastatin (LIPITOR). The patient previously took first dose of bnt162b2 on 27Jan2021 (Lot number=EL3262) at single dose for COVID-19 immunization. On 20Feb2021, she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands. She reported after few days he started noticing in her bilateral toes. Patient also reported that she was getting intermittent headaches on 20Feb2021. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for 1 day. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab SARS-CoV-2 Antigen: negative on 08Mar2021. The outcome of the events was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events paraesthesia, hypoaesthesia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-03-25 | tremor |
C/O HEART RACING; SHAKING EPISODE X 3 ; AFTER THIRD EPISODE AGREED TO GO TO ER; AMBULANCE TRANSPO...
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C/O HEART RACING; SHAKING EPISODE X 3 ; AFTER THIRD EPISODE AGREED TO GO TO ER; AMBULANCE TRANSPORTED TO HOSPITAL.. SPOKE WITH CASE @0803 ON 3/26/2021; STATES THEY DID NOT KEEP HER. OBSERVED HER IN ER FOR A WHILE THEN DISCHARGED HER. NO FURTHER PROBLEMS. FINE TODAY
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| 69 | 2021-03-25 | burning sensation, tingling |
Multiple irregular erythematous lesions - burning and tingling on both forearms . Next day a 1 cm b...
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Multiple irregular erythematous lesions - burning and tingling on both forearms . Next day a 1 cm bullous lesion developed on the left forearm and following day , a half centimetre bullous lesion over another erythrmatous lesion on the right knuckle . Cross referenced on line with symptoms and record of similar symptoms . Most responsible diagnosis was erythema multiforme. This is considered an autoimmune phenomenon to vaccines. Incidentally I have a history ( pathology confirmed ) of Hashimoto?s thyroiditis in 1974. I have never had EM episode. I am a retired physician and feel confident in the diagnosis .
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| 69 | 2021-03-25 | pain in extremity |
Patient described sore arm that turn into her hand feeling stiff. Specifically her middle finger joi...
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Patient described sore arm that turn into her hand feeling stiff. Specifically her middle finger joints became inflexible. Symptoms resolved over the next week.
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| 69 | 2021-03-25 | weakness |
Saturday Night, I felt nauseated and tried to eat a cracker. I was dizzy and almost passed out. S...
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Saturday Night, I felt nauseated and tried to eat a cracker. I was dizzy and almost passed out. Sunday and Monday, had no appetite, weak, No energy. Tuesday, felt fine.
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| 69 | 2021-03-25 | pain in extremity | Sore arm (muscle not injection) for 2 days and a headache for a week - and still having. |
| 69 | 2021-03-25 | cold sweat |
patient states at about 15 mins after receiving vaccine she became lightheaded. Patient was evaluat...
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patient states at about 15 mins after receiving vaccine she became lightheaded. Patient was evaluated by RN vitals taken 110/68 P 80 SPO2 98 RA. Radial pulse regular. Vitals repeated 110/70 P 82 SPO2 98% Patient also c/o of nausea and skin was clammy. No temp noted. Patient was given ice pack to back of neck. States no improvement in symptoms Was evaluated and then transfered over to Urgent Care facility in same building
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| 69 | 2021-03-26 | feeling hot |
Couple of days after first Vaccine my left leg just above my ankle on underneath the skin it felt li...
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Couple of days after first Vaccine my left leg just above my ankle on underneath the skin it felt like the blood getting very hot and feverish for a few minutes then go away for awhile then do it again and happening constantly. Then in my 3rd week it jumped to middle of leg and then up to lower knee (all left leg), then go back down to ankle. It just feels like hot blood under the skin. I then called my primary doctor and they had me do in as I was concerned it could be a blood clot, but he checked and assured me it wasn't. Dr. said they have been seeing patients with same issue I am having, having the Pfizer shots but those people have in both legs or both arms and he really couldn't give me a answer but to report to CDC. He said to proceed with second shot which I did and still having same issue. I called my primary doctor back again this week as this continues with "Hot Spots" and I was experiencing numbness in two small toes on left leg and next 2 toes tingling and concerned for these "Hot Spots" (no rashes). He is now setting me up for a sonogram to reassure me it isn't a blood clot. I was never sick with the shot, just minor soreness in arm for following day and tired on first round. Called me a prescription in for Gabapentin 300mg.
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| 69 | 2021-03-26 | numbness |
Patient received Pfizer vaccine dose one on left arm around 10:20am. No immediate reaction. Onset at...
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Patient received Pfizer vaccine dose one on left arm around 10:20am. No immediate reaction. Onset at 10:40am of numbness in right arm. Nurse assessed patient and decided to call 911 for possible TIA. ambulance arrived at the scene around 11am and transported to ED shortly after.
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| 69 | 2021-03-27 | feeling cold, pain in extremity |
I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction...
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I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction started. Intense pain and swelling of right side of neck for 3 days. Also left wrist unable to use. Pale, ill. Vital signs ok. Then on 3/8, pain switched to left side of neck and upper back. 3/10, right neck again with swollen lymph nodes bilateral. 3/11 back of neck and upper back hurts. Intense. Could not sleep. 3/12 pain in upper quads and hips, mid pack. Feeling freezing cold. Temp ok. Called my Dr. Right side of neck continued to hurts even now (3/28/2021) but at least I can function now. I no longer feel sick, brain fog, cold. So greatly improved but not normal. Reaction has lasted a month. Vaccine number one resulted in 2 days feeling ill with upper back pain, chills but only a few days. First night vomited, passed out. First vaccine reaction was frightening but was short lived. I am a retired RN.
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| 69 | 2021-03-27 | migraine | Migraine, uncontrolled temp, fatigue, soreness |
| 69 | 2021-03-27 | pain in extremity |
Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and ...
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Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
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| 69 | 2021-03-27 | seizure |
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo...
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mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
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| 69 | 2021-03-28 | seizure, numbness, weakness |
Patient states that she had numbness in both feet and legs. Several days later these symptoms were ...
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Patient states that she had numbness in both feet and legs. Several days later these symptoms were getting worse and she went into a seizure, lost control of her use of her legs, arms and her bladder. She called 911 and transported to y Hospital ER. She had MRI w/ negative results and was given fluids. She was released to go home. Pt has appt w PCP and will discuss her symptoms w/ them. Pt is still weak, has fatigue but can use her arms and legs. She is not able to do normal activities. She had her 2nd Covid dose on 3/26/21 @ 9:20 am in her right arm.
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| 69 | 2021-03-29 | involuntary muscle movements |
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or w...
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Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
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| 69 | 2021-03-29 | weakness |
slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous r...
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slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 23Feb2021 at 07:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, tape allergy, and osteoarthritis all from unknown dates and unknown if ongoing. The patient reported taking concomitant medications. The patient previously received nubain for an unknown indication and experienced allergy, codeine for an unknown indication and experienced allergy, oseltamivir phosphate (TAMIFLU) for an unknown indication and experienced allergy, and amoxicillin sodium; clavulanate potassium (AUGMENTIN) for an unknown indication and experienced allergy.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 after receiving her injection, she went home and in a little while she had a slight headache. She took a muscle relaxer and went to bed around 11:30. When the patient got up to go to the bathroom, she was extremely dizzy, her joints ached, she was nauseated and felt really weak. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of slight headache, extremely dizzy, joints ached, nauseated and felt really weak were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 69 | 2021-03-31 | bell's palsy | Bells Palsy - no patient history of same |
| 69 | 2021-03-31 | weakness |
Within 1 day she felt body ache (typical), but within a few days she became weaker and weaker. With...
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Within 1 day she felt body ache (typical), but within a few days she became weaker and weaker. Within 1 week she could no longer walk. She was admitted for 5 days due her inability to ambulate. She continues to have weakness but now also orthostatic hypotension (previously she had hypertension--so all of her hypertension medications were stopped/changed since her symptoms are so profound--BP 68/32 at times!)
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| 69 | 2021-03-31 | weakness, paralysis |
paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chil...
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paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-04-01 | weakness |
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal...
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3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
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| 69 | 2021-04-01 | tremor |
Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited n...
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Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited non-interventional study report from the marketing program received from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in Jan2021 (Batch/Lot number was not reported) as single dose, second dose intramuscular on 15Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled syringe), subcutaneous from 2015 (Batch/Lot number was not reported) to 2020, at 40 mg (40 mg,1 IN 2- 2), subcutaneous from 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 IN 2- 2) for Moderate To Severe Rheumatoid Arthritis and lupus. Medical history included hatal hernia, blood clots on legs were not worsened with Humira, non smoker, abstains from alcohol, allergy to latex manifested by rash, allergy to Sulfa drugs manifested by upset stomach. Concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported; ezetimibe (ZETIA) taken for blood cholesterol, start and stop date were not reported; folic acid (FOLIC ACID) taken for rheumatoid arthritis, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for hiatal hernia, start and stop date were not reported; apixaban (ELIQUIS) taken for blood clots on legs, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; proline (PROLIN) taken for an unspecified indication, start and stop date were not reported; tramadol (TRAMADOL) taken for pain, start and stop date were not reported. The patient experienced lung disorder on an unspecified date with outcome of not recovered, post procedural complication on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of not recovered, tiredness in Jan2021 with outcome of recovered in Jan2021, feeling down on an unspecified date with outcome of unknown. Clinical course: Solicited report by a consumer of a 69 year old female with events of small tumor on thyroid, blood clot on both legs, coughing and shortness of breath and non-serious lungs issue caused by methotrexate, after surgery shaking a bit, tired and cloudy weather caused to feel down a bit with HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of hiatal hernia and blood clots on both legs. On unknown dates, the patient experienced lungs issue caused by methotrexate, after surgery shaking a bit and cloudy weather caused to feel down a bit. In 2016, the patient experienced blood clot on both legs. In Sep2020, the patient experienced small tumor on thyroid. On 01Sep2020, the patient experienced coughing and shortness of breath. In Jan2021, the patient experienced tired. In Jan2021, the tired resolved. Methotrexate and covid-19 vaccine were also considered suspect. In Sep2020, the patient was admitted in hospital for cough, shortness of breath and was treated with unknown oral and intravenous antibiotics. While she was in the hospital, it was discovered that she had a tumor on her thyroid. She had stayed a week in hospital. She also had a lung issue. It was discovered lots of scar tissue on lungs and according to the physician it might be from patient's lupus, rheumatoid arthritis or methotrexate. The physician said that it was caused by the methotrexate not the Humira. Methotrexate was stopped for her. Patient denied to have pulmonary fibrosis and said that according to her doctor she did not have it and she did not know her diagnosis as it was not discussed with her doctors. For problems in lungs, patient was on oxygen. Patient was off of Humira for three weeks. She had surgery on thyroid biopsy. After the surgery she was shaking a bit. She thought it was because of the anesthesia but she was fine shortly after. The biopsy results were inconclusive which looked like it was not cancerous but physician could not really tell patient if it was or it was not. On unknown date in 2020, patient had restarted Humira again. On 04Dec2020, patient had thyroid tumor removed and was on oxygen until 11Jan2021. Sometimes the cloudy weather caused patient to feel down a bit. She did not have any paper work for the blood test. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. On 15Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. The reported events except for coughing were serious as medically significant. The patient underwent lab tests and procedures which included biopsy: inconclusive in Oct2020 and in Dec2020, biopsy of tumor: inconclusive in Sep2020, blood test: unknown results in 2020, computerised tomogram of chest: unknown results in Oct2020, COVID-19 TEST: negative in 2020 and in 2020. The action taken in response to the events for bnt162b2 was not applicable, for methotrexate sodium was permanently withdrawn on an unspecified date, for adalimumab was dose not changed. The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. Information on Lot/Batch number has been requested.; Sender's Comments: Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of events, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-04-01 | numbness, burning sensation |
face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneou...
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face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021. Information about lot/batch number has been requested.
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| 69 | 2021-04-03 | weakness |
inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight we...
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inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.
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| 69 | 2021-04-06 | breast pain, weakness, pain in extremity |
If she laid her arm on it, it was painful on the left side where she got the injection between her l...
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If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-04-06 | pain in extremity |
Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report...
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Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.
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| 69 | 2021-04-07 | unresponsive to stimuli | difficulty breathing, confusion, Unresponsiveness, pulmonary congestion. |
| 69 | 2021-04-09 | pain in extremity, muscle spasms |
Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg crampin...
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Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; the inside of her thighs were a little red on the side, both legs from her thighs to her knees; the shot is already fogging her mind; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 08:30 (Lot Number: ER8727; Expiration Date: 31Jul2021, at age of 69 years old) at a single dose for covid-19 immunization. Medical history included allergies: Penicillin, Ampicillin, hair color product. The patient's concomitant medications were not reported. She was allergic to Penicillin, and Ampicillin. As a child, always reacted strongly to any vaccination she was given with a fever and flu like symptoms for a couple of days. With Ampicillin, she thought she was having a heart attack. Was told to stop Ampicillin immediately because she could get a heart attack. This was when she was 25 years old and she never went to the ER. She was allergic to a hair color product in the 1990s and it made her scalp itch really badly. Was given a cortisone shot, which she reacted immediately breaking out head to toe in hives. Has no NDC/LOT/EXP for the vaccinations she reacted strongly to as a child. Stated this was in the 1950s or early 1960s. Clarified she did not have a heart attack with Ampicillin, but it felt like she was having one. Has had cardiograms per her request and her heart and heart walls are perfect. The patient received the first dose of the Covid vaccine at 8:30 a.m. this morning on 26Mar2021. Caller reports around 11 a.m., she experienced excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh, states that the pain lasted 15 minutes. The patient reports the same pain occurred on the opposite leg around noon and lasted for 15 minutes, states that "the pain was so excruciating that she could barely stand up and it was so agonizing it was unbelievable." The patient noticed that the inside of her thighs were a little red on the side, both legs from her thighs to her knees. The patient states that she has not been in the sun, and didn't think it was anything alarming, but this is abnormal for her, states that she received the vaccine in the right arm and her upper torso is fine and her head is clear, asked if anyone else had reported this reaction. She was planned to received the second dose on 16thApr in the early afternoon. The patient stated the COVID shot was already fogging her mind. The patient felt pretty good after first shot. Felt nothing. Fifteen minutes before leaving the diner she got a leg cramp. Was sitting in a booth and didn't think much of it. Attributed it to the way she was sitting. Around 11AM when she got back to her garage, she was in agony. It hurt from the top of her rear all the way down the side to the back of her knee and rolled to the inside of her thigh. She was in such agony and didn't know if she could get out of her chair and walk. By the time she reached her apartment it has subsided. An hour later, same thing happened in the left leg. She was laying in bed and texting because she didn't' know if she would get any other reaction. This leg cramp was even worse. She was in tears. Got off bed to try and walk it off. Initial leg cramp happened in right leg. Was excruciating. Both times it lasted for 15 minutes. Both cramps were from her buttocks, all down to her knees, and rolled over into her thigh. Didn't know if that was a reaction. It is not typical of anything written on Pfizer's information or that she had heard. She was concerned. Heard about blood clots, but not with this particular product. Stated second leg cramp subsided. If it hadn't, she wouldn't have gone to the ER. Leg cramps was so excruciating. Originally thought it was coincidental and stated she will be 70 on (Date withheld). To say she has never had leg cramps before would be a lie. The way the leg cramps were timed was kind of weird. It was absolutely the same kind of cramp and location just on the a different leg. Weight: Gained 25lbs. Doesn't have COVID or any symptoms. Tested three to four months ago and was negative. Received first dose COVID-19 Vaccine today, 26Mar2021, at 08:30AM. First leg cramp began 11:00AM in right leg. Second leg cramp began Noon in left leg. Each time lasted 15 minutes. Not having leg cramps right now. Could barely talk when having leg cramps. Was worried about getting clots in legs. Otherwise she would think it was because she was getting older. She doesn't get leg cramps very often. Doesn't know when the last time she had leg cramps prior to today. Nurse technician at vaccine faculty stated caller's allergy history wouldn't be a problem and she only had to sit for 15 minutes. Received the COVID-19 Vaccine and hardly felt it. Waited for 15 minutes. She was fine until 11AM. She was fine now, but her arm might get a little stiff tomorrow. Arm was slightly tender. Surprised she felt something in her legs. Doesn't know whether to associate it with COVID-19 Vaccine or not. Has nothing to complain about in the upper torso or from the waist up. Wants to know if this is a reaction or coincidence. Stated she expected to have a stiff arm. The outcome of the event "Cramps in legs" and "pain" was recovered on 26Mar2021. The outcome of other events was unknown.
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| 69 | 2021-04-09 | pain in extremity |
blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee d...
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blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-04-09 | bell's palsy |
she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar...
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she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar2021 & was diagnosed with Bells Palsy; he had a severe headache, as well. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number - EN6206, expiry date- not reported) via an unspecified route of administration in right arm on 10Mar2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history included ongoing type 1 diabetes mellitus Stated she has had Type 1 Diabetes Mellitus for about 50 years, sleep apnoea syndrome for years, thyroid disorder and influenza immunisation. Concomitant medication(s) included trazodone. On 12mar2021, the patient started having problems on 12mar2021 & went to the emergency room on 24mar2021 & was diagnosed with bells palsy and he had a severe headache. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear and she got really tired. The outcome of bells palsy is recovering whereas the outcome of headache and tired is recovered and unknown respectively. The patient underwent lab tests and procedures which included computerised tomogram: normal on 24Mar2021 and computerised tomogram head: normal on 24Mar2021. Therapeutic measures were taken with events. The patient took Prednisone and Venlafaxine for Bell's palsy and myalgia pain and trazodone taken for sleep apnoea syndrome. The other medication used for events were Valtrex, Tylenol and Acetaminophen.
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| 69 | 2021-04-11 | tremor |
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy...
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Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
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| 69 | 2021-04-14 | tingling, numbness |
Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receivi...
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Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receiving COVID vaccine. Hands and fingers warm to the touch, injection site clear. Observed and vital signs stable. Numbness and tingling resolved 45 min after start. Client home with instructions to follow up with primary care.
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| 69 | 2021-04-14 | muscle spasms | Severe headache, long lasting cramps over entire night in both legs, and chills |
| 69 | 2021-04-15 | pain in extremity |
Patient developed left leg pain and swelling a few days after receiving her second Pfizer COVID19 va...
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Patient developed left leg pain and swelling a few days after receiving her second Pfizer COVID19 vaccination. She was seen in the ER and found to have extensive iliofemoral DVT of the left leg. She was taken for a venogram and thrombectomy and then started on Eliquis.
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| 69 | 2021-04-16 | pain in extremity |
Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of...
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Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of appetite Mar 27-30 all symptoms intensified daily, intermittent chills started on 29th Mar 31 all symptoms intensified, started using Albuterol inhaler Apr 1 all symptoms intensified, room spinning dizziness resulted in fall, temperature 99.9F Apr 2 Hospital emergency room, covid tests negative, diagnosis: diverticulitis and pneumonia. 3 intravenous antibiotics started metronidazole, clindamycin, rocephin Apr 3 admitted to hospital floor, continued antibiotics Apr 4 electrolyte infusion series started Apr 5 cough lessening, continued antibiotics and electrolyte infusions Apr 6 covid test negative Apr 7 transferred to rehab facility, continued antibiotics, electrolyte drinks Apr 8-14 antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs), negative covid test Apr 15 released to home Apr 16 diarrhea stopped, slight dizziness remains, appetite improving
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| 69 | 2021-04-16 | facial paralysis, paralysis, one side paralysis |
Observed resident with left side weakness and facial drop. neurological sign checked and left side f...
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Observed resident with left side weakness and facial drop. neurological sign checked and left side found flaccid and unable to move. 911 called. Notified of pt sent via 911 to hospital
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| 69 | 2021-04-16 | feeling of body temperature change, pain in extremity |
She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; ...
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She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; drenched in sweat; walker to back up in the bed; Nauseous; Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EM9810), on the morning of 16Feb2021 09:58 (at the age of 69-years-old) intramuscularly in the right arm as a single dose for COVID-19 immunization. The patient's medical history included knee replacement surgery years ago, dyslipidemia, depression, insomnia, constipation problems; she was taking clopidogrel (PLAVIX) because she had a hole in her heart last year (2020). This was fixed (on an unspecified date), and she was only taking PLAVIX once a day for one year, which will be until Jul2021; the patient called it a hole in her heart because that was what her heart specialist told her. Concomitant medications included: clopidogrel bisulfate (PLAVIX) taken for hole in heart from Aug2020 and ongoing, venlafaxine hydrochloride (EFEXOR), simvastatin (ZOCOR), and temazepam. The patient had an allergic reaction to sulfamethoxazole/ trimethoprim (BACTRIM), and she was also allergic to hydrocodone bitartrate/ paracetamol (VICODIN). On 17Feb2021, had a slight headache and a sore arm. On Friday, 19Feb2021, she woke up very nauseous to her stomach; no treatment received. The patient had hot and cold chills really bad. Her head was just drenched in sweat and this occurred all day long. When she did go to use the restroom and had a bowel movement, her stool was black. It was like black tar around 10:00 or 11pm, it was bad. Every time she sat down to use the bathroom, the sweating would get more intense and every time she would get up and use the restroom, she had to use a walker. Then, she used the walker to back up in the bed (19Feb2021), and she seemed to be okay. It seemed like the sweats would go away and she would get the cold chills. The patient just put a heating pad on her stomach, and this occurred all day long until Saturday morning. She mentions she does have constipation problems, but this was explosive. She couldn't get to the restroom a few times. She had several explosive bowel movements on 19Feb2021 10:00. Her husband brought the garbage pail in the bedroom and she did use plastic on the bedding. By 11:30-12pm on Saturday (20Feb2021), it completely stopped, but she was still sweating. She was so dizzy. It would hit her so bad and her head as wringing wet. However, when she would get back in the bed and lay down flat, the sweating would go away, and she would start to get the cold chills. The patient explained the sweating/hot and cold chills went away by yesterday afternoon (unspecified date). She was able to walk back and forth to the restroom with no problems. She verified all of her symptoms have improved. On 02Apr2021, the patient reported she received the second dose of the vaccine on 09Mar2021. The patient reported that sore arm and chills were important medical events, for which no treatment was received. Treatment received for diarrhea included "limgen". The outcome of explosive bowel movements and stool black was recovered on 20Feb2021, and the other events recovered on an unspecified date. Follow-up (02Apr2021): New information received from a contactable consumer includes: medical history, product data, concomitant medications, and event details. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-04-17 | pain in extremity |
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; ...
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heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 69 | 2021-04-20 | weakness |
This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and...
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This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and was admitted on 3/14/21 with weakness, lack of appetite, malignant neoplasm of brain and lung and died on 4/18/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
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| 69 | 2021-04-26 | feeling hot |
shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a ...
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shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
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| 69 | 2021-04-27 | pain in extremity |
blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; pa...
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blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; painful leg; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient received Pfizer shot a few weeks before reporting. Within 3 hours her left leg (she was inoculated on the left side) swelled up dramatically - - it was painful. Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs. She was being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. Lymphadenopathy was not resolved; the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 69 | 2021-04-30 | pain in extremity |
Extreme pain, excruciating at times, in entire upper left arm and shoulder; Extreme pain, excruciati...
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Extreme pain, excruciating at times, in entire upper left arm and shoulder; Extreme pain, excruciating at times, in entire upper left arm and shoulder; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration, administered in arm left on 05Jan2021 (at the age of 69-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the home. The patient medical history included high blood pressure, depression, anxiety, neurodermatitis, GERD and sleep apnea. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included labetalol; bupropion; amlodipine; and mirtazapine all were taken for an unspecified indication, start and stop date were not reported. On 06Jan2021, the patient experienced extreme pain, excruciating at times, in entire upper left arm and shoulder. The reported events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result of extreme pain, excruciating at times, in entire upper left arm and shoulder as the patient was told to use heating pad, get P.T. The outcome of the events was recovering. It was also reported that the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration, administered in arm right on 26Jan2021 as a single dose for covid-19 immunisation.
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| 69 | 2021-04-30 | pain in extremity |
Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn'...
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Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.
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| 69 | 2021-04-30 | pain in extremity |
This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old fem...
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This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 24Mar2021 at 15:30 (at the age of 69 years old) (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, asthma, hypertension, penicillin allergy, and sulfonamide allergy. Concomitant medications included etanercept (ENBREL) from an unspecified start date to 21Mar2021; prednisone; and unspecified blood pressure medication. The patient also received first dose of BNT162B2 for COVID-19 immunisation in left arm on 03Mar2021 at 15:00 (at the age of 69 years old) (lot number: EN6199, unknown expiration). On 25Mar2021, the patient experienced sore arm. On 26Mar2021 at 12:00 PM, the patient had cough, diarrhea, dizziness, fatigue, and loss of appetite. From 27 to 30Mar2021, all symptoms intensified daily and had intermittent chills on 29Mar2021. On 31Mar2021, all symptoms intensified, started using Albuterol inhaler. On 01Apr2021, all symptoms intensified, the patient experienced room spinning dizziness resulted in fall and had temperature 99.9F. On 02Apr2021, the patient visited (hospital name withheld) emergency room, COVID tests negative (Nasal Swab), diagnosis: diverticulitis and pneumonia. Three intravenous antibiotics started metronidazole, clindamycin, and Rocephin. On 03Apr2021, the patient was admitted to hospital with continued antibiotics. On 04Apr2021, electrolyte infusion series started. On 05Apr2021, cough lessening, continued antibiotics and electrolyte infusions. On 06Apr2021, the patient had COVID test negative (Nasal Swab). On 07Apr2021, the patient was transferred to rehab facility with continued antibiotics and electrolyte drinks. From 08 to 14Apr2021, antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs; started in Apr2021), negative COVID test (Nasal Swab). On 15Apr2021, the patient was released to home. On 16Apr2021, the patient's diarrhea stopped, slight dizziness remains, appetite improving. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination. The patient received metronidazole, clindamycin, rocephin, electrolytes as treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient was recovering from events diverticulitis, pneumonia, sore arm, cough, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F. Outcome of lost 15 lbs was unknown. The patient recovered from diarrhea on 16Apr2021. The events diverticulitis, pneumonia, sore arm, cough, diarrhea, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F assessed as serious (hospitalization) for 6 days. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-05-01 | cold extremities, pain in extremity |
Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES ...
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Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES within 2 weeks of dose. Patient reported arm pain, fatigue, and coldness to extremities
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| 70 | 2021-01-04 | pain in extremity |
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ...
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Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
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| 70 | 2021-01-04 | night sweats |
Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed ...
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Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed us saying that she was feeling sleepy, tired, was having night sweats, and had headaches. Her head felt like someone had put a heavy stone on it. She can still function.
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| 70 | 2021-01-04 | weakness |
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ...
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sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 70 | 2021-01-05 | tremor |
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ...
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severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
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| 70 | 2021-01-06 | discomfort, weakness |
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf...
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Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
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| 70 | 2021-01-07 | pain in extremity |
Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM ...
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Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM feeling achy. I took my temp and it was 98.8F which is a temp for me since I run low, around 96.9F I got ready for work at the hospital and went in. around 0830 my temp was 99.5 and I was more achy and sore. I called Employee Health and they said to continue to monitor my temp and call back if it passes 100. Then around 3PM , my temp was 101.5F I remain very achy and have some occasional ear pain and a mild headache,
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| 70 | 2021-01-08 | flushing |
patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no ...
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patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no swelling throat/face. After calming patient, symptoms subsided. Called Dr. for release/review. 71 y/o female who presents with facial flushing & light headedness that began after her vaccination. No progression or other symptoms. Hx of similar RXN after exercise symptoms. P.E - Mild facial flushing started Possible mild allergic rxn. Plan - home with monitoring.
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| 70 | 2021-01-11 | numbness, facial paralysis |
Facial paralysis; This is a spontaneous report from a contactable Pharmacist. A 70-year-old female...
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Facial paralysis; This is a spontaneous report from a contactable Pharmacist. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899, Expiration Date 30Mar2021), via intramuscular, on 17Dec2020 (at 15:35), at single dose of 0.3 mL for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 70-year-old. Vaccine location was deltoid but unsure which deltoid. The patient did not have a relevant medical history and concomitant medications. Pharmacist said that after vaccination, she waited to be monitored the standard 15 minutes at hospital and then when she got in the car and was on the way home like 20 minutes later she had brief episode of what the patient described as facial paralysis. It was like the side of her face in one area felt funny, it felt numb and it was not anywhere else on her face. It lasted the 20 minutes and then went away. The patient had recovered from the events on 17Dec2020. The pharmacist queried if the patient can proceed with the 2nd dose of the vaccine. The reporting pharmacist considered the event 'facial paralysis' as non-serious.; Sender's Comments: A possible causal relationship between acute onset of facial paralysis and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-01-11 | tingling, feeling jittery, numbness |
Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and...
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Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and felt jittery, lightheaded, sweating, numbness/tingling in both hands, feeling strange
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| 70 | 2021-01-11 | numbness, tingling | sweating, lightheaded, tingling/numbness in both hands, high blood pressure, swollen arm/redness |
| 70 | 2021-01-12 | numbness, tingling |
patient experienced numbness, and tingling in both hands. Stated that is was similar to carpel tunn...
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patient experienced numbness, and tingling in both hands. Stated that is was similar to carpel tunnel syndrome
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| 70 | 2021-01-14 | throat numbness, numbness | Numbness in throat and arm, bp 137/87, 100% oxygen heart rate 72. |
| 70 | 2021-01-17 | flushing |
Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Pa...
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Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Patient was travelling with husband at the car when she experienced warm/hot cheeks, flushing and concerned with history of previous reaction. When patient arrived ( approximately 835pm), patient sat down on the chair. The redness started to extend to her neck and it was then decided to place the patient to the stretcher. Vitals signs were done in which the BP was 183/104 and 174/101 (845pm). The redness spreaded to her forehead and neck. Benadryl 50mg PO was then given (847pm). Patient BP was taken again which was 182/122 , pulse 80, RR 24 (855pm). Patient then complained about pressure in her throat, eyes (right eyes slightly swollen ) and face. It was then decided that epinephrine (859PM) be used but unfortunately the trainer box was removed so the epinephrine was not actually given. The BP documented was then 193/112 (0859PM). EMS was then called as the epinephrine was administered per protocol. EMS arrived (0910 PM) and BP at that time was 230/112, pulse 70. Patient was started with heart monitor and IV. EMS then took her to the Emergency across the street with husband.
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| 70 | 2021-01-19 | tingling | l ARM TINGLING |
| 70 | 2021-01-19 | pain in extremity | sore right arm, took Motrin |
| 70 | 2021-01-20 | weakness, feeling of body temperature change |
I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak...
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I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak. I hurt everywhere. I had a temperature. of 101-102 degrees. My normal temperature is 97.6. I had a severe headache. My vision was impaired. I would go from freezing to being very hot.
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| 70 | 2021-01-20 | tingling, numbness |
Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomi...
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Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
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| 70 | 2021-01-21 | feeling hot, flushing | Flushed hot face and neck, blood pressure 265/117 |
| 70 | 2021-01-24 | tenderness |
3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, r...
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3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-01-24 | feeling of body temperature change, weakness |
She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold a...
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She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold and hot feeling on [her] body; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced delayed symptoms after the first injection of the COVID-19 vaccine, received on 06Jan2021. Patient explained feeling fine the first three days post injection, and later on 09Jan2021 having "chills" and weakness. She then described her experience as "cold and hot feeling on her body". She felt good, her breathing was okay. Her oxygen and everything was okay. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-01-25 | weakness |
Patient self-reporting through the hospital's electronic reporting system. In her own words, "Recei...
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Patient self-reporting through the hospital's electronic reporting system. In her own words, "Received 2nd Pfizer COVID-19 Vaccine. Beginning 17 hours later, I had extreme weakness, headache, chills and fever. I had to take off Friday, January 22, 2021, from work because of not feeling well. I still am not feeling well".
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| 70 | 2021-01-25 | pain in extremity |
entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her s...
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entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her soreness/aching is mainly in her back, arms left deltoid, and legs/sore arm from the injection; Her soreness/aching is mainly in her back, arms left deltoid, and legs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure, ongoing eye disorder, high cholesterol, and overweight. Concomitant medications included amlodipine, losartan, and metoprolol all from 2003 and ongoing for high blood pressure; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) for the eyes; and medication for high cholesterol. At night of 11Jan2021, the patient's entire body felt sore. Her soreness/aching is mainly in her back, arms left deltoid, and legs. She had a sore arm from the injection which started immediately. Outcome of the "entire body felt sore" and "soreness/aching in her arms left deltoid/sore arm from the injection" was not recovered while of the remaining events was unknown.
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| 70 | 2021-01-27 | pain in extremity |
Red spot where I had the vaccine and it was itchy; Red spot where I had the vaccine and it was itchy...
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Red spot where I had the vaccine and it was itchy; Red spot where I had the vaccine and it was itchy; it still hurts and when I touch it; Pain on my arm; Rash; I do feel like a little bit of a bump; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing thyroid disorder (Verbatim: Don't have a thyroid). Concomitant medication included ongoing levothyroxine for thyroid disorder. The patient stated on 16Jan2021, "I had the COVID Vaccine on the 14th (14Jan2021). I had just pain on my arm, no side effects. But today I noticed that I had a red spot where I had the vaccine and it was itchy, so I had, but it is mild. It is nothing that's all over me, I have got a rash or anything. Just on the side it looks little red and itches and it still hurts and when I touch it, I do feel like a little bit of a bump, little bit. Is this an allergic reaction and therefore for my second dosage, will that be may not react or what?" Clinical outcome of the events was unknown.
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| 70 | 2021-01-28 | pain in extremity |
Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontan...
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Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
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| 70 | 2021-01-28 | tingling |
Reports feeling tingling on her fingers, both hands. She was evaluated by Fire department and relea...
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Reports feeling tingling on her fingers, both hands. She was evaluated by Fire department and released home feeling better at 2:10 pm.
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| 70 | 2021-01-28 | pain in extremity |
by 1700 same day - lots of pain in 4rd digit on flexion and extension 8/10 - thought it was her kn...
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by 1700 same day - lots of pain in 4rd digit on flexion and extension 8/10 - thought it was her knuckle at first - couldn't grip or extend finger; now better - pain 5/10 - now can extend and grip - may be medial nerve irritation digits 3, 4, 5 a little painful but not like 4th digit slight shoulder pain at injection site
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| 70 | 2021-01-29 | weakness |
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ...
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Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
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| 70 | 2021-01-29 | feeling hot |
Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-...
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Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-8 minutes after the vaccine administration. Patient denies any difficulty in breathing. Patient is drinking some juice- describes the feeling of her throat feeling scratchy. 1035 VS- HR-52, 96% RA, 132/76. At 1048 patient reports that she feels better and the symptoms have gone away and she feels the same as she did when she came into have her vaccine. Patient will continue to wait a full 30 minutes after beginning of being checked out. 1100- patient reports again feeling the same as she did when she walked in and feels ok to leave.
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| 70 | 2021-01-30 | feeling hot, feeling jittery |
12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight ...
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12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight feverish feeling slight nausea,, which lasted ...then just turned into flu like feeling...insomnia with body feeling slightly jittery till 4am ,took nighttime cold tablet. Flu like symptoms till 31st am.
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| 70 | 2021-01-31 | weakness |
Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling ...
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Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.
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| 70 | 2021-01-31 | one side paralysis |
Resident was noted on 1/25 with an increased functional decline as she would not feed herself with u...
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Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils, but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21, unremarkable for CBC and CMP. 75,000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive, taking meds, and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date.
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| 70 | 2021-02-01 | tingling, numbness |
Bad taste in mouth; numbness and tingling on right side of face; numbness and tingling on right side...
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Bad taste in mouth; numbness and tingling on right side of face; numbness and tingling on right side of face; swollen area near jaw line; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (pregnant: No) received first dose of bnt162b2, via an unspecified route of administration in right arm on 19Jan2021 11:00 at single dose for covid-19 immunization. Medical history included cardiac patient, iodine allergy from an unknown date and unknown if ongoing. Concomitant medication included prednisone, clopidogrel bisulfate (PLAVIX), lisinopril. The patient experienced bad taste in mouth, numbness and tingling on right side of face, swollen area near jaw line on 19Jan2021 with outcome of recovering. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No other vaccine in four weeks. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch has been requested.
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| 70 | 2021-02-01 | pain in extremity, tingling, burning sensation |
Fever, headache, general achy. Than suddenly six days later intense burning, tingling, painful feeli...
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Fever, headache, general achy. Than suddenly six days later intense burning, tingling, painful feeling in both legs and feet with weakness in both legs
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| 70 | 2021-02-01 | feeling hot |
I was at RCSJ-Meg After 15-20 minutes my vision blurred, I had bad headache, felt very hot, somewhat...
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I was at RCSJ-Meg After 15-20 minutes my vision blurred, I had bad headache, felt very hot, somewhat dizzy and tired. I sat for 45 minutes until I felt better. Vision cleared, headache disappeared after 15-20 minutes thereafter .. I iced my arm when I came home, and fell asleep for a few hours.
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| 70 | 2021-02-01 | pain in extremity |
Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, ...
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Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.
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| 70 | 2021-02-01 | pain in extremity, weakness |
arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be he...
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arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be helped to the bathroom); very weak; not feeling well; very sick; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 70-year-old. Medical history included Sars-Cov-2 infection (Mar2020), sick for 5 or 6 days, who knowingly has antibodies, and has donated plasma on multiple occasions, asthma but does not report respiratory symptoms, mild hypertension, migraines, vascular problems, and chronic portal vein thrombosis (PVT). Concomitant medications included linaclotide (LINZESS), hydrochlorothiazide, rosuvastatin, montelukast, levothyroxine, clopidogrel. On 13Jan2021 at night, she reports arm soreness/arm hurt, and that when she woke up the next day she 'felt like she had Covid all over again' with: headache, swollen glands, head 'felt stuffy', very weak muscles (had to be helped to the bathroom), no fever but caller did state that she took a Tylenol. From Wednesday to Saturday she didn't feeling well, but every day she felt a little better. She has asthma - drug out my peak flow meter (as reported). No asthma sx during this whole thing. She reported adverse events and thinks some might have been stunted by the Tylenol she took after the first dose. She reported she was very sick, she still had like waves of not feeling well. She had most of the symptoms that she had was when she had Covid. She was sick, she was in bed and could not move. The most severe symptoms were on 13th and slowly each day felt better and it was until Saturday was when she really started to feel a 100 percent herself. Events were reported as non-serious. She had recently lab test within the last month or so. She had two or one and blood and everything was negative, everything was normal. Outcome of very sick and not feeling well is not recovered, while the outcome of the other events is recovering. She should receive the second dose on 02Feb2021. Information about lot/batch number has been requested.
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| 70 | 2021-02-02 | muscle spasms |
Next day after shot-I have herpes and my mouth, tongue and genitals were broke out with blisters the...
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Next day after shot-I have herpes and my mouth, tongue and genitals were broke out with blisters the worse I have ever had and bad cramps-still having the cramps that go with it a week later. Worried about having the 2nd shot-my husband passed a yr. ago and I am alone.
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| 70 | 2021-02-03 | pain in extremity |
arm has been sore; looked like she had a sunburn all over her body/sunburn looking skin felt like he...
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arm has been sore; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccination site: left, almost her shoulder) on 14Jan2021 13:45 as COVID vaccine. The vaccine was administered at clinic. Vaccine not administered at military facility. There were no concomitant medications. Patient had no prior Vaccinations (within 4 weeks). The patient previously took acetylsalicylic acid (ASPIRIN), ibuprofen and NSAIDS wherein she was allergic. This was years and years ago. When she took the products, she had silver dollar size hives from head to toe. Patient asked if there was any of this in the vaccine. The patient previously got shingles vaccine on 2019 (2 years ago) at the pharmacy wherein she had a sore arm and a bruise. The patient had no other relevant history. Patient reported she just got home from the emergency room. It was explained that on 14Jan2021 (yesterday) she got the vaccine. On 15Jan2021, her arm had been sore today since getting up but about 1pm today she looked like she had a sunburn all over her body. Her husband gave her 2 diphenhydramine (BENADRYL) and rushed her to the emergency room. They told her that they can't say for sure but that was likely that it was caused by the vaccine. The soreness was about the same. Looking like she had a sunburn all over her body, that was gone. The patient further explained the sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on. There have been no other treatments. She remarks she had to wait so long in the emergency room by the time they saw her it had resolved. Investigation assessment/relevant tests were not performed. The emergency room told her the Benadryl likely knocked it out. They offered Tylenol and an IV but she declined; she felt there was no reason since she was doing better. She was told to take 2 more diphenhydramine 25mg in 6 hours. No physician office visit required for the events. She was supposed to get the second dose on 04Feb2021 but was told to ask if she should still get it. The outcome of arm has been sore was not recovered, while other events recovered on 15Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
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| 70 | 2021-02-03 | speech disorder, burning sensation |
bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl a...
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bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.
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| 70 | 2021-02-03 | burning sensation, tingling |
feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from ...
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feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 12Jan2021, and she has had a serious reaction since; she felt itchy, burning, tingling and paresthesia all over her body. She has been on Benadryl for it. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events itchy, burning sensation, paresthesia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-02-04 | weakness |
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakn...
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Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
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| 70 | 2021-02-04 | tingling, face paralysis |
c/o tingling starting 1 hour ago on left side of her face. She received a Pfizer COVID 19 vaccine, w...
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c/o tingling starting 1 hour ago on left side of her face. She received a Pfizer COVID 19 vaccine, was watched for 15 minutes, went home in stable condition. Later noted a tingling sensation in her left side of the face and throat, she denies any other weakness, no difficulty speaking or walking.
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| 70 | 2021-02-05 | pain in extremity |
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,...
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My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
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| 70 | 2021-02-05 | flushing | Severe headache, face flushing, swollen tongue, throat closing off |
| 70 | 2021-02-05 | tremor, feeling hot, feeling cold |
Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By ...
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Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched. Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed. Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax. This continued for a few hours. By morning, I thought I was starting to feel better. These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm. On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees. This resolves after about an hour and body feels normal.
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| 70 | 2021-02-06 | tremor, weakness | Fever 103, shakes, chills, profound weakness, loss of appetite, high blood sugar |
| 70 | 2021-02-06 | migraine |
Fever, chills, sinus congestion, extreme fatigue, general body aches. Followed by migraine. Sympto...
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Fever, chills, sinus congestion, extreme fatigue, general body aches. Followed by migraine. Symptoms residing 24 hours later
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| 70 | 2021-02-06 | hypersensitivity of all senses |
On days 4-7 post injection, I experienced facial nerve pain that felt like herpes or shingles includ...
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On days 4-7 post injection, I experienced facial nerve pain that felt like herpes or shingles including ear pain, cheek hypersensitivity, swollen gland in neck, and sores along the bottom left gum line in my mouth. This all occurred on the right side of my face. I did not treat the pain or eruptions in any way except for regular dental care. The symptoms healed/subsided after 5 days . I have a small amount of residual sensation in my jaw near my ear but it is much better.
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| 70 | 2021-02-06 | pain in extremity |
Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral met...
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Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral meta-tarsal pain on hands (which I used to have as part of my osteopenia. But was symptomless for a while). After about 18 to 20 hours after vaccination experienced severe bilateral metatarsal pain and joint pain on knees and back. Mild to moderate nasal congestion. Took 1 gram APAP /Benadryl alternating with ASA 325mg along with bedrest. Over the course of 2 days the pain (myalgia and arthralgia), flu-like symptoms and congestion resolved.
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| 70 | 2021-02-06 | pain in extremity | Sore Arm X 8 hours |
| 70 | 2021-02-06 | feeling hot |
after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling ...
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after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling numb and tingly, was taken to ER as it was part of the same building in a wheel chair, was also anxious, nauseated and had dry heaves and blood pressure was elevated. Received IV solumedrol, ativan and zofran and then later oral benadryl. I was told to contact my PCP to see if I should get the second vaccine and he indicated no.
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| 70 | 2021-02-07 | tremor |
chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-y...
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chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 21Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, Acid reflux, urinary tract. Concomitant medication included enalapril (ENALAPRIL) for Blood pressure, omeprazole (OMEPRAZOLE) for Acid reflux, and took another pill (Unspecified Medication) for urinary tract (Not clarified), 10 mg a day. The consumer reported she had the COVID vaccine 22Jan2021 11:00, was great all day, had no reaction, felt fine, ate, was active and then about 8:15 at night all of a sudden, she started to get the shakes and the chills and was feverish and she guessed it was an adverse reaction to the vaccine or side effect she did not know. Right now she was normal, slept okay but she was just wondering was this a normal. She took 2 Tylenol every night 4-5 hours, 500 mg took 2. The consumer meaned they don't even say this on the form if you get this reaction what you could take so she took it myself and it did help, the fever reducer. The patient underwent lab tests and procedures which included body height was 5 foot 5 and a quarter on an unknown date; body temperature was 101.2 on 21Jan2021, and 98.6 in Jan2021, Swab test on Tuesday (unknown date) with unknown result, didn't get the result yet. The event outcome was recovered in Jan2021.
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| 70 | 2021-02-08 | tingling, numbness | Headache, Fatigue, Tingling & Numbness, Tightness in upper chest 11:20am-4pm |
| 70 | 2021-02-08 | bell's palsy |
On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and w...
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On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and was diagnosed with Bell's Palsy.
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| 70 | 2021-02-08 | breast pain | Swollen lymph nodes and breast pain. Only lasted the day. |
| 70 | 2021-02-08 | pain in extremity | Vomiting, diarrhea, chills, fog head, tiredness, slight sore arm |
| 70 | 2021-02-08 | feeling of body temperature change |
about 5 hrs after injection started to get headaches, during the night i felt really hot but then i ...
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about 5 hrs after injection started to get headaches, during the night i felt really hot but then i had to get extra blankets because i was freezing. Then when i woke up i had Muscle pain. Then i started throughout day i started Sneezing, watering up, coughing, runny nose. muscle pain is getting better but still have the other symptoms
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| 70 | 2021-02-09 | tremor, pain in extremity |
Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tre...
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Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tremors in her hands/hands started shaking non-stop; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 21Jan2021 at 10:40 at single dose for COVID-19 immunization. The relevant medical history included asthma, tremor (Tremors that runs on her mother's side of the family), neuropathy of hands and arms, high cholesterol, thyroid, neuropathy, vascular gait disorder, cervical stenosis operation from 2018. Concomitant medications included painkiller for neuropathy and unspecified medicines for high cholesterol, thyroid. She stated she received the first dose on 21Jan2021 and experienced tremors in her hands starting the following day. She stated that Friday her hands started shaking non-stop and had done that since then. She also reported having a sore arm. She had occasional tremors that didn't last very long. Since COVID-19 Vaccine had had nonstop shaking of hands since around Friday. Primary care doctor didn't treat her. Went to a pain center and neurologist. No further details provided. Tried to report online, but there were too many questions so she opted out. Does kind of get better if she is real still and lays down, but it still shakes. Never had this before. The patient stated that Friday or Saturday she didn't remember exactly when, sometimes they shake but not very long but this was like nonstop and it's a much more aggressive shaking. She hoped she could get the second one because she wanted the protection. She was not sure of her weight because she lost a bunch when she had surgery but she was about 115. When probed for treatment, she stated that it went away it was a day or so after but the hands were shaking and it's very intense shaking and it's going on and it's not stopping. She didn't have anything for it. It's never been like this before. The outcome of the event tremors in her hands/hands started shaking non-stop was not recovered, while other events were unknown. Information about lot/batch number has been requested.
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| 70 | 2021-02-09 | weakness |
face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weaknes...
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face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-02-09 | migraine |
light sensivity. Light hurts my eyes almost like migraine; migraine; This is a spontaneous report fr...
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light sensivity. Light hurts my eyes almost like migraine; migraine; This is a spontaneous report from a contactable consumer reported that a 70-year-old female patient (consumer) (non-pregnant) received BNT162B2 (Solution for injection, lot number: El3249) on 27Jan2021 at 11: 00 AM in single dose for Left arm, dose number: 2, for covid-19 immunization. Patient medical history included Controlled BP, cholesterol, thyroid, known allergies: sulfa drugs. Patient previously took cimetidine sodium alginate (TAGAMET) and had Tagamet allergy, tetracycline and had tetracycline allergy, Iodine and had Iodine allergy. Historical vaccine included BNT162B2 on 06Jan2021 at 11:00AM (lot number=EK9231, vaccine location=Left arm, dose number=1) for covid-19 immunization. Concomitant medications were not reported. On 28Jan2021, at 08:00AM, patient had light sensitivity and Light hurts my eyes almost like migraine. If this was still like this Monday she will go to doctor. No treatment was received for adverse event. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was not recovered.
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| 70 | 2021-02-10 | feeling cold |
Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8 Thurs 2/4 & continui...
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Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8 Thurs 2/4 & continuing thru Thurs 2/11
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| 70 | 2021-02-11 | weakness |
Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minute...
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Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minutes), Weak leg, (briefly, Aching, Dry eyes even with home humidifier on furnace, ribs hurt for about 5 min. and wheezing upon awakening at 4:45am, most symptoms gone by about 7:30am, Thursday.
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| 70 | 2021-02-11 | feeling hot, facial paralysis, tremor |
blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumpin...
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blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
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| 70 | 2021-02-11 | pain in extremity | low grade fever for 12 hours, body aches, sore arm |
| 70 | 2021-02-14 | muscle spasms, muscle twitching, weakness |
Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior t...
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Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior to above diarrhea & vomiting. Muscle cramping & muscle twitching much like electrical shock especially in lower extremities along with severe headache. Low grade fever & mild chills. Extreme tiredness/low energy which still remains. There was also a degree of dizziness which remains as well.
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| 70 | 2021-02-14 | weakness |
Patient feeling sweaty and weak.. History of DM and HTN. Did not take meds this morning. BP- 195/92...
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Patient feeling sweaty and weak.. History of DM and HTN. Did not take meds this morning. BP- 195/92, after 2 minutes 199/101, after 5 minutes- 179/101 Monitored and released to home after 30 minutes. Will take BP meds when gets home and follow up with primary MD
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| 70 | 2021-02-14 | weakness |
Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in ras...
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Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in rash around eyes and rash on hand. Patient reported symptoms lasted over a week. Went to ED, given IV fluids and discharged home.
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| 70 | 2021-02-14 | pain in extremity |
Sore arm w/in 2 hours. Lasted 24 hrs Fatigue, w/in 2 hours, lasted 24 hrs Muscle aches, began in 1...
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Sore arm w/in 2 hours. Lasted 24 hrs Fatigue, w/in 2 hours, lasted 24 hrs Muscle aches, began in 12 hrs, lasted 12 Headache, began in 12 hrs, lasted 6
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| 70 | 2021-02-15 | tremor |
1318; patient c/o palpitations& SOA. Trembling to B UE. pt showing "EKG" result from apple watch t...
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1318; patient c/o palpitations& SOA. Trembling to B UE. pt showing "EKG" result from apple watch that she describes as "afib". Denies need to be seen in ED PB 197/102, HR 62, SpO2 98%; 1325; BP 174/85, HR 65, SpO2 98%; 1334; BP 138/84, HR 65, SpO2 98%
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| 70 | 2021-02-15 | burning sensation | Itching, burning, red, swollen hands and feet. |
| 70 | 2021-02-15 | pain in extremity |
Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DV...
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Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DVT No history of blood clots, no prior risk factors Cannot be certain that she did not have clot prior to vaccine, although she never had pain or swelling to this degree (1-2 mo prior thought skinny jeans were slightly tighter on R than L, but no visible swelling. Now with RLE 2x size LLE)
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| 70 | 2021-02-15 | pain in extremity |
Right arm became very sore 2 hours after vaccination. But no rash or swelling. Soreness gradually g...
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Right arm became very sore 2 hours after vaccination. But no rash or swelling. Soreness gradually got better over 4 days, but soreness returned 1 week after vaccination and has persisted to current time which is almost 3 weeks since receiving shot. Interferes with sleep. Tylenol helps. Still no swelling or rash.
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| 70 | 2021-02-16 | cold sweat, tingling |
01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tinglin...
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01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tingling. Assessed & noted p - 109, O2 sat 97%, skin warm / clammy with no discoloration at left upper arm injection site. Allergies verified and noted as Sulfur, Levaquin and PCN. Participant remained sitting and encouraged to deep breathe. At 1518 B/P 153/100, HR 102, O2 sat 98% with continued c/o. EMS activated at 1518 and pt moved to monitoring area; declined lying down, sat in chair for care. Post move to chair O2 sat drop to 90% then returned to 96%, HR 111. 1522 Administered Benadryl 50 mg IM right upper arm with no resp distress / rash noted. At 1554 participant voiced feeling better already with arrival of EMS noted
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| 70 | 2021-02-16 | breast pain | Soreness and tenderness in breast. |
| 70 | 2021-02-17 | flushing |
Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did ...
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Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did not know how to use epi-pen. I used my own epi- pen, ENT used heart monitor, intervenious Benadryl was administered, I was transport to ER at hospital, treatment with more meds, prednisone. I was kept in ER for several hours for monitoring. I had no more reaction.Y
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| 70 | 2021-02-18 | flushing |
10 minutes after receiving her first dose of Covid vaccine, patient felt dry, itchy throat and had a...
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10 minutes after receiving her first dose of Covid vaccine, patient felt dry, itchy throat and had a dry cough. She was brought to us by EMS staff for medical evaluation. BP was elevated. Denies any other symptoms. Face slightly flushed, chest CTA, RRR, able to communicate well, A&O. BP 184/115 left arm, repeat after 10 minutes: 164/102. has hypertension and took her med today. Symptoms resolving and after approx 20 minutes, completely resolved. Patient declines to be transferred to local healthcare facility and agreed to call her PCP once she returned home to notify of BP and possible reaction to vaccine. Feeling much better, she stated her husband was here and she was going home.
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| 70 | 2021-02-18 | feeling hot |
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in...
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Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-18 | feeling hot |
I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have r...
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I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have rapid heartbeat, anxiety and felt warm. The nurse checked my breathing and checked for rashes and said it was not an anaphylactic reaction. Symptoms subsided after 5 or so minutes and I went home and have not had further side effects. But my question is, should I get my second shot in 3 weeks?
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| 70 | 2021-02-18 | pain in extremity |
Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. ...
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Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. 19th).
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| 70 | 2021-02-18 | pain in extremity |
redness, pain , swelling and warmth at site that progressed over several days. became painful to li...
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redness, pain , swelling and warmth at site that progressed over several days. became painful to lift left arm. treated with antibiotic (keflex 500 tid for 10 d) and medrol dose pack, zyrtec and famotadine 40 at night
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| 70 | 2021-02-21 | migraine |
27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature wen...
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27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature went up to 100.8. My chest was tight and achy and my oxygen levels stayed at about 88. I slept about 10 hours and woke up feeling fine. My chest is sore and achy but better than yesterday.
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| 70 | 2021-02-21 | pain in extremity | Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes |
| 70 | 2021-02-21 | weakness |
Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took ace...
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Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen and some anti -nausea drugs I had on hand. Fever left, but returned next night. Weakness, no appetite stayed for two days. Thought it was the flu, but no upper respiratory symptoms. Thought it might be Covid-19 but tested negative. Finally decided it was a reaction to the vaccine.
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| 70 | 2021-02-22 | unresponsive to stimuli, discomfort, feeling cold, cold extremities |
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g...
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2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
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| 70 | 2021-02-22 | pain in extremity, tenderness |
A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bu...
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A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bump is getting larger in size.
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| 70 | 2021-02-22 | feeling hot |
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. ...
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I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
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| 70 | 2021-02-22 | burning sensation, feeling hot |
Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started...
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Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl.
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| 70 | 2021-02-22 | hot flush |
The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while ...
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The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while also having a slight headache. The feeling went away after 10 minutes and began 15 minutes after receiving her second Pfizer vaccine dose.
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| 70 | 2021-02-22 | pain in extremity |
When I left facility I had a mild headache. After getting on the highway face turned beet red with ...
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When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
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| 70 | 2021-02-22 | tremor, pain in extremity |
pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the ...
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pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
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| 70 | 2021-02-23 | tremor, feeling cold |
A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizur...
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A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizure because my lack of control was evident in my movements. With my heaviest PJs on, it took 8 blankets to finally warm me up. I am on a CPAP machine but I was having a hard time getting my breath. I was also nauseous but never threw up. I finally got back asleep a little after 3 am but woke several times after that. This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy. It is now 2 pm and I just want this to be over. On the first shot, I didn't have any reaction at all.
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| 70 | 2021-02-23 | weakness | Body aches, felt feverish, weakness, headache, fatigue, overall malaise |
| 70 | 2021-02-23 | difficulty speaking |
Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Lo...
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Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.
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| 70 | 2021-02-23 | weakness |
Pt. from tent 3 at observation lane was complaining of light headedness + generalized weakness. Par...
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Pt. from tent 3 at observation lane was complaining of light headedness + generalized weakness. Paramedics assessed. Once symptoms subsided paramedics released pt. to leave.
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| 70 | 2021-02-23 | pain in extremity | Sore arm....48 hours |
| 70 | 2021-02-23 | tremor, weakness, pain in extremity |
arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then al...
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arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then also and found swelling like an orange, swelling lasted 8 days but was decreasing in size. became very cold and went into violent shaking tremors - 4-6 of those as i lost count. these violent tremors were from 10:30 pm on monday through 1:45 am tuesday. i had one other tremor on day 4. fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3, severe all over body aching especially right armpit, lower back especially right side and across shoulders, aching lasted 8/9 days and lessened after 5 days. pressure on chest which ranged from very heavy to mild and in some form lasted 10 days, hurt to breath but i could breath. woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours. nasty headache began day 2 and lasted several days; nothing relieved it. headache for 4/5 days and then off and on for a few days. i am not prone to headaches. coughing which lasted several days. on third day post vaccine had violent nausea one time. became weak and lightheaded. no energy and stayed in bed 5 days. on day six i started getting out of bed for several hours multiple times/day. weak and very low energy. exhausted easily. i had some of these symptoms for 10 days. the first 5 days were terrible and i was very ill.
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| 70 | 2021-02-23 | pain in extremity, feeling cold, tremor |
extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then ...
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extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then walked to parking garage. Breathing became labored as I walked the block to car - no one was around. Pulled off mask and sat in car - it subsided in 15 minutes. Body temp was 94.5 remainder of the day. 96.5 today. Awoke nauseated, headache, left foot and hand pain and very sore left arm. Nausea stopped about 3:00 pm, when body tremors started again. Cold all day with no energy
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| 70 | 2021-02-23 | flushing |
flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, ...
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flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, light rash arms, and trunk; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jan2021 01:00 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to receiving bnt162b2. The patient was not diagnosed with covid prior to vaccination. The patient was not pregnant. Medical history included allergies to tree nuts, bees, penicillin, and sulfa. Concomitant medications were included hormones, fluticasone propionate, salmeterol xinafoate (ADVAIR), and esomeprazole sodium (NEXIUM). The patient experienced flushing of face within 10 minutes (as reported), light rash arms, and trunk on 23Jan2021 01:15 PM (as reported). The patient was not tested for covid post-vaccination. The patient received Benadryl as a corrective treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
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| 70 | 2021-02-23 | feeling cold |
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to...
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nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-24 | feeling hot |
Patient felt hot and given a cold pack. State throat symptoms similar to Phenergan reaction. Subsi...
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Patient felt hot and given a cold pack. State throat symptoms similar to Phenergan reaction. Subsided after a couple of minutes. Observed for 30 minutes and released.
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| 70 | 2021-02-24 | seizure like phenomena, speech disorder, unresponsive to stimuli |
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vacci...
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Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department. Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
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| 70 | 2021-02-24 | hot flush |
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face beco...
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Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
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| 70 | 2021-02-25 | weakness, numbness |
Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of ...
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Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of tongue Chills, weakness, headache, blurred vision for a short time Took Benadryl on my own, continued taking non drowsy Claritin 5 days after shot feeling better. Still have slight numbness in my lips and feeling weak
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| 70 | 2021-02-25 | pain in extremity |
Severe pain in left shoulder and left arm. It felt like I had ripped a muscle or tendon and would h...
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Severe pain in left shoulder and left arm. It felt like I had ripped a muscle or tendon and would hurt constantly. Pain scale of 7-9 all day and night for a week. Daly?s 6& 7 the pain did subside slightly and remain d light pain for two more days
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| 70 | 2021-02-25 | pain in extremity |
fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report...
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fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
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| 70 | 2021-02-26 | tingling | Anxiety and tingling |
| 70 | 2021-02-26 | flushing, involuntary muscle movements |
EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face withi...
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EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face within 15 min of receiving the COVID vaccine (Pfizer, lot #EN6202, expiration date 6/30/2021, dose 1). EMT approached client, asked how she was feeling, client reported feeling fine. At 1337 EMT took oxygen saturation 98% and pulse 96. EMT informed PHN of client's condition and possible language barrier. EMT stayed with client as PHN called over client's family member who was waiting outside. Family member used FaceTime to call client's daughter for help with translation. Per client's daughter, client suffers from anxiety, asthma, hypertension and hyperlipidemia. EMT took vital signs: blood pressure 140/Palpated, respiratory rate 24, oxygen saturation 97%, pulse 96. Client's list of medications: diltiazem, clopidogrel, atorvastatin, Montelukast, albuterol sulfate, incruise Ellipta, flucatisone propionate, vitamin D, famotidine, benzonatate, losartan, gabapentin, duloxetine, prednisone, and vitamin C. Client's daughter translated and reported that client felt anxious, warm, and had difficulty breathing similar to her asthma flares. PHN noted client's arm was warm to touch, face flushed, anxious movement as noted by repeated touching chest and face, no use of accessory muscles noted. At 1346, vital signs: oxygen saturation 95%, pulse 92, blood pressure 138/70, respiratory rate 24. At 1350, PHN offered client benadryl, client consented and took 2 capsules of benadryl (50mg dose) orally. At 1352, client moved to chair outside on patio in front of CWS in the shade as offered by PHN, gait steady and assisted by family member. At 1352, client signaled to family member that she felt better, PHN noted decreased flushing, posture relaxed with arms at sides while sitting in chair outside. At 1402, PHN advised client and family member to have client follow up with PCP within 24hrs or as soon as possible thereafter. At 1413, vital signs: oxygen saturation 96%, pulse, 84, blood pressure 140/90, respiratory rate 16. PHN noted client yawning, no redness noted in face, no longer warm to touch at 1415. At 1427 vital signs: oxygen saturation 97%, pulse 85, blood pressure 140/100, respiratory rate 16; PHN advised to call 911 if adverse reaction occurs. At 1430, client left, gait steady, with family member to the car. Family member drove.
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| 70 | 2021-02-26 | pain in extremity |
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat...
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Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
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| 70 | 2021-02-27 | numbness, muscle twitching, weakness |
Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf ...
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Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf muscle and arms, itchy feeling under the skin, symptoms lasted 4-5 days, improved with Benadryl,
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| 70 | 2021-02-28 | hot flush, pain in extremity |
2-22 6PM extremely sore left arm 2-22 9PM could not move left arm up but about 8" 2-23 10AM-...
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2-22 6PM extremely sore left arm 2-22 9PM could not move left arm up but about 8" 2-23 10AM-12PM Flushed hot to touch cheeks-normal temperature 2-24 9AM rash on left underarm....had scratched during the night & arm sore to touch in that area 2-25 9AM rash had subsided but arm still sore to touch
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| 70 | 2021-02-28 | pain in extremity |
Generalized pain that started on the extremities and has moved to the spineal column. Symptoms were ...
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Generalized pain that started on the extremities and has moved to the spineal column. Symptoms were present prior to vaccine but have worsened. Started roughly 3 days post vaccination. OTC pain medication lessens symptoms. Pain is constant and randomly spikes.
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| 70 | 2021-02-28 | flushing |
hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, v...
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hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, vomiting, chills--resolved after 9 hours
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| 70 | 2021-02-28 | numbness, pain in extremity |
nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she...
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nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she has a cough in her throat; swelling and soreness of her arm; swelling and soreness of her arm; Tightness in her jaw; Numbness in hand; difficulty swallowing; taste in her mouth; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in left arm on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization in a clinic. Medical history included ongoing underactive thyroid, cataract surgery on 14Oct2020 and on 28Oct2020, and cholesterol (abnormal). Concomitant medications included ongoing levothyroxine for underactive thyroid and ongoing rosuvastatin calcium for cholesterol. The patient experienced nervousness, slight swelling/tingling in lips, dizziness, like she has a cough in her throat, swelling and soreness of her arm, tightness in her jaw, numbness in hand on 26Jan2021. The patient also had difficulty swallowing, had taste in her mouth, and dry mouth in Jan2021. The patient on the line calling about the COVID-19 vaccine. She got the shot yesterday (26Jan2021) and was calling to report on the reaction that occurred. She initially stated she had slight swelling/tingling in lips, difficulty swallowing, numbness in hands, jaws became tight, and nervousness which she is still experiencing. She mentioned she took benadryl. She was wondering if she should go and get the second shot. The patient first experienced dizziness which lasted for a second and this occurred while waiting in the lobby for observation after getting the vaccine. Slight swelling and tingling in lips were noticed two minutes after the dizziness. It felt like a tingle sensation. She clarified she does not necessarily have difficulty swallowing. It was not so much she could not swallow, but it was like she has a cough in her throat. It feels like she could cough but would need to keep swallowing and drinking water. Once she got the shot it caused her to get a taste in her mouth. The feeling like a cough in her throat has gone away, but now she feels nervousness, dry mouth, and she still has that taste in her mouth from getting the shot. She had swelling and soreness of her arm, but she knew that was to be expected which started an hour after getting the vaccine. Tightness in her jaw was noticed an hour after getting the vaccine. The numbness in hand started at the same time as the tightness of her jaw. Her left hand is what went numb, and she had the vaccine administered in her left arm. The nervousness is getting better, but she felt very nervous. She also mentioned she has thyroid problems and is not sure if this has anything to do with it. She had this nervousness feeling 2 hours after getting the shot. Patient is scheduled to get the second vaccine on 18Feb2021. Benadryl has helped a lot. The patient has no additional vaccines administered on the same date and has no prior vaccination within four weeks. The events did not require emergency room and physician office visit. Vaccine was not administered in a military facility. The patient was recovering from events nervousness, slight swelling/tingling in lips, swelling and soreness of her arm, tightness in her jaw, and numbness in hand; recovered from dizziness on 26Jan2021; recovered from event "like she has a cough in her throat" on unspecified date; not yet recovered from event "taste in her mouth"; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-01 | weakness |
Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let...
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Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let us drive off the site) I stopped by a convenience store to pick up a bottle of water. Severe Headache -started about 30 mins later along with tiredness and chills. Headache subsided after a few hours and then experienced extreme muscle pain in my neck and shoulders along with a feeling of malaise. Did not take any OTC drugs. Layed down in bed and tried to sleep.
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| 70 | 2021-03-01 | pain in extremity |
Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwar...
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Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwards for almost 12 hrs. Thereafter, symptoms gone other than fatigue and sore arm.
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| 70 | 2021-03-01 | pain in extremity |
received dose 1 of Pfizer at SFS on 2/12/2021, dose 2 scheduled for 3/5/2021 which is 21 days later,...
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received dose 1 of Pfizer at SFS on 2/12/2021, dose 2 scheduled for 3/5/2021 which is 21 days later, but he returned one week early by mistake and received dose 2 on 2/26/2021 instead of on 3/5/2021 No one at Stadium caught it that he was a week early for dose 2 when he checked in, and no one caught it when they signed his vaccine card for the second time. The patient experienced a sore arm for one day after dose 2, but no other vaccine side effects.
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| 70 | 2021-03-02 | sensory loss |
Patient reported loss of sensation in arm 4 days following vaccine administration. Reported to pharm...
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Patient reported loss of sensation in arm 4 days following vaccine administration. Reported to pharmacy 2 days following symptom onset. Patient reported feeling has improved since onset.
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| 70 | 2021-03-02 | seizure |
Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that ...
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Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine, and later that evening experienced a seizure and expired.
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| 70 | 2021-03-02 | burning sensation, pain in extremity |
Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then rad...
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Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then radiated across her shoulders. Pt has wheezing which she reports is normal for her. BP is elevated, pt reporting not taking her meds this a.m. MD ordered breathing treatment of albuterol and metoprolol 50mg po for BP of 175/101. HR 68 SR 100%SpO2/RA,RR=21, No Respiratory Distress Noted
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| 70 | 2021-03-02 | cold extremities |
Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken,...
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Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken, initial BP 186/87, P 65, PO2 100%. Pt said BP was extremely high for her. F/U BP = 194/84. Pt was subsequently assessed by MD, who knew pt as a PCP. Reported elevated BPs for pt in past, but not that high. Next BP 202/97. Pt then went to the bathroom, took a walk outside. Came back, manual BP 160/89, coldness in feet resolved. Pt was started on amlodipine 2.5 mg PO daily, to f/u with PCP in 2 weeks.
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| 70 | 2021-03-02 | flushing |
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size...
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all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-02 | weakness, facial pain, pain in extremity |
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri...
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fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
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| 70 | 2021-03-02 | feeling hot |
pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable n...
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pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EM9810) via intramuscular in the left arm on 10Feb2021 13:15 at single dose for covid-19 immunisation. Medical history included hypothyroid. Known- allergies included sulfamethoxazole; trimethoprim (BACTRIM). Concomitant medication included levothyroxine, tramadol, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced pain at injection site, swelling, warmth, redness; all on 12Feb2021 08:00. The events resulted in physician office visit. The patient was hospitalized from Feb2021 for the events. Treatment received for the events included cefalexin (CEPHALEXIN) orally; methylprednisolone (MEDROL) dose pack; famotidine; and cetirizine hydrochloride (ZYRTEC). The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-03-02 | weakness |
she experienced dizziness and weakness; she experienced dizziness and weakness; This is a spontaneou...
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she experienced dizziness and weakness; she experienced dizziness and weakness; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262, expiry: May2021), via an unspecified route of administration (at the age of 70years) on 27Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension and Crohn's. Concomitant medications included lisinopril, estradiol, levothyroxine and adalimumab (HUMIRA) for Crohn's. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday. Next morning (on 28Jan2021) from Thursday until Saturday, she experienced dizziness and weakness as stated, "when I woke I was severely dizzy and just weak and that is continued yesterday, well let's say Thursday, Friday and yesterday. I am feeling better today but I wanted to report that". The patient wanted to know if she should receive the second dose of the vaccine because these two symptoms were reported as signs of a severe allergic reaction and that's a contraindication to receive the second dose of the vaccine. The patient had some blood work done on an unspecified date. The patient took some diphenhydramine hydrochloride (BENADRYL) according to her physician. The patient further stated, "I am just, I guess concerned, it does say on the paperwork that I received that you should not take the second dose if you had a severe allergic reaction which it list the dizziness and weakness one of those included so I am assuming that I should not take the second dose." The patient considered the events as non-serious. The outcome of the events was recovering.
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| 70 | 2021-03-03 | burning sensation, pain in extremity |
Patient woke up in the middle of the night the same day she received the vaccine and noticed pain an...
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Patient woke up in the middle of the night the same day she received the vaccine and noticed pain and burning on her upper left leg. She saw her doctor the next day who diagnosed her with shingles. The outbreak spread to the back of her knee in the meantime. She was prescribed ointment and medication to treat shingles.
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| 70 | 2021-03-03 | pain in extremity |
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ...
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right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
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| 70 | 2021-03-04 | feeling cold, hot flush |
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea...
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Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
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| 70 | 2021-03-04 | cold extremities, pain in extremity |
From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches....
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From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches. General ill feeling. Couldn?t go to sleep. Began to feel horrible. Cold feet. Took an Advil and within 15 minutes all symptoms went away.
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| 70 | 2021-03-05 | sensory loss, feeling hot |
Client c/o warmth feeling to the face. Client seen and assessed by EMT and vital signs are as follo...
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Client c/o warmth feeling to the face. Client seen and assessed by EMT and vital signs are as followed 173/62, HR 90, O2 99. Client verbalized that she felt decrease in sensation then was cleared to go home by EMS.
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| 70 | 2021-03-06 | weakness |
Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours afte...
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Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours after vaccination and lasted about 30 hours. Treatment was bed rest and naproxen sodium.
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| 70 | 2021-03-07 | pain in extremity | Aches, stiff joints, headache, very tired & very, very sore arm |
| 70 | 2021-03-07 | pain in extremity |
Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't s...
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Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't sleep, fatigue, rash at injection site and down the arm and then several days post injection rash on thigh
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| 70 | 2021-03-07 | weakness, discomfort |
Since March 1, every day I have felt dizziness and some nausea throughout the day, when I get up out...
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Since March 1, every day I have felt dizziness and some nausea throughout the day, when I get up out of bed in the morning, bend down and come up when doing laundry, cleaning, kitchen work, dressing, exercise and other normal daily activities. I must keep my upper body and head upright, and avoid bending, in order to prevent this dizziness. As a result, I feel weak and uncomfortable, and fear doing normal movement and activity.
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| 70 | 2021-03-07 | pain in extremity |
The following day she had gout in the middle toe of the left foot, which was in the same area that s...
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The following day she had gout in the middle toe of the left foot, which was in the same area that she had had a reaction about 4 years prior. She continues to have the pain. He did blood work and her uric acid is high, put her on Colchicine and it lowered her uric acid 1/2 point and followed the diet. He then put her on Allopurinol and will do more blood work in about 40 days. Also had arm soreness and tiredness, but they were no big deal.
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| 70 | 2021-03-07 | tremor |
began to pass out; because every time I tried to lift my head, I would start blacking out again; diz...
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began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
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| 70 | 2021-03-07 | pain in extremity |
pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting for hersel...
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pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 70-year-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809), on the left arm, via an unspecified route of administration on 05Feb2021 17:45 (5:45 pm) at single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP) and allergies to medications, food, or other products, both from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received an unspecified medication within 2 weeks of vaccination. On 05Feb2021, it was reported that the patient experienced pain in arm. No treatment was received. The event was considered as non-serious and it did not result in death, life threatening condition, hospitalization, disability, or congenital anomaly. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient was vaccinated in a school. The outcome of the event was reported as not recovered. The patient is not pregnant.
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| 70 | 2021-03-08 | pain in extremity |
3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and aroun...
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3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and around injection area 3/7/21 Arm worsen with the bruising and redness 3/8/21 & 3/9/21 No improvement in arm Took Benadryl- no change
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| 70 | 2021-03-08 | tremor |
AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWAL...
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AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWALLOW OR SPIT. TIGHTNESS MOVED DOWN TO SHOULDERS AND CHEST. PT WENT TO ER ; STARTED SHAKING UNCONTROLLABLY, THIS STARTED AND STOPPED 3 TIMES; ALSO HAD HEADACHE, FEVER AND CHILLS, ER GAVE HER IV BENADRYL AND PT IS STILL TAKING BENADRYL.
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| 70 | 2021-03-08 | weakness, flushing |
Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client s...
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Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client seen and assessed by EMT. A series of vitals: BP 90/20, HR 43, (2nd), BP 118/90, HR 64, O2 92. (3rd)108/84, HR 60, O2 90, Client advised to go to ER by paramedic. Client's daughter voiced that she will take her mom to ER herself. After 3rd vital assessment was taken client states that she will call her primary Dr. and inform her about the reaction and will follow up with what ever MD advises. Client cleared to go home by EMT.
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| 70 | 2021-03-08 | flushing, feeling hot |
Felt hot, face was flushed, began coughing, throat itched, blood pressure was elevated 184 / 118. H...
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Felt hot, face was flushed, began coughing, throat itched, blood pressure was elevated 184 / 118. Heart rate was " fast" but was not told rate, but even. No treatment given ...just monitored for approximately 45 min and sent home when coughing stopped and blood pressure was down to 164 / 106. They did check bp repeatedly, checked o2 levels, blood sugar, heart rate repeatedly. Told cannot return for 2nd vaccine. Primary doctor today verifies cannot have 2nd vaccine due to reaction to first vaccine.
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| 70 | 2021-03-09 | feeling cold, tingling |
Approximately two hours after the shot I experienced an odd sensation of a cold running throughout m...
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Approximately two hours after the shot I experienced an odd sensation of a cold running throughout my body. This was not temporary chills but a consistent 'ice water running through veins' cold that included a sort of tingling. This lasted for several days. It was not severe enough as to be debilitating, but was so unusual and prolonged that it was a little scary. I do have a fairly high titer for Rheumatoid Arthritis and considered that this might be my already hyper immune system going into overdrive. It was concerning enough that I am considering not taking the second booster shot of the Pfizer vaccine.
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| 70 | 2021-03-09 | muscle spasms |
Patient received vaccine in the morning 3/6/2021. In the evening, patient developed multiple episod...
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Patient received vaccine in the morning 3/6/2021. In the evening, patient developed multiple episodes of profuse diarrhea. She did become lightheaded, fell, and 'broke my tailbone.' She did see a family medicine physician 3/8/2021 - patient did pass out per the note but did not hit her head. +camps -nausea -emesis No known contacts to anyone with illness or diarrhea
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| 70 | 2021-03-09 | weakness, pain in extremity, tremor |
She received the vaccine, and went to bed at midnight and felt great all day long. She believes abo...
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She received the vaccine, and went to bed at midnight and felt great all day long. She believes about 5 minutes later started having chills. She has a weighted blanket and had that with 2 other blankets on her, and started shaking, and then her teeth started chattering and could not prevent them from banging together. She was afraid she was going to break a tooth. This lasted for almost an hour. She finally fell asleep and normally does not move when sleeping, and tossed and turned all night. She usually gets up a couple of times a night to use the bathroom, and did not get up until 6:00 Am, and when she tried to get up she was woozy, and was not able to walk due to feeling like she was going to fall over and almost fell in the bathroom but has grab bars that she was able to grab. She normally gets up at 4:00 Am, and got up at 8 after getting up at 6. She was not able to sit up and when she got up for the day was listing like a drunken sailor and not able to eat and managed to get some water down. She did take a Tylenol, and took her VS which were normal. She had tried to call her doctor but due to weakness was not able to. She was still uneasy from a deep sleep last night, but today she is feeling better but afraid of losing her balance. Her arm is still a little sore, but pretty good right now.
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| 70 | 2021-03-09 | tremor |
Systemic: Shakiness-Severe, Additional Details: Pt reported feeling extremely shaky a few hours afte...
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Systemic: Shakiness-Severe, Additional Details: Pt reported feeling extremely shaky a few hours after receiving her dose, so much that she could not drive anymore. She called the EMTs, they checked her vitals and said she was fine. However, she did get a hotel room becuase she did not feel safe driving home. only allergy is to pet dander. She will call back tomorrow just to give an update. She is going to call her PCP for further clarification as to what to do for the 2nd dose.
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| 70 | 2021-03-09 | feeling cold | exhausted, nauseated, achy, chilled |
| 70 | 2021-03-09 | weakness |
injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week ...
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injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week and dizzy
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| 70 | 2021-03-10 | flushing |
After client received her vaccine client stated she feels flushed and shaky. Vital signs obtained. ...
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After client received her vaccine client stated she feels flushed and shaky. Vital signs obtained. BP 126/83, HR 93, O2 Sat 99%.
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| 70 | 2021-03-10 | night sweats |
Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, n...
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Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, no appetite, brain fog, extreme fatigue, for 8 days or more. COPD so much worse that I had to use albuterol twice a day which I didn't use before lasting 2 weeks. No daily walk for 2 weeks because I couldn't balance properly. Sweats and chills not corresponding to temp fluctuation 2 weeks. Night sweats which I have never had before EVER. My scleritis kicked in really bad, worse than ever before. I still don't feel well 19 days later
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| 70 | 2021-03-10 | difficulty speaking |
Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next d...
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Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next day after vaccine and have continued for 36 hours. They are unresolved at this time.
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| 70 | 2021-03-10 | seizure |
Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mo...
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Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.
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| 70 | 2021-03-10 | numbness, one side paralysis |
Numbness and weakness in the right leg that began the night of receiving the 2nd Pfizer covid vaccin...
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Numbness and weakness in the right leg that began the night of receiving the 2nd Pfizer covid vaccination. It has continued to the present day.
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| 70 | 2021-03-10 | flushing |
Onset of full body flushing 1 min after receiving vaccine. Felt "tickle in my throat". Treated wit...
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Onset of full body flushing 1 min after receiving vaccine. Felt "tickle in my throat". Treated with 25mg IV Benadryl along eith saline and observed for 2 hours in the ED without any other symptoms and discharged to home.
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| 70 | 2021-03-11 | tremor, electric shock sensation |
Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body ...
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Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body Chills with severe trembling Fever Vomiting for a period of hours Severe itching on my back, shoulders and upper arms for two days
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| 70 | 2021-03-12 | weakness | Fever chills weakness extreme body aches for 2 days |
| 70 | 2021-03-12 | tremor | Uncontrollable Shaking x two days |
| 70 | 2021-03-13 | tremor |
12:15 a.m. Horrific headache, horrible body shakes and chills High fever, extreme fatigue, sore th...
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12:15 a.m. Horrific headache, horrible body shakes and chills High fever, extreme fatigue, sore throat, extreme pain in armpit Fluids, advil, lots of sleep. Still fatigued
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| 70 | 2021-03-13 | feeling hot, weakness, pain in extremity |
Felt hot (did not take temp) then had shooting pains through muscles, mostly extremities. This last...
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Felt hot (did not take temp) then had shooting pains through muscles, mostly extremities. This lasted approximately 6-8 hours, then abated. Afterwards felt weak for about 12 hours.
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| 70 | 2021-03-13 | tremor |
Flu like symptoms. Chills and hard body shakes that I could not control until I finally got warm, b...
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Flu like symptoms. Chills and hard body shakes that I could not control until I finally got warm, body aches, especially back of head and neck, extreme tiredness, I already have post covid tiredness, but this tiredness is worse than the post covid tiredness. I have been in bed since it started at 4 am Saturday, March 14, 2021
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| 70 | 2021-03-14 | tingling |
Belated sensation in mouth-dry. Not swollen but felt swollen. Cold sores in corners of mouth. Drynes...
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Belated sensation in mouth-dry. Not swollen but felt swollen. Cold sores in corners of mouth. Dryness of lips.
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| 70 | 2021-03-14 | tingling, pain in extremity |
I started to have tingling sensation to my left leg. I have history of DVT, hemochromatosis, hyperth...
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I started to have tingling sensation to my left leg. I have history of DVT, hemochromatosis, hyperthyroidism but is all managed. The issue is that the tingling sensation I was experiencing was moving in my left leg, was painful but then it went away. I went to the emergency room 02-25-2021 that started with a blood clot and they placed me on Xarelto medication. My PCP encouraged me to go to the ER. they did an U/S of my left lower extremity which showed blood clot. I am already on blood thinner medication and no one can explain or give me an answer as to why I have a blood clot after my vaccine when i am on blood thinner medication.
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| 70 | 2021-03-14 | pain in extremity |
left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old fem...
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left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 05Feb2021 13:30 (at 70 years old) at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included bulging discs and known allergies to Penicillin, Dilaudid, and Sulphur. Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (D), biotin, calcium, magnesium, and curcuma longa (TURMERIC); all from an unknown date for unspecified indications. The patient received these medications within 2 weeks of vaccination. At 70 years old, the patient received the first dose of BNT162B2 (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 15Jan2021 11:30 at a single dose for COVID-19 immunisation and experienced pain in left knee and down to ankle and knee arthritic. The patient was not pregnant at the time of vaccination; was not diagnosed with COVID prior to vaccination; did not receive any other vaccines within 4 weeks prior to BNT162B2; and has not been tested for COVID post vaccination. It was reported that after the administration of the second dose, the patient experienced left arm pain on an unspecified date. Patient realized that the pain was akin to what she felt in knee (after the first dose) but not as bad. No treatment was received in response to the event. Outcome of the event was recovered with sequelae. The event was reported as disabling. Information on batch number has been requested.
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| 70 | 2021-03-14 | pain in extremity, breast pain |
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor...
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syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-03-15 | muscle spasms, hot flush |
2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed a...
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2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed at home. Monday (3-15-21) did a few errands and had constant diarrhia By 7:00 pm did not feel well and went to bed. Had nothing to eat all day, and by 8:00pm was vomiting fluids only and more diarrhia. slept fitfully with muscle cramps, shivers, then seats-cold and hot throughout the night. Finally awake and out of bed my 11:00 am
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| 70 | 2021-03-15 | electric shock sensation |
About 1/12-2 weeks s/p injection, my nervous system became extremely hyper. I was getting electric s...
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About 1/12-2 weeks s/p injection, my nervous system became extremely hyper. I was getting electric shocks down to my right three middle toes. I got the vaccine on my left side. I thought it was my back (sacro-iliac dysfunction), but it doesn't follow a dermatone. Then my R thumb started getting the shocks, with pain on one side, numbness on the other. This went on for a couple of weeks then calmed down. I got my second shot on 2/15/21 and a week or so after that the electric shocks came back even stronger and they are still doing it, only it appears to be slowing down now. I went to my pulmonary doc for an asthma check and asked her if I should report this, and she said yes.
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| 70 | 2021-03-15 | pain in extremity |
I woke up the morning after receiving the second Pfizer Covid-19 vaccine, and the ball joint and toe...
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I woke up the morning after receiving the second Pfizer Covid-19 vaccine, and the ball joint and toe of my left foot was swollen, red and painful. I ended up taking methylprednisolone (Medrol Dose Pac) for it. A few days after I completed that course of medication, I had another reaction where the left ankle did the same thing, got blood tests and the joint was aspirated; the doctor injected lidocaine and a corticosteroid into the joint, also the Medrol Pac meds again. Seems to be okay now. My doctor considers it a flare of inflammatory arthritis, auto-immune.
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| 70 | 2021-03-15 | unresponsive to stimuli, seizure |
Phone call from husband on 3/12/21 at 2:43 pm that after leaving the Health Department around 12:20 ...
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Phone call from husband on 3/12/21 at 2:43 pm that after leaving the Health Department around 12:20 pm they drove to restaurant and his wife ate lunch. They drove home and she was resting in living room and he found her at 1:30 pm unresponsive. He called ambulance and she was transported to the emergency department at Center. He reported that the doctor was running tests and he would let me know what they find out. 3/16/21 3:45 pm phone call to, husband and he said patient was sent by flight for life to Center on 3/12/21. He reports that it was determined she had a seizure and then had another in the emergency department and was intubated due to low oxygen levels.
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| 70 | 2021-03-15 | feeling cold |
Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, ...
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Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, and from my neck to entire head, I felt swollen. Got home, collapsed in chair, had a faint sign of difficulty breathing, but not bad. Still felt swollen. Disappeared about 2 hours at home. Nausea getting worse. Feeling chilled, feverish, and dizzy. Unable to sleep that night, so nauseated I couldn?t even swallow water without wanting to puke. Shot on Tuesday, didn?t feel much better till Friday. Ok now.
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| 70 | 2021-03-15 | weakness, feeling cold |
she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; c...
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she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
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| 70 | 2021-03-16 | muscle spasms, tremor |
12 hours after shot, shaking and cold. Leg cramps. Little sleep. However, I went throughout my day ...
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12 hours after shot, shaking and cold. Leg cramps. Little sleep. However, I went throughout my day with no issues and symptoms ended around 6pm the next day.
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| 70 | 2021-03-16 | pain in extremity |
I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chi...
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I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chills; nausea; I would throw it up; arm was so bad, it had it's own pulse, a pulse of it's own, I couldn't lift it at all plus the pain was like a tooth ache pain; checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90; my chest was shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 24Feb2021 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included viruses, flus (I have had viruses, flus my whole life), five surgeries, gallbladder removed, and asthma, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) on an unspecified date, at the age of 70-years-old and experienced a very sore arm. On an unspecified date in Feb2021 the patient experienced, "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath". The clinical course was reported as follows: "I wanted to call today because I got the Pfizer COVID Vaccine 3 weeks ago, 03Feb2021 it was. After the first dose I had a very sore arm and that was it. It was more sore than normal vaccine, but it was that was all I had. After the second dose I was not aware that I would get sick to the extreme that I did. I found out afterwards that other people have said this, I did not know at the time. I thought I was going to die. I am a 70-year-old woman, I am not young, and I have had viruses, flus my whole life and I got so sick. First, I had over a 103 temperature, it came on suddenly, 12 hours to the minute after I got the vaccine. On top of that I had such bad chills I never saw anything like that in my life, 5 blankets on top of me, sweaters, sweatshirts and the fever was so high. I could not keep the Tylenol down because I had nausea and I would throw it up. So, I could not even get rid of it. Then on top of that my arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all, plus the pain was like a tooth ache pain, it was excruciating. I have had 5 surgeries, my arm hurt worse than all 5 surgeries put together. And I had my gall bladder removed and everything, nothing hurt to this extent. Now also I have asthma, nothing severe but I do have asthma, so I have one of those little oximeters and you put it on your finger and it checks your oxygen level and normally its 98-99, it went down to 91, all night it was 91, my chest was shortness of breath. I was ready to go to the hospital. And I did not know it was going to be that bad." When clarified about the treatment the patient stated that "yes, the Tylenol helped once I could hold it down. The doctor gave me something to stop the vomiting and the nausea. And then I could take the Tylenol and then the Tylenol worked great. But at first, I was so sick I could not hold the Tylenol down in my stomach I would throw it up, that was the problem." When asked about lab work the patient stated that she had not had lab work done since the first vaccine. She stated that she had stayed in the house because she had other health issues and was afraid to come out for 11 months. So she had not gone out to get anything done. The patient stated that she called because if a third dose was needed, she suggested that a smaller dose be given to small people. She stated that she took childrens medicine most of the time because she was tiny. She wanted to know if Pfizer in the future would be making doses for small people and doses for bigger people. Her suggestion was to have a separate booster to go by weight or by gender, men usually did not experience the same. The clinical outcomes of the events "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath" were all recovered/resolved on unspecified dates. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 70 | 2021-03-16 | migraine, pain in extremity |
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p...
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She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
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| 70 | 2021-03-16 | burning sensation |
Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relat...
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Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relative to rash. Rash location on arms, legs, chest, back, feet, hands, head. Rash was raised and red. Developed within 24h of COVID vaccine dose. Treated at home with scheduled diphenhydramine, Tylenol, hydrocortisone topical cream, and Pepcid. After two visits to PCP office, eventually treated with intramuscular steroid injection.
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| 70 | 2021-03-16 | pain in extremity |
Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontane...
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Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.
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| 70 | 2021-03-16 | flushing |
a few minutes after receiving her vaccine the patient complained of feeling flushed, lightheaded, mi...
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a few minutes after receiving her vaccine the patient complained of feeling flushed, lightheaded, mild headache. she had no rashes or shortness of breath. It was a few minutes before the patient reported to the observation nurse that she was having these symptoms. By the time I was called over, the patient stated she was already feeling better. Her vital signs were recorded and her case was discussed with the doctor on duty. The patient was kept for an additional 10 minutes of observation. Her symptoms completely resolved and she was discharged to home after the doctor saw her per the doctor's instructions. The patient left the clinic ambulatory with out any further complaints.
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| 70 | 2021-03-16 | tingling |
per patient: I was awakened at 0145 hours on 11 March with tingling in the RIGHT SIDE of my FACE an...
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per patient: I was awakened at 0145 hours on 11 March with tingling in the RIGHT SIDE of my FACE and JAW. The Right Side of my TONGUE and LOWER JAW along the GUM LINE were EDEMATOUS and worsening as was my Right Cheek. I knew immediately what was occurring as I have a HISTORY of ANAPHYLACTIC Response to BEE STINGS and MUSHROOMS. I have EPI PENS and BENADRYL with me 24/7. I am also a Registered Nurse. I immediately took 50mg of BENADRYL Orally at 0150 hours, and continued to monitor the progression of my symptoms and my vital signs. By 0330 the tingling in my face and jaw abated. The Edema began to lessen at approximately 0610. I DID NOT have to use one of my EPI PENS. I DID NOT make an Emergency Visit to the ER, nor to my physician. (pt also noted she attempted to send in four (4 ) VAERS Reporting Forms to know avail. I kept receiving "ERROR" COULD NOT SEND" messages and she called the VAERS telephone line 9 times, and left messages with no response).
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| 70 | 2021-03-17 | breast pain, pain in extremity |
VAXINATION GIVEN IN LEFT ARM AND LEFT BREAST IS SWOLLEN AND SORE, DO NOT FEEL INLARGED LYMPH NODES,...
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VAXINATION GIVEN IN LEFT ARM AND LEFT BREAST IS SWOLLEN AND SORE, DO NOT FEEL INLARGED LYMPH NODES, JUST SORE BREAST AND UNDERARM.
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| 70 | 2021-03-17 | feeling hot |
thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spo...
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thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E18982), via an unspecified route of administration on 21Jan2021 13:00 by injection once to left arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included apixaban (ELIQUIS) as blood thinner. Patient was calling about COVID 19 vaccine. She had the first shot 21Jan2021, and had had flu symptoms ever since on 21Jan2021 and when they gave the shot they didn't ask for her allergies or anything, and she read on a letter given after, she was taking blood thinners, she was not sure what they do to the vaccine, that wasn't asked of her either, before she decided whether to take second or not, she needed some answers, she hadn't had the flu for 40 years. Her shot was at 1PM, and about 6 or 7PM that night, she got hot and thought she would pass out and it went downhill from there. Patient did not have some medical problems that she checked off when she registered, none of that came through either. Patient was thinking about not taking the second shot if she didn't get some medical information. The outcome of event flu symptoms was resolving, outcome of other events were unknown.
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| 70 | 2021-03-18 | flushing | I experienced a red flushing and hives on my face as well as a tightening in my chest |
| 70 | 2021-03-18 | facial pain |
I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I cal...
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I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I called an ambulance at about 2:00 am on February 18, 2021, with severe pain on the left side of my face and left neck. The pain in my teeth felt like it was being drilled. I was nauseated and the ambulance people thought I was having a heart attack. My blood pressure is normally 110/65, but it was close to 200/104, I think they said. A few days later I went to another ER because the doctor thought I was having a stroke.
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| 70 | 2021-03-18 | feeling hot |
I immediately stated that the injection made me feel hot. Then my hands and face turned red. The c...
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I immediately stated that the injection made me feel hot. Then my hands and face turned red. The clinicians took my BP and it was over 170. They called the ER and took me directly there. The ER doctor administered Benadryl in IV. The redness started to go away and BP returned to normal. There was also a headache. Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days. Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
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| 70 | 2021-03-18 | tingling |
Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area. Reports no ...
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Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area. Reports no issues with the first does. At 10:39, observer alerted writer that patient stated she wasn't feeling well. Pt was brought back to close observation room. Initial BP was elevated, other VSS. She c/o chest pressure and that she can feel "every vein in my body". Denies any shortness of breath. Reports h/o CAD. Carries nitro with her. At 10:49 AM, reports that chest pressure is increased and now is feeling "tingling all over". States that the pressure doesn't feel as though she need Nitro. Advised that, due to symptoms, would recommend f/u in ED if symptoms continue. At 10:55 AM, Patient requests to be taken to the ED. Husband is accompanying her today. Patient was taken via wheelchair by HCP.
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| 70 | 2021-03-18 | flushing |
Pt reports post-vaccination facial flushing and scalp itching. Denies any shortness of breath, chest...
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Pt reports post-vaccination facial flushing and scalp itching. Denies any shortness of breath, chest pain or itchiness in throat. Requests benadryl if available. - Pt given 25mg PO benadryl, symptoms improved.
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| 70 | 2021-03-18 | tingling | Tingling/Itching all over body. Rash starting to form |
| 70 | 2021-03-18 | nerve pain, feeling jittery |
Went to bed at 9 pm, woke at 11:30 to "zings" (nerve zaps) in right side of head above the ear, on t...
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Went to bed at 9 pm, woke at 11:30 to "zings" (nerve zaps) in right side of head above the ear, on the outside of the thigh and front of the shin, on the torso at the lowest left rib. It was not just in those areas. Took two Extra strength Tylenol, slept again until 4 a.m. to similar "zings". Got up at 6 and the zings were still happening - not as frequently. Also felt a caffeine type buzz for much of today. Sat quietly in late morning and tried to calm the feeling. Seems better now - a very small zing after a couple of hours. Caffeine buzz is gone as of noon. This has never happened after a vaccine and I read that some nerve issues gave been seen.
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| 70 | 2021-03-18 | pain in extremity |
have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm ...
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have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm started hurting; Very tired; Very thirsty; One of legs got weak; achy; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration, in the right arm on 10Feb2021, 12:15 at a single dose for covid-19 immunization. The patient's medical history included ongoing Hashimoto's Hypothyroidism from 2000 (had it at least five years before a diagnosis), allergies year-round, depression, pneumonia, wheezing, calcium deficiency from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for Hashimoto's Hypothyroidism from an unspecified start date and ongoing; bupropion hcl (BUPROPION HCL) taken for depression from an unspecified start date and ongoing; loratadine (LORATADINE) taken for allergies year round from an unspecified start date and ongoing; aspartate calcium, aspartate zinc, calcium ascorbate, glucosamine sulfate, magnesium aspartate, manganese aspartate (BONE STRENGTH) taken for calcium from an unspecified start date and ongoing; carbinoxamine maleate (OMEGA 100), colecalciferol (VITAMIN D3), chondroitin sulfate, collagen, glucosamine (COLAGEN) taken for an unspecified indications from an unspecified start dates and ongoing. When she was older the patient was given the high dose Flu Vaccine and had this reaction where her arm was red from shoulder down to elbow. After that she told them not to give her the high dose Flu Vaccine. She gets the regular Flu Vaccine. She assumes it occurred year turned 65, but was not sure. She does not have a lot/exp/NDC to provide. The patient experienced arm started hurting and very tired (around 7:00-7:30), very thirsty (had to drink three tall glasses of water back to back, reported she was never that thirsty), one of legs got weak (for a brief moment one of her legs was very weak and noticed while walking from the living room to the bed room) and achy on 10Feb2021. It was reported that the patient took a bath with Epsom Salt and it id not help. She got in bed by 8PM. Normally she goes to bed around 9:30-10 PM, but she was very tired. She then followed up and stated she went to sleep after the news about 10:20. Then at 4:45 AM she woke up because her eyes were very dry. Stated she has a humidifier in the apartment and usually has no trouble with her eyes, but they were very dry. She also noticed her ribs were hurting and it was noticeable on 11Feb2021. She was also more achy, but it the ribs hurting did not last real long. Then she noticed she was wheezing (11Feb2021). She knows she was wheezing because she has had pneumonia in the past and had wheezing then. The wheezing she had after the vaccine was not real bad. It stopped after about 10-15 minutes or so. She had laid down in bed for a while then got up around 5:30 AM. She felt better around then, but it took until like around 8AM before she felt fully okay as her arm was still aching. The outcome of the event arm started hurting and achy was recovered on 12Feb2021; eyes dry, ribs hurting and wheezing recovered on 11Feb2021; thirst and muscular weakness recovered on 10Feb2021, and unknown outcome for the remaining events.
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| 70 | 2021-03-19 | weakness |
Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed ....
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Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed . Please help me . I have taken Tylenol
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| 70 | 2021-03-19 | discomfort |
This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of ...
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This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of neck, dizziness, difficulty swallowing. This persisted until 3/17. I had a similar reaction to the first dose. 3/15: Rash on face and neck. 3/16 Rash spread to chest and upper arms. 3/17 face swollen; headache, scratchy throat. 3/18: Symptoms subside by end of day, although skin still a little blotchy. I did tell the person who gave me the injection about my reaction to the first dose and she looked for the rapid response team to watch me, but she didn't find them. I suggest a sign in the waiting area indicating which symptoms are of concern (hard to distinguish immune response from allergy and/or anxiety attack.
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| 70 | 2021-03-19 | migraine, seizure | Two Seizures and 5 migraine headaches |
| 70 | 2021-03-20 | tingling |
Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Ton...
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Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Tongue raw and sore and loss of taste. Very tired and achy. Low grade fever and chills. Unable to put two sentences together. Fill like my head is full of fog.
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| 70 | 2021-03-20 | weakness, feeling cold |
Started chilling about 24 hrs. after vaccination.........then low grade fever for about 6 hrs. Felt...
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Started chilling about 24 hrs. after vaccination.........then low grade fever for about 6 hrs. Felt very sluggish, no energy, went to bed about 830 pm and slept thru to morning and symptoms were gone. I took Tylenol 2 times the the afternoon.
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| 70 | 2021-03-21 | feeling hot |
About five hours after receiving the vaccine my ears started to ring. At the same time I felt a rush...
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About five hours after receiving the vaccine my ears started to ring. At the same time I felt a rush of heat through my body and I became short of breath. But I experience shortness of breath quite often with my asthma so this is not unusual. But the tinnitus has not gone away after over two weeks ofter receiving the shot. I am worried it will get worse if I have a second shot.
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| 70 | 2021-03-21 | pain in extremity, muscle spasms |
Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fing...
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Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
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| 70 | 2021-03-21 | tenderness |
Left arm extremely tender, arm and leg muscles sore, low grade 99.2 temp and massive headache fro...
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Left arm extremely tender, arm and leg muscles sore, low grade 99.2 temp and massive headache from nose to back iofhead
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| 70 | 2021-03-21 | weakness |
Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise ...
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Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise My concern is that now post 23 days after 2nd vaccine, I?m still having fatigue, no endurance, mild/moderate body aches, worse at night, still some episodes of loose stools.
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| 70 | 2021-03-21 | pain in extremity |
The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I bega...
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The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I began having extreme fatigue and muscle aches throughout my entire body. I felt inflamed. The fatigue impaired my ability to walk and do normal activities. I mostly wanted to sleep. At first I did not associate the symptoms with the vaccine, but then realized it was probably associated. The fatigue and muscle aches lasted about 7 or 10 days.
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| 70 | 2021-03-23 | facial paralysis |
1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral ...
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1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral paresthesias 1046 Evaluated by medical control; vital signs include BP 160/90, pulse 55, respirs 14/minute, O2 sat 98% RA. With smile right side of mouth lower and asymmetric compared with left, confirmed by husband. Nonfocal neuro exam otherwise with normal neurosensory and eyebrow/forehead motor 1055 Reevaluated with similar findings 1100 Ambulance called 1115 Ambulance arrived for transport
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| 70 | 2021-03-23 | tingling |
12pm felt achy and lightheaded. Developed chills and headache. Pain and headache became severe with ...
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12pm felt achy and lightheaded. Developed chills and headache. Pain and headache became severe with no relief from Tylenol. Continued throughout day into evening. Sleep of and on. Unable to walk to bedroom. Dizzy and feeling faint. Husband pushed me, by walker, into bedroom and helped me get ready for bed. Could hardly stand or roll over in bed. This was 11pm. Woke up at 10:30am. No further aching. Headache remaining, but mild. Tight feeling around head. Still dizzy. All symptoms resolved by 10pm. Upper left arm warm to touch with no lump.
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| 70 | 2021-03-23 | weakness |
8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 ...
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8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 days . Then intermittent fever & chills . After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !) . Extreme fatigue for a week .
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| 70 | 2021-03-23 | weakness | Fever/Chills, Cough, Headache, Diahrrea, Dizziness, Nausea, Perspiration, Overall Weakness |
| 70 | 2021-03-23 | tenderness |
Got the vaccine on Sunday, when she awakened this morning 3/24/21 something was tender on her throat...
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Got the vaccine on Sunday, when she awakened this morning 3/24/21 something was tender on her throat area, and she felt it, and there was a round knot by her right side of her neck, the collarbone area. She said that you definitely know that it's there and that it was not there when she got the vaccine.
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| 70 | 2021-03-23 | flushing |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Date: 3/24/2021 Subjective is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated. She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes and increased in HR. Upon arrival to bay, HR 180-190. Pt's husband states pt with hx of svt. Usually in high 200's or low 300's if it comes on. Hx of having HR in the 150s at times. Usually resolves on its own with elevation of feet above pt's head per pt's husband. He is not worried about it but wanted to know what her pressures were doing. PT with alz. Pt's husband is main caregiver. ALLERGY REVIEW OF SYSTEMS: Redness went away after sitting down.: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative Previous Reactions: none Objective Vitals Vitals: 03/24/21 1045 03/24/21 1101 03/24/21 1115 BP: (!) 141/86 124/80 124/82 Pulse: (!) 180 (!) 158 (!) 150 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. Comments: Flushed appearance upon arrival to bay. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR came down to 150-160's after Trendelenburg position. Ice pack placed on chest. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. Mental status is at baseline. She is disoriented. Gait: Gait normal. Comments: Disoriented at baseline per pt's husband. Pt able to tell me who her husband is and their plans for cruise this summer. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water and Trendelenburg position Follow up response to treatment: fair. Patient discharge: AMA. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Discussed pt's HR despite of pt being stable here that they ought to seek further medical care in the ED. Pt husband declines as "she's done this before and I'm not worried. We will go to the hospital if she is not getting better. I think when we get home, in her normal environment, she will be fine." He voices appreciation for our evaluation and concerns. She was able to demonstrate assistance to standing position without reports of feeling dizzy or lightheaded. Pt color does look better. Redness is gone and she continues to report to feel well. Pt wheeled out in wheelchair. Husband is aware of our recommendations. APRN Electronically Signed 3/24/2021 10:59 AM Division of Health
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| 70 | 2021-03-23 | numbness, tingling, pain in extremity |
Severe pain in the upper arm in which she received the vaccine which started 8 days after administra...
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Severe pain in the upper arm in which she received the vaccine which started 8 days after administration. Associated symptoms include numbness and tingling in the right 1st and 2nd digits. fingers also turned white. Color change and pain improved with a medrol dosepak but pain has recurred off steroids.
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| 70 | 2021-03-23 | weakness |
Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5...
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Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5 minutes and were followed by an overwhelming weakness, confusion, later also by abdominal cramps, some urinary urgency- all gradually improved over 30-40 minutes. I felt later agitated, had dry mouth, headache- improved after drinking 8-10 cups of water. I did not seek help. I stayed in the shot area in a large tent.
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| 70 | 2021-03-23 | tenderness |
Swollen upper arm and tender for 2 days after the injection. The ringworm rash seemed to spread lik...
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Swollen upper arm and tender for 2 days after the injection. The ringworm rash seemed to spread like wildfire on the third day and within a couple of days, both my legs were covered with the blotches. I had continued using the tolnaftate but on Saturday the 13th of March I went to get medical advise at the local ER and was told to take Allegra and Clotrimazole-Betamethazone cream. The rash got worse and I called Dr. and he told me to contniue to take the Allegra but stop the cream and start with Lotrimin because the Betamethazone in the cream counteracts the positive effects of the Clotrimazole.
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| 70 | 2021-03-23 | tremor |
Tremor of R hand already had Essential Tremor of L Hand. Tremulous cheeks occ when smiling if movin...
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Tremor of R hand already had Essential Tremor of L Hand. Tremulous cheeks occ when smiling if moving head downward. Lower ext feeling tense quads, gluteus Maximus and chin feeling tremulous
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| 70 | 2021-03-23 | weakness, pain in extremity |
Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheade...
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Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheaded, fatigued, and weak all day, no fever, took ibuprofen that evening (day after vaccine), and symptoms resolved by the next morning.
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| 70 | 2021-03-24 | weakness, feeling cold |
After patient received vaccine and waited 15 minutes she asked if she could wait longer because she ...
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After patient received vaccine and waited 15 minutes she asked if she could wait longer because she didn't feel well. Paramedic was called and took patient to the EMS tent - per EMS pt was diaphoretic with hypotension and near syncope -after laying down BP normalized and pt resumed normal status. Pt requested to go to the ED. Pt is currently being treated with chemotherapy and had her last dose 5 days prior. She was brought in by EMS after appearing cool, diaphoretic, nauseous, and unwell after vaccine administration. Patient states that she was feeling nauseous, dizzy, and weak 1 hour after administration. She likely had a vasovagal-like response to vaccine administration. Did not lose consciousness.
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| 70 | 2021-03-24 | muscle spasms, tremor |
Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She ...
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Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot; Fatigue; had a low blood sugar episode she supposed; passed out/Unconsciousness; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; crashed unconscious to the floor/fell/fell backwards/caught her foot under the vanity; This is a spontaneous report from a contactable consumer (patient) reporting for herself A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 20Feb2021 11:00 (Lot Number: EN6201) as a SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation. Medical history included breast cancer from 1988 to an unknown date , ovarian cancer from 2015 to an unknown date , she has had lymph nodes removed from her right arm "30 years ago" from 1988 to an unknown date, pass out from unknown date to unknown date. Concomitant medication included olaparib (LYNPARZA) taken for ovarian cancer from Feb2020 at 150mg, 2 tablets in the morning and 1-2 tablets at night by mouth.She says she is a little person and couldn't tolerate the side effects of that, so she varies how many she takes based on her side effects. She says she is supposed to take 300mg in the morning and 300mg at night. She says how she takes it is, she takes 150mg or one pill in the morning, then one or two at night depending on how she is doing. Historical vaccine information included BNT162B2 dose 1, lot no: EL9264, route left arm for Covid-19 immunisation. Past drug history included on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out. The patient reported approximately 15 hours after the shot, on 21Feb2021 she had muscle spasms almost to seizure amount of shaking, full body muscle spasms. She clarifies that her side effects didn't kick in until 02:30AM on 21Feb2021. She says at 07:00AM on 21Feb2021 she got up and went into the bathroom and passed out, and had a low blood sugar episode she supposed. She crashed unconscious to the floor. She said that could be from the shot, but she is also a high risk patient, a cancer patient, and is on a maintenance chemo drug. She says on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out, so she doesn't know if that was related to the COVID shot or not. No testing had been done on high risk patients, so she thought maybe this could be a good heads up for something someone else may experience. Her side effects were on and off for several hours, the shaking and spasms would subside and then start again. She says that they went away, and then she got up and passed out, and her foot was all messed up, she doesn't know what she did when she fell, but she had it checked and it was not broken, it was all bruised and swollen, but it was not broken. She says this was her right foot. She says she thinks she fell backwards, and she thinks she caught her foot under the vanity. On unknown date, she experienced bruising of foot, fatigue, foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-24 | migraine |
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It wa...
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I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-24 | feeling hot |
Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeli...
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Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeling a little full; didn't feel tender exactly, just different. Bra felt slightly tighter fitting. Seemed to get better, then right breast tenderness again after second COVID shot, also in right arm on 27 Feb 2021, lot # EN 6202. Very mild discomfort diffuse through breast; 25 days after second shot (and after mammogram) nipple tender again, breast mild discomfort, including vague sensation of warmth in breast.
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| 70 | 2021-03-25 | feeling hot, muscle spasms |
70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg ab...
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70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg about 2 days (21 Jan 2021) after receipt of her 2nd BioNTech vaccine (injected in her left arm; no other vaccines given on that day). Patient did not self-treat. Rash continued on 26 Jan when patient was evaluated in Medical Center ER described as "3 small wheals located on left upper and lower extremity with excoriations"; she was treated with Benadryl 25 mg orally and the itching decreased and the rash significantly diminished. No other signs or symptoms concerning for allergic reaction. Patient also reports onset of muscle aches, starting within 48 hours of vaccine receipt; also reports onset of fatigue, headache, and feeling hot. The headache and feeling hot resolved within 72 hours, but fatigue and muscle aches continued. Reports muscles hurt in her arms legs, and chest. Around 22 Jan, patient began having diffuse joint pain in her extremities. The pain became significantly worse on Sun, 24 Jan. Patient self-treated with Ibuprofen with some relief. By 26 Jan, when patient sought evaluation at ER, she described the joint pain as "unbearable" and rated pain intensity as 9/10. In the ER, patient was afebrile and her exam noted: bilateral hand and wrist swelling (left>right), but no redness or warmth at joints; full ROM, but pain increased with movements. Diagnosed as reactive arthritis and prescribed Tiger Balm and Lidocaine patches, with continued Ibuprofen recommended. At follow-up appointment with patient's PCM on 29 Jan, she reported continued muscle and joint pains. She reported some relief with topical analgesics and Ibuprofen, but Ibuprofen upset her stomach, so was changed to Celecoxib 200 mg twice daily as needed. Topicals and Benadryl were renewed. (Benadryl helped rash, but patient ran out and had recurrence of pruritic rash.) Muscle pain continued in her extremities. Reported fair control of muscle pain with topical analgesics and Celecoxib. Reported having "muscle spasms" in her hands. Patient reported increased sensitivity painful sensation when she touched something cold. Reported using a pot holder to hold a cold can of soda to reduce pain. Joint pain primarily in hands, wrists, shoulders, feet, ankles, and knees. Reported swelling of hands and wrists resolved after about 2 weeks. She also had swelling of her left foot, which resolved. Reported some relief of joint pain with topical analgesics and Celecoxib, but joint pain interfering with sleep. Patient's fatigue continued. Spouse describes as decreased stamina. An example: they used to go out to do errands over a 2-hour period and it would not impact patient's energy level; now, after 2 hours of minimal-to-moderate activity, patient is exhausted. Follow-up with PCM on 8 and 18 Mar 2021 rash resolved, but generalized muscle aches and joint pains continue. No localized joint swelling. Full ROM. Labs ordered (see below) patient's Rheumatoid Factor was elevated; she is pending a Rheumatology evaluation (appointment on 17 April). No history of recent trauma or injury. No previous history of similar joint pain. No history of arthritis or Rheumatic disease. Not previously diagnosed with COVID and never tested positive for COVID; was quarantined in 2020 after returning from being on a cruise ship. After 1st COVID vaccine in Dec, she experienced a headache and local redness and tenderness at vaccination site, lasting less than 3 days.
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| 70 | 2021-03-25 | tenderness |
Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After rece...
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Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After receiving the shot she then proceeded to our monitoring area for 30 minutes. At 0836 pt c/o of mild pain in her left deltoid. RN observed the injection area to be slightly red. Pt no c/o of itchiness or SOB. RN provided the pt with an ice pack. VS 162/110 and pulse ox of 97-99%. At 0855 left arm redness notably decreased. At 0905 pt c/o of feeling SOB. O2 sat of 99% with HR of 114. Pt taken into exam area in back of clinic and put on a stretcher. Now c/o of left shoulder and neck pain. Area tender to touch. Pt placed in 2 liters nasal O2. Rapid response was called at 0915. Team arrived, evaluated pt, and then transported pt to ER for further eval and tx.
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| 70 | 2021-03-25 | tingling | Tingling and swelling from Elbow to hand in left arm |
| 70 | 2021-03-26 | flushing | Flushed face, rapid heartbeat, minor fever and chilla |
| 70 | 2021-03-26 | pain in extremity |
Very sore at injection site. Diagnosed with shingles on arm, extremely painful arm. As of this date...
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Very sore at injection site. Diagnosed with shingles on arm, extremely painful arm. As of this date, arm still very sore and seems lumpy!
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| 70 | 2021-03-26 | muscle spasms | Within 15 minutes of injection experienced cramping, diarrhea and nausea. Observed for 30 minutes. |
| 70 | 2021-03-27 | feeling cold, migraine |
Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over ...
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Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over 8 hours Muscle & joint ache Headache...at times like migraine with light sensitivity VERY TIRED Loss of appetite Disorientation Off balance
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| 70 | 2021-03-28 | numbness, pain in extremity |
RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began havin...
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RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began having chest pain radiating down her arm, chest heaviness, right arm numbness, and some shortness of breath. Vitals BP:146/78, O2 94% on room air. Patient also pale and diaphoretic. Taken by ambulance to emergency room. Patient has extensive cardia history per EMT report: has pacemaker, had stress test and scheduled for a cardiac procedure. 3/29/21 Phoned patients daughter to follow up with patient's status. Patient does not have cell phone and speaks Bosnian. During hospital stay, she reports her O2 sats were low, had a heart cath. procedure,
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| 70 | 2021-03-28 | facial paralysis |
Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 m...
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Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 minutes after shot followed by tingling around both upper & lower lips. Doctor on site saw that I was having an event which he thought was either a TIA or Stroke because my smile was crocked, lip was drooping and BP was very high. The doctor ordered an Ambulance who transported me to hospital as the doctor said they were equipped to handle such an event as they are a Trauma 1 hospital.
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| 70 | 2021-03-30 | numbness |
Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower...
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Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower half the visual field (as though I had rubbed my eye hard.; I had photophobia as well; I also had left sided facial numbness that lasted 30minutes.; My tinnitus became much louder and that is continuing.; felt confused; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:00 as SINGLE DOSE for covid-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. Medical history included fibromyalgia, chronic fatigue syndrome, non-specific autoimmune disorder, allergies to Sulfa, Penicillin-light rash each. Concomitant medications included fenofibrate and tizanidine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. Three hours post vaccination, patient experienced for 30 minutes visual hallucinations left eye, the lower half the visual field as though she had rubbed eye hard. Patient had photophobia as well. She also had left sided facial numbness that lasted 30 minutes. She noticed no drooping of eye lid or mouth. Her tinnitus became much louder and that is continuing. She felt confused for the rest of the day of vaccination. The events onset date were reported as 11Mar2021 03:00 PM. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. Patient didn't received treatment for the events. The outcome of events was recovering. Patient have no Covid prior vaccination nor tested Covid post vaccination.
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| 70 | 2021-03-30 | tremor, weakness |
Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous repor...
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Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous report from a contactable 70-year-old female consumer (patient, non-pregnant) received second dose BNT162B2 (Solution for injection, brand: Pfizer, lot number: EL3246) via an unspecified route of administration in Arm Left on 23Jan2021 at 08:15 AM for COVID-19 immunization. Patient medical history included High BP, Hyatal hernia. Concomitant medications included fish oil, atenolol, omeprazole, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER). Patient previously took rosa canina (ROSE HIPS, need to take over time) and had allergy. Historical vaccine included first dose BNT162B2 (COVID19, brand: Pfizer, lot number: EK9231) on 02Jan2021 at 08:45 AM on Left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Jan2021 20:45, patient had tired, headache, chills, fever, nausea, dizziness, weakness body shook for about a hour and half. No Seriousness criteria was reported. Outcome of events was recovering.
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| 70 | 2021-03-30 | muscle spasms |
leg cramping/severe leg cramps/pain; leg cramping/severe leg cramps/pain; This is a spontaneous repo...
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leg cramping/severe leg cramps/pain; leg cramping/severe leg cramps/pain; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9264), intramuscular, administered in Arm Left on 09Feb2021 12:15 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased, anxiety, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included Rosuvastatin (Tablet), orally ongoing at 20 mg once daily taken for blood cholesterol increased, Levothyroxine (Tablet), orally ongoing at 50 ug once daily taken for thyroid disorder and Sertraline (Tablet) orally ongoing at 50 mg once daily taken for anxiety. On 10Feb2021 09:00, the patient experienced leg cramping/severe leg cramps/pain. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was not recovered.
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| 70 | 2021-03-30 | tingling, pain in extremity |
sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sud...
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sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
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| 70 | 2021-04-03 | pain in extremity | right thigh pain Treatment : lovenox 80 sery |
| 70 | 2021-04-06 | facial paralysis, pain in extremity |
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, des...
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4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.
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| 70 | 2021-04-06 | weakness |
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h...
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Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
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| 70 | 2021-04-09 | pain in extremity |
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia...
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Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
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| 70 | 2021-04-15 | weakness |
Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks...
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Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks of continued symptoms suddenly had Afib with RVR event and went to Er
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| 70 | 2021-04-15 | weakness |
Patient is a 70 year old female with a PMH of TBI with residual memory loss, visual deficits and uns...
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Patient is a 70 year old female with a PMH of TBI with residual memory loss, visual deficits and unsteadiness who was admitted on 2/18/2021 with diarrhea and weakness. Patient tested positive for COVID-19 on 2/18/2021. She was not hypoxic and CRP was mildly elevated. Steroids and remdesivir were not indicated during the admission. Diarrhea improved overnight with IV fluids. Patient was discharged to home on 2/19/2021
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| 70 | 2021-04-17 | muscle spasms, feeling of body temperature change, pain in extremity |
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both...
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Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
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| 70 | 2021-04-24 | weakness |
My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; V...
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My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-04-28 | weakness |
platelets have been significantly dropping/platelets were down to 4,000 units; platelets have been s...
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platelets have been significantly dropping/platelets were down to 4,000 units; platelets have been significantly dropping/platelets were down to 4,000 units; Really Weak; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. Medical history included ongoing thrombocytopenia (diagnosed 4-5 years ago). No concomitant medications. Family medical history included high cholesterol. The patient previously received the first vaccine dose of BNT162B2 on 23Feb2021 for COVID-19 immunization. No adverse event (AE) following prior vaccinations. The patient's daughter stated that the patient seemed like she was having an adverse reaction since her second vaccination. The patient's daughter said that this started after her mother received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last 16Mar2021. The patient's platelets have been significantly dropping. The patient was rushed to the hospital because platelets were down to 4,000 units. The patient had thrombocytopenia but was managed well. The patient has Thrombocytopenia Disease and her hematologist recommended that she get the vaccine. Before the second vaccine, her platelets had been stable, not at normal range, but 78,000 to 71,000, which was normal for her. After the vaccine, the patient's platelet level has been significantly plummeting to single digits like 4,000 and then in a few hours shooting to 31,000 (in Mar2021). It was a consistent up and down for her. The patient was rushed to the hospital from her doctor's office and she was being admitted because her platelet level was down to 4,000 and she was getting a platelet transfusion. Ever since the patient got the vaccine, this started happening. Before, only once in a 3 year span, the patient's platelets dropped to 6,000 and now this is happening very often. The patient felt really weak for the last 2 days since 19Mar2021 (as reported) especially but it really started the same time as her platelets first dropped, so they took her to see the hematologist and fortunately they were able to get her in and did a complete blood count (CBC) and her platelets were down to 4,000 on 19Mar2021 (as reported). The treatment included Platelet Transfusions and was given steroid medication (they haven't received it yet but she was prescribed Promacta by Novartis). The patient has been in and out of the hospital 3 times within 2 weeks. Within a 2 week time frame, the patient has been there 3 times, 2 direct admit hospitalizations and 1 emergency room (ER) visit. She was rushed to the ER on either 05Apr2021 or 06Apr2021, but she was not admitted because when they took her labs at the doctor, her platelets were 4,000, but when they were rechecked in the ER they were 38,000 so the released her because it came up and was over 30,000. The patient was admitted to the hospital from her doctor's office on 09Apr2021 and released 10Apr2021. She was admitted to the hospital again on 14Apr2021. Event occurred after the second vaccine dose. The patient had a visit to physician's office for a couple of times. The outcome of the events was not recovered. Information on Lot/Batch number has been requested.
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| 70 | 2021-05-04 | seizure |
seizures; This is a spontaneous report from a contactable consumer (Patient's husband). A 70-year-...
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seizures; This is a spontaneous report from a contactable consumer (Patient's husband). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 70-year-old via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Lot Number: EN6203) as single dose, second dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Lot Number: EN8727) as single dose both for covid-19 immunisation. Medical history included High blood pressure, atrial fibrillation. No family medical history. No prior vaccination within 4 weeks. Ongoing Concomitant medications included rivaroxaban (XARELTO); losartan taken for hypertension; hydrochlorothiazide taken for blood pressure abnormal, fluid imbalance; diltiazem hydrochloride (CARTIA XT) taken for atrial fibrillation; loratadine. After the first shot, about a week and a half later, she started having seizures in Mar2021. Since the second shot, it had gotten worse. The event resulted in Emergency Room visit. She was taken in twice. The first time, she was in the hospital for 4 days. This occurred last month, in Mar2021. After the second dose, she had been hospitalized, the end of March, almost April. They took her twice. The first time, they did a bunch of tests and were questioning seizure or a stroke. At the end, they thought it was a seizure. She then came home and had it worse. They put her on medication. The patient underwent lab tests and procedures which included tests: all were negative, computerised tomogram: unknown results, electroencephalogram: unknown results, magnetic resonance imaging: unknown results all in Mar2021. The events outcome was not recovered.
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| 70 | 2021-05-06 | weakness |
Coughing; feeling dizzy and Lightheadedness; Weakness; Trouble Walking; This is a spontaneous report...
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Coughing; feeling dizzy and Lightheadedness; Weakness; Trouble Walking; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 11:40 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation (age at vaccination 70 years) . The patient medical history and concomitant medications were not reported. The patient experienced coughing on 27Mar2021 with outcome of recovered on the same day , feeling dizzy and lightheadedness on 27Mar2021 with outcome of recovered on the same day , weakness on 27Mar2021 with outcome of recovered on the same day, trouble walking on 27Mar2021 with outcome of recovered on the same day. Course of the event: The patient stated that five to seven minutes after the shot, she started coughing. She started talking to the nurse in the waiting room and she said lets have you sit down. The patient stated she then started feeling dizzy and lightheaded, and needed to lie down. They had no cots in the clinic, so she had to lie on the floor. The patient stated she had weakness and trouble walking. The patient stated this was all over in 3 hours and her family took her back to her care and she drove herself home. The patient stated she had a severe reaction to the first shot and the clinic refused to give her the second dose. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-05-06 | numbness |
ear is still blocked; ear aches; ear aches and is numb; no hearing in my left ear; This is a spontan...
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ear is still blocked; ear aches; ear aches and is numb; no hearing in my left ear; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 25Feb2021 at 17:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Feb2021 at 07:00, the patient woke up with no hearing in the left ear. Some hearing had come back but the ear was still blocked as of an unspecified date. The ear ached and was numb as of an unspecified date. The patient visited the ear nose and throat (ENT) doctor and was treated with steroids, twice, for the events. The patient was scheduled for an MRI. The patient reported that she was perfectly fine with no problems prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of "no hearing in my left ear", "ear is still blocked", "ear aches and is numb" was not resolved. Information on the lot/batch number has been requested.
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| 70 | 2021-05-13 | muscle spasms |
Throat and chest spasms; Throat and chest spasms; Lower lip and jaw swelling; Lower lip and jaw swel...
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Throat and chest spasms; Throat and chest spasms; Lower lip and jaw swelling; Lower lip and jaw swelling; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration on 08Feb2021 02:45 PM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 70 Years. Facility where COVID-19 vaccine was administered was at the Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included 6 Autoimmunes, asthma, diabetes 2, Celiac, depression, anxiety, Extra allele on chromosome for histamine production, Genetic extra histamine production, allergic to many meds, foods and environmental. Concomitant medications included certolizumab pegol (CIMZIA); pramipexole dihydrochloride (MIRAPEX); desvenlafaxine succinate (PRISTIQ); olmesartan medoxomil; All were taken for an unspecified indication, start and stop date were not reported. On 08Feb2021 14:45, the patient experienced throat and chest spasms with delayed lower lip and jaw swelling several hours later even with 50 mg Benadyrl. Swelling receded 36 hrs later. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Therapeutic measures were taken as a result of the events with 50 mg Benadryl repeatedly. Outcome of the events was recovered on an unknown date. Information on Lot/Batch number was available. Additional information has been requested.
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| 71 | 2021-01-12 | numbness |
Approximately 22 hours after I received the first vaccine my left arm from the elbow down to my hand...
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Approximately 22 hours after I received the first vaccine my left arm from the elbow down to my hand went numb. No tingling just no feeling. Could not hold anything and no strength in that arm and hand.
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| 71 | 2021-01-13 | unresponsive to stimuli |
71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10...
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71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was immediately started; no shock advised per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death.
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| 71 | 2021-01-14 | pain in extremity | Sore arm, fatigue |
| 71 | 2021-01-15 | cold sweat |
1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling,...
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1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling, cold sweat. Lasted approx. 20 minutes. Resolved after lying down..
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| 71 | 2021-01-17 | pain in extremity |
Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm ...
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Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm on 1/12/21. When I woke up on 1/13/21, I was very sick. I felt like I had a severe, very bad, horrible flu. I didn't get out of bed until 5pm that evening. No fever. No body or joint aches. Just extreme, overwhelming fatigue and feeling flu-y. This phase lasted about 24 hours. (my right am also hurt, but that was minor) I have a severe case of Sjogrens, a systemic autoimmune disorder. My most debilitating Sjogrens symptom is overwhelming fatigue. If I weren't retired, I would be qualified as disabled. Handicapped tag, etc. Since the vaccination, my Sjogrens has "flared." I feel terrible, exhausted, can't do anything. I have cancelled everything. All I can do is sleep, and feed the cat. I am directly connecting this Sjogrens flare to the vaccine. When I'm in a flare this bad, I usually take a course of prednisone. I have not done this because I don't want to modulate my immune system while it is building covid antibodies. I can't wait for the 2nd vaccine on 2/2/21!
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| 71 | 2021-01-18 | pain in extremity | Minor soreness in muscle of left calf |
| 71 | 2021-01-19 | hot flush, tremor |
I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at...
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I felt fine while monitored in the parking lot for 15 minutes following injection. On my way home at 25 minutes post injection I had an over-all body wave-type feeling (somewhat similar to a sustained hot-flash) and over-all disconcertingly odd feeling. This lasted about 4 minutes and was followed by shakiness that lasted about 5 minutes (total time a bit less than 10 minutes). Took my bp, pulse, O2 as soon as I got home (approximately 5 minutes post symptoms) and the readings were fine.
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| 71 | 2021-01-19 | feeling hot |
Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies ...
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Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies vomiting, denies shortness of breath, rash/hives, difficulty swallowing and other symptoms. Pt reports a single reaction to an antibiotic in the past, denies Hx of vaccine reactions. Pt states she feels cooler after removing two of her three long sleeve layers. Nausea treated with 8mg ODT ondansetron, with noted relief.
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| 71 | 2021-01-20 | pain in extremity, weakness |
Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day a...
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Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day after vaccine; fatigue and weakness on day 2 after.
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| 71 | 2021-01-20 | weakness | Tightness in chest , Hives, weakness, required visit to E.R. Given IV Benadryl Pepcid, prednisone |
| 71 | 2021-01-20 | discomfort |
couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a ...
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couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events. Information on the Lot/Batch number has been requested
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| 71 | 2021-01-20 | tenderness | slight left arm tenderness the day after vaccine |
| 71 | 2021-01-21 | tingling |
20 minutes after the injection my face around my right eye and down ward started to swell and tingle...
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20 minutes after the injection my face around my right eye and down ward started to swell and tingle. within the hour it went away.
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| 71 | 2021-01-21 | burning sensation, muscle spasms |
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ...
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Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
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| 71 | 2021-01-24 | burning sensation, numbness |
Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: fa...
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Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: face swollen, blotchy, numb eyes swollen, sore sockets, upper lip puffed out, burning face feel, asthma
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| 71 | 2021-01-24 | muscle twitching, speech disorder |
Extremely unusual pain at injection site, (compared to any other past injections) generally achey, ...
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Extremely unusual pain at injection site, (compared to any other past injections) generally achey, headache, occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day). There was one occasion where my left hand had a strange involuntary "twitch". I only mention that because on Saturday (1/23/21) i had a few episodes of speech difficulty (words "not coming out right")
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| 71 | 2021-01-25 | tremor |
1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 hea...
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1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 heart rate 90 2pm 176/72 heart rate 90 sat up 160/90 gave OJ to drink released 2:30 178/88 heart rate 80 Instructed to seek medical attention if further problems. Was walked to car
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| 71 | 2021-01-25 | one side paralysis | Began experiencing left sided weakness, Evaluated in ER, Medivac'd to other facility for stroke |
| 71 | 2021-01-25 | tingling, numbness |
light headed; tingling and slight numbness (like coming out of Novocain) in left side of face predom...
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light headed; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area.; tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 15Jan2021 08:15 at SINGLE DOSE for COVID-19 vaccination. Medical history included osteoporosis and gastroesophageal reflux disease (GERD). The patient was not pregnant. The patient was allergic to Codeine and derivatives. Concomitant medication in two weeks included denosumab (PROLIA), piroxicam (PAXIL), omeprazole, clarithromycin (CLARITIN). The patient previously took codeine and experienced drug hypersensitivity. On 15Jan2021 08:30, within 15 min after vaccination the patient became light headed, then tingling and slight numbness (like coming out of Novocain) in left side of face predominantly in the mouth area. Light headed went away within another 15 min and numbness within another 45, but the latter came back in the left cheek and forehead in approximately four hours. No treatment received for the events. No Covid prior vaccination, no Covid tested post vaccination. The outcome of the event light headed was recovered on 15Jan2021, of other events was not recovered.
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| 71 | 2021-01-26 | pain in extremity | Mild fever, nausea headache, extreme fatigue, muscle ache, stuffy nose, sore throat, sore arm |
| 71 | 2021-01-26 | one side paralysis, facial paralysis |
Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts...
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Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts, glaucoma who was transferred from Medical Center as a stroke code after she presented there for right-sided weakness, facial droop and visual changes. Patient was given TPA in the past she was within window and she was then transferred here for further management. Patient's symptoms continue to resolve. She was admitted in the ICU and managed by neuro critical care and neurology. Further imaging including CTA head and neck, MRI brain did not reveal any stroke. An assessment of small vessel disease was made which likely resolved after TPA was given. Patient was assessed by PMR and PT/OT and deemed safe to go home with family care and no restrictions. Echo, telemetry and EKG showed no signs of cardiac involvement. Patient was started Plavix x21 days and chronic baby aspirin. She was also started on Crestor 20 mg daily. Patient is to follow-up with neurology in 3 months as she got TPA. She will also follow-up with her PCP on discharge.
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| 71 | 2021-01-26 | tingling |
Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, ac...
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Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, across shoulder and up neck about ear level; Low back/ hip pain I haven?t had before, especially at night turning over in bed. Self-massage, change position
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| 71 | 2021-01-27 | pain in extremity |
Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a ...
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Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (BNT162B2 also reported as Pfizer COVID Vaccine, lot EL3247), intramuscular in the right arm on 13Jan2021 18:00 at SINGLE DOSE for Covid-19 immunisation (reported as prevention for age group). She received the vaccine in a hospital. Medical history included a Covid-19 patient on Mar2020, hypothyroidism and normally had headaches. No other vaccines taken prior to vaccination. There were no concomitant medications. On 13Jan2021 03:00, she had arm pain that was killing her through the night. She was a little achy, had a headache, but no fever. The outcome of events was recovering.
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| 71 | 2021-01-28 | burning sensation |
developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint ...
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developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint itching all over her body/mild itching today 'like when a nerve lights up'; she felt her left outer ear was burning until around 22:00 at night; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL0142 and expiry date:Mar2021) , via an unspecified route of administration on 13Jan2021 16:15 at a single dose in left arm for covid-19 immunization. There were no medical history and concomitant medications reported. She states that she had the first dose of the vaccine on Wed 13Jan2021 at 16:15 together with her husband, right after receiving the dose on left arm she felt her left outer ear was burning until around 22:00 at night and was milder the next day. She states that last night 14Jan2021 around 20:00, she developed a cluster type headache that lasted all night, she took ibuprofen (ADVIL) and around 22:00 the same night she developed pinpoint itching all over her body. She reported she still has some mild itching today 'like when a nerve lights up' and still has a 'little bit of a headache.' She wants to know if these were common side effects. The outcome of the event burning sensation recovered on 14Jan2021, while cluster headache and itching were recovering.
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| 71 | 2021-01-28 | muscle spasms |
fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, bra...
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fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, brain fog
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| 71 | 2021-01-29 | tremor |
11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the...
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11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the night. Fatigue
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| 71 | 2021-01-29 | tenderness |
Lymphadenopathy, possibly. Tenderness under armpit and in underside of arm. Started on day 3 follo...
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Lymphadenopathy, possibly. Tenderness under armpit and in underside of arm. Started on day 3 following the shot. Has continued until now (day 12). Tenderness has lessened in my lower arm, but continues in my upper arm and under armpit.
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| 71 | 2021-01-29 | feeling hot, difficulty speaking |
Pt received Covid-19 vaccine at 4:50 pm. patient's daughter, informed observer that her mother has...
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Pt received Covid-19 vaccine at 4:50 pm. patient's daughter, informed observer that her mother has complaints of her face feeling warm and itchy and a scratchy throat. Assessment completed by Dr., daughter to translate due to patient speaking limited English . 50 mg of Benadryl administered orally at 5:05pm. Reassessment completed at , 5:18 PM, face appears to be more reddened and facial swelling noted. Daughter also stated that her mother's voice is becoming hoarse. 125 mg of solumedrol given IM by, RN. at 5:20pm. Patient reassessed at 5:40PM, facial swelling and redness improving. Daughter states that mother 's voice is returning back to normal. and stated that the patient has informed her that she is feeling better. Patient discharged by Dr. at 5:43 PM at daughters request, stating that she will be monitoring her all night and will take her to the ER if symptoms return or worsen.
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| 71 | 2021-01-29 | tingling, burning sensation | Tingling lips, tongue, face. Tongue numbness and burning sensation |
| 71 | 2021-01-30 | pain in extremity |
This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours afte...
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This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours after receiving the shot, I began to feel aches and pains (like a cold was coming on). During the night I had some chills and the next day I was very achy and very tired. I napped about 4 hours during the day and was asleep by 8p.m. and slept for 12 hours. The next day (second day after the shot), the aches receded but I was still very lethargic for about another 8 hours. I began to feel 'normal' by evening and am felling OK today (third day after the shot). I did drink a lot of water during the whole time as I felt very thirsty (and I am normally a big water drinker!) I also had no appetite until this morning.
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| 71 | 2021-01-30 | flushing |
Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours ...
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Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours I am just very tired and having sporadic shooting pains in my head.
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| 71 | 2021-01-31 | tingling |
Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she ...
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Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she got a sensation ?like she was going to have shingles-tingling? shortly after her arm that she received the vaccine in was blotchy/rash from site down to wrist and entire extremity became swollen. It went away by itself by the next day. No other issues. She proceeded to call the CDC and her PCP.
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| 71 | 2021-02-01 | burning sensation |
Burning sensation in abdomen & upper track lasted for approx 3 hours. Bruise (black & blue) on t...
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Burning sensation in abdomen & upper track lasted for approx 3 hours. Bruise (black & blue) on the injection site (right arm).
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| 71 | 2021-02-01 | pain in extremity |
Next morning both lower legs (calves) were extremely achy. My walking was very difficult. Felt like ...
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Next morning both lower legs (calves) were extremely achy. My walking was very difficult. Felt like I exercised my legs excessively. Did not hurt when sitting or lying down. Lasted 2 days.
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| 71 | 2021-02-01 | pain in extremity | sore arm, nausea. |
| 71 | 2021-02-03 | migraine, tremor | Eye twitch with visual shaking Migraine headache |
| 71 | 2021-02-03 | feeling hot |
Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-y...
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Feeling some nausea; Feeling hot; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 29Dec2020 (12:45) at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 29Dec2020 (13:00), the patient was feeling some nausea; and was feeling hot. The patient had received an unspecified treatment for 'feeling hot'; and had received ondansetron for 'nausea'. The outcome of the events, 'feeling some nausea' and 'feeling hot', was recovered on an unspecified date. The patient was not tested for COVID-19 post-vaccination.
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| 71 | 2021-02-03 | muscle spasms, cold extremities, weakness |
Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps,...
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Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps, severe weakness.
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| 71 | 2021-02-03 | feeling cold, tremor |
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki...
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Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
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| 71 | 2021-02-04 | tenderness |
Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on ...
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Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on right side (like a canker sore)
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| 71 | 2021-02-04 | flushing |
Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78,...
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Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78, 20, 99%. Felt better after 15 minutes.
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| 71 | 2021-02-04 | tingling, burning sensation |
Tingle in left side of face, chin, and Burning in Back from Right arm to left arm, Treatment, with D...
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Tingle in left side of face, chin, and Burning in Back from Right arm to left arm, Treatment, with Doxycline and Predisone, second day some re-leaf.
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| 71 | 2021-02-04 | pain in extremity |
about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headach...
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about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headache, pain in my eyes, moderate arm pain and fatigue. I began feeling better about 10 hrs later but continued to feel fatigued the rest of the day and had body and head ache a couple more days. I had had covid in Sept 2020 and felt worse those 10 hrs than when I had covid.
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| 71 | 2021-02-04 | feeling cold |
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;...
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cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
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| 71 | 2021-02-04 | slurring, inability to speak |
hospitalization, intermittent drooling, difficulty finding words (like a broca's aphasia), slurring ...
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hospitalization, intermittent drooling, difficulty finding words (like a broca's aphasia), slurring of words, and absent seizure
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| 71 | 2021-02-05 | pain in extremity |
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light head...
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Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch. Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
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| 71 | 2021-02-05 | flushing |
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ...
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Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
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| 71 | 2021-02-07 | pain in extremity | 2 |
| 71 | 2021-02-07 | tingling |
APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. ...
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APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. Patient initially complained of tongue pain and a headache; she then began to develop throat tightness and her voice began to change and she began to clear her throat and developed a "tingling" sensation. EMS was called at 2:25pm. First dose of epinephrine 0.5mg was administered IM right anterolateral thigh at 2:25pm, the sensation of her throat closing persisted at 2:30pm and another dose was administered of epinephrine 0.5mg was administered IM left anterolateral thigh at 2:30pm. EMS arrived and patient left in ambulance at 2:35pm. Vitals: 2:20 pm BP 110/64 HR 85 O2 sat 97% 2:25 pm BP 102/64 HR 93 O2 sat 95% 2:30 pm BP 112/60 HR 87 O2 sat 95% 2:32 pm BP 120/82 HR 90 O2 sat 98%
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| 71 | 2021-02-07 | tremor, feeling hot, flushing, numbness |
Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of l...
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Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of lips with metallic taste. Blood pressure 160/100, Heart rate 125-130. O2 saturation on room air 96-98%. Patient transported to Emergency Room via private vehicle. Patient declined ambulance transport.
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| 71 | 2021-02-07 | facial paralysis, numbness |
Patient diagnosed with Bells Palsy, mild case. Symptoms include numbness and pain on the left side o...
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Patient diagnosed with Bells Palsy, mild case. Symptoms include numbness and pain on the left side of the patients face along the facial nerve. Patient also experienced left sided drooping of her cheek, lips and eye.
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| 71 | 2021-02-07 | pain in extremity |
Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from ...
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Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from top of legs down, headache but not quite as severe as when hospitalized last year. All symptoms resolved within approx. 20 hours except for the arm site.
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| 71 | 2021-02-07 | facial paralysis, bell's palsy |
Symptoms: Pain in back of neck, right side facial paralysis, swelling, right eye not closing, un ...
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Symptoms: Pain in back of neck, right side facial paralysis, swelling, right eye not closing, un even smile. Went to ER. Diagnosis was Bell's Palsy. Treatment included a course of prednisone and Valtrex and lubricating eye drops as needed.
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| 71 | 2021-02-07 | breast pain |
feels like a muscle pull; Breathing was a little compromised; Oxygen saturation was down; Pain on le...
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feels like a muscle pull; Breathing was a little compromised; Oxygen saturation was down; Pain on left side to left breast; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730, expiry date: Mar2021), via an unspecified route of administration on 15Jan2021 10:47 at SINGLE DOSE reported in left shoulder for covid-19 immunisation. Medical history included asthma from 1971 and ongoing Diagnosed 50 years ago, Allergies from 1971 Diagnosed 50 years ago, Sarcoids from 2008 Sarcoids, Biopsy in 2008 and that is when she was diagnosed, ongoing sinus problems, pneumonia, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. On 18Jan2021 07:00, on Monday, she had pain from her left side to left breast, it was a sharp pain. Monday and Tuesday, she had to sleep sitting up. Her breathing was a little compromised so she went on the breathing machine at 09:30. Her oxygen saturation went down a little. Oxygen saturation was down 09:30. Her oxygen saturation was probably at 91-92%. She thought it was Pneumonia, so they did a chest x -ray and her lungs were clear. She got it through hospital because she has higher risk. She feels like now it is better. Sometimes with deep breaths, it feels like a muscle pull on an unspecified date. She does have asthma and allergies and went on the breathing machine and she knew her oxygen levels were down. She has an oximeter that she uses to check it at home. She did not know the name of the medication she uses on the breathing machine. Today, she did not take a breathing treatment but her oximeter registered between 94-93. Usually she is at 95. She is at 94 right now. She did not have any pain at the injection site. She is unable to confirm if the injection was given intramuscularly. The breathing machine was the only medication she took. Relevant test: Chest X ray to rule out pneumonia on 20Jan2021 and it was negative. The outcome of the events Pain on left side to left breast and Breathing was a little compromised was recovering, not recovered for the event Oxygen saturation was down, while unknown for the event "feels like a muscle pull".
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| 71 | 2021-02-08 | feeling hot, pain in extremity |
Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and ...
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Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and arm pain
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| 71 | 2021-02-08 | tremor, flushing |
Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is h...
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Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met." And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
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| 71 | 2021-02-08 | inability to speak |
She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both ar...
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She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-02-08 | tingling, numbness |
Shortly after receiving vaccine, client experienced "excruciating episodes" of intense pain, tinglin...
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Shortly after receiving vaccine, client experienced "excruciating episodes" of intense pain, tingling, and numbness.
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| 71 | 2021-02-08 | tingling, numbness |
Stated fingers and palm were tingling/numb when she went to go home. Vitals taken, juice given, sta...
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Stated fingers and palm were tingling/numb when she went to go home. Vitals taken, juice given, stable, decided she was ok to go home.
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| 71 | 2021-02-08 | weakness |
Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4. Mild cough & nasal congestio...
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Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4. Mild cough & nasal congestion since 1/31.
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| 71 | 2021-02-09 | pain in extremity |
I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous rep...
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I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL3248, Expiry date: unknown) via an unspecified route of administration on right arm on 23Jan2021 at 08:45 AM at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Sjogren's syndrome, fibromyalgia and hypothyroidism. The patient has no Allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included methotrexate, atorvastatin and levothyroxine. The patient stated she had a mild headache for 2 days, sore arm and had some fatigue for 2 days on 23Jan2021 at 18:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events had a mild headache for 2 days, sore arm and had some fatigue for 2 days which was Tylenol and rest. The outcome of the events headache and fatigue was resolved on 25Jan2021 while outcome for sore arm was resolved on an unspecified date in Jan2021.
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| 71 | 2021-02-09 | numbness |
had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this ki...
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had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this kind of swelled and then like it was steamed; lips and her tongue were all this kind of swelled and then like it was steamed; her arm, both of her arms went numb; could not go to sleep; This is a spontaneous report from a contactable consume r(patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. Medical history included stated, the only thing was got the susceptible to blood clots, had that gene so that is one of the reasons took the vaccine other than that did not take any meds. The patient didn't even take any blood thinners because did not need them." (not clarified further). No concomitant therapy included. The patient did not know if it is the vaccine but she got really weird smell and then her lips and her tongue were all this kind of swelled and then like it was steamed. The patient stated, "In the tongue and my lips, it was like when you get chilli on them and a distinct type of smell. " And then her arm, both of her arms went numb and she had like sort of a hard time breathing. Now, that it went away but she just waited and waited and it lasted almost in the most of the night and then she could not go to sleep but it was something she had never had before and it was very strange. She did not know if you have that kind of reaction from people or you know if it has come up but she thought she better report it because she had not had my second dose yet. She had to get the second dose on 09Feb. No treatments were received. Outcome of the events was recovering.
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| 71 | 2021-02-10 | tingling |
After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 2...
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After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 20 minutes. From 7:00 thru 9:00pm had tightness in middle of chest and upper back discomfort. Next morning no reactions other than sore injection site.
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| 71 | 2021-02-10 | tremor |
Feb 10. 8:30 pm started bowel cramping, 10:00 pm to 1:30 am moderate diarrhea with bowel pain. Feb ...
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Feb 10. 8:30 pm started bowel cramping, 10:00 pm to 1:30 am moderate diarrhea with bowel pain. Feb 11 1:30 am moderate vomiting. Felt chills and shaking . No fever.
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| 71 | 2021-02-10 | pain in extremity |
On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was ...
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On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was fine the next day. Also muscle soreness in arm for approximately three days.
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| 71 | 2021-02-10 | weakness |
Patient had abdominal pain with vomiting last night. Abdominal pain and vomiting now gone but now wi...
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Patient had abdominal pain with vomiting last night. Abdominal pain and vomiting now gone but now with weakness and decreased appetite.
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| 71 | 2021-02-10 | weakness | Stomach pain , diarrhea and weakness/fatigue |
| 71 | 2021-02-10 | tingling | nose, lips, and cheeks tingling; no SOB or swelling |
| 71 | 2021-02-11 | pain in extremity |
I presented at ER with burning, throbbing right leg pains at upper calf and upper thigh area. The E...
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I presented at ER with burning, throbbing right leg pains at upper calf and upper thigh area. The ER doctor said it was not a blood clot, but was the beginning of Shingles on the back of my right thigh, buttock and downward just below the back of my knee. I was prescribed Acyclovir, Hydrocode with Tylenol and suggested topical creams. I was unable to find the Zostrix suggested so began with Caladryl and Terrasil cream as well as baking soda/water soaks a couple times a day. As of today, February 12, I still have leg pain, markings from the lesions and am unable to sleep more than a couple of hours a night without throbbing, burning pain especially at 2 lesion sites. Now taking Tylenol alternating with Tramadol for the pain.
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| 71 | 2021-02-14 | feeling cold |
The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and bet...
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The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; next day she felt fine, cold but it's cold; chills; headache; First dose was on 05Jan2021/ Received the second dose on 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm (by injection) on 22Jan2021 17:00 (also reported as 16:30) at a single dose for COVID-19 immunization. Medical history included allergic to yellowjacket (anaphylaxis) and bee venom. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient experienced chills and headache on 23Jan2021, next day she felt fine, cold but it's cold on 24Jan2021, itching and a rash on his right arm up to her shoulder and between her legs and small bumps on 25Jan2021, the rash now is getting little bumps on an unspecified date. Patient received Pfizer-BioNtech Covid-19 vaccine on Friday 22Jan2021 around 4:30PM (as reported). On Saturday she experienced chills and headache, next day she felt fine, cold but it's cold in the city, she didn't take anything (Tylenol). Last night she started to get itching and a rash on his right arm up to her shoulder and between her legs and small bumps. She would like to know if this side effects have been reported for the vaccine. The patient reported she is getting a little concerned. She had her 2nd dose of the Pfizer COVID vaccine on Friday, 22Jan2021. She had the side effects that Pfizer submitted in the brochure. She had them starting on Saturday. She had chills and a headache. The headache left her by Sunday morning. She now she has a rash that started last night in her thighs between her legs. Then this morning it is on her arms in the folds. She does not know if that is normal. She is wondering if this is a normal side effect and what to do about it. She has had anaphylaxis from yellow jackets before. She hopes she does not go that direction. Received the second dose on 22Jan2021 at 5 pm. The chills is hard to tell if she still has it as it is cold in the city. She took Tylenol for her headache. She used anti itch cream after she showered. The rash now is getting little bumps. First dose was on 05Jan2021 (LOT: EL0142). No expiration date or NDC for first or second dose is written on her vaccination card. She thought maybe it was her detergent, or bleach, but that is not it. Therapeutic measures were taken as a result of headache which included Tylenol and itching which included anti itch cream. The outcome of the event headache was recovered on 24Jan2021, of event itching and a rash on his right arm up to her shoulder and between her legs and small bumps was not recovered, while for the other events was unknown.
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| 71 | 2021-02-14 | weakness |
weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid in...
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weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid intake, and became bedbound 2 days. On 2/15, resident is improving slowly
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| 71 | 2021-02-15 | muscle spasms, pain in extremity |
I have a condition known as Spinal Stenosis. Diagnosed 3years ago. If creates alternating pain in ne...
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I have a condition known as Spinal Stenosis. Diagnosed 3years ago. If creates alternating pain in neck, shoulders and upper arms, mostly on my right side. I had the shot in my left arm. The next morning at 10:00 AM, I started having spasms in my upper right arm that continued for 6 hours. I have never had anything like this happen before. It was completely debilitating. I sat for hours with heating pad on neck and arm. It was so painful I had tears in my eyes for most of the day. I slept on and off while heat treating it. Then after about 6 hours it stopped. The next day the muscles in that area were sore.
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| 71 | 2021-02-15 | flushing |
Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system woul...
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Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system would not let me uncheck section-Medium, Additional Details: her oxygen saturations were 93-96% on room air all of January, she received her first vaccine January 20, 2021. She received her second vaccine February 3, 2021. Her sats for February were 92-94% up until the sixth of February when she noticeably dropped to 91% on room air, she started being supplemented occasionally with oxygen on the 8th. She continues to be supplemented with oxygen. Not sure if related to vaccine or not
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| 71 | 2021-02-16 | weakness |
Started coughing heavily and very weak - Unable to stand up on her own and could barely walk 5 ft wi...
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Started coughing heavily and very weak - Unable to stand up on her own and could barely walk 5 ft without stopping to catch breath. Administered her inhaler (only taken when having asthma issue due to allergy or exercise) and measured Sp)2 which was at 87 Took my mother to the ED and she was diagnosed with Bacterial Pneumonia - Was tested for Covid-19 which was negative Antibotic Azithromycin was prescribed at ED
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| 71 | 2021-02-17 | cold sweat |
This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (no...
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This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number expiry date not reported), via an unspecified route of administration in left arm on 05Feb2021 00:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood pressure abnormal and chronic kidney disease. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram, diltiazem, amlodipine, calcitriol and iron. The patient experienced cold sweat, slight fever and chills (all non-serious) on 06Feb2021 03:00, no treatment. The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 71 | 2021-02-17 | nerve pain |
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chil...
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passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
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| 71 | 2021-02-18 | bell's palsy, nerve pain |
Bell's Palsy Trigeminal nerve pain in jaw Swollen glands and lymph nodes in neck, throat, right brea...
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Bell's Palsy Trigeminal nerve pain in jaw Swollen glands and lymph nodes in neck, throat, right breast, under arm
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| 71 | 2021-02-18 | weakness |
Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m. nausea ...
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Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m. nausea and then vomiting repeatedly throughout the day, body aches and terrible headache, no fever but chilled where teeth were actually chattering, running nose all day, acid reflux, no appetite but even water made me vomit, I became very weak. Slept a lot on and off all afternoon. Next day thursdayI had no symptoms but was weak from all the trauma of the day before. Friday I felt fine
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| 71 | 2021-02-18 | seizure, tremor |
Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe n...
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Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe nausea.
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| 71 | 2021-02-18 | feeling cold, migraine | Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired |
| 71 | 2021-02-18 | tremor | Fever 102.5 with shaking chills and abdominal cramps |
| 71 | 2021-02-18 | pain in extremity |
I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I ...
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I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I had only a brief episode of chills, nausea and cough for several days. My arm was sore. My second shot 21 days later was a different story. I had it in right arm because my left arm was still aching. ( 01/21/2021 ) date of my second vaccination. Since then I have continually had pain "all over my body" My bones and muscles literally ache so badly I cannot sleep. I have called for appointment with my Dr because it isn't going away. I had a cough ( I never cough) until this past week. My concern is the ongoing aching and soreness in different spots on my skin bones and muscles. My shoulders, neck and pelvic region.
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| 71 | 2021-02-18 | flushing |
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re...
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Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 71 | 2021-02-18 | discomfort, pain in extremity |
Received complaint call 2/19/21 from patient regarding administration site being anterior arm for 1s...
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Received complaint call 2/19/21 from patient regarding administration site being anterior arm for 1st dose of Covid-19 vaccine on 2/16/21. Submitted photos with band-aid placement towards anterior mid-upper arm. Complaints of pain/discomfort to arm (whole arm) also in shoulder area. Discussed that arm discomfort can come with vaccination as an expected outcome. Describes that she did not have pain in arm during injection when administered. Clients concern is regarding administration and if administered in tissues versus muscle if vaccine will still be absorbed by body and be effective. Consulted with "medical professionals" regarding technique and was encouraged to call vaccine administration site.
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| 71 | 2021-02-19 | migraine, electric shock sensation |
1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excru...
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1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excruciating stabbing electrical pain on the right side of brain since 2/15/21 3. Joints ache, back hurts started 4 days after injection 2/15/21 4. Feverish, malaise, started 4 days after Pfizer 2 on 2/15/21 5. Pfizer vaccine shot 2 has impacted my life negatively since date of injection 2/15/21. I am not well enough to get out of bed and participate in my daily routine. I need ice on my head for non stop headache and stabbing head pain. Side effects suck.
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| 71 | 2021-02-21 | weakness, pain in extremity |
Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right kne...
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Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right knee and overall not feeling well; Feb 18 felt lightheaded and weak with standing through out the day; Feb 19 weakness and lightheaded much worse, had several episodes of vomiting and become too weak to stand; went to ER
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| 71 | 2021-02-21 | tremor | Fever, chills, shaking,body aches, headache, dizziness, fatigue |
| 71 | 2021-02-22 | cold extremities, feeling cold |
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, he...
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4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
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| 71 | 2021-02-22 | facial pain, pain in extremity |
Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating h...
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Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore. February 23rd most symptoms gone except lethargy and cold sore.
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| 71 | 2021-02-23 | pain in extremity |
10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable cons...
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10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has a question about the COVID-19 vaccine. She stated that she thought she had a simple question, and she called the COVID hotline, and the CDC and they just keep bouncing her around. She said she had her first dose of the vaccine on 16Jan2021, and wasn't bothered by it, she had just a bit of soreness when she touched her arm (unspecified date in Jan2021), but 10 days later, on 26Jan2021, her arm got red, so she is wondering if this could be a delayed reaction. She stated that she is not having bad effects, she is just wondering why it would pop up after so many days. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 71 | 2021-02-23 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-...
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Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 15:15 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. Medical history included hypertension (HTN), gastrooesophageal reflux disease (GERD), total hysterectomy and osteoarthritis, all from an unknown date and unknown if ongoing. The patient was not pregnant. There were no known drug allergies. Concomitant medication included celecoxib (CELEBREX), omeprazole magnesium (PRILOSEC), estradiol (ESTRACE), metoprolol succinate (TOPROL XL) and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). It was reported that the patient experienced right sided neck pain which began a couple of days after vaccination on 06Feb2021 07:00. On 05Feb2021, her right eye was twitchy. On 06Feb2021, the right side of her face felt swollen. It felt like when you go to the dentist and get numbed. She tried drinking a liquid and it ran out of the right side of her mouth. She went to urgent care and they sent her to the emergency department. She had a CAT-scan, MRI and blood work done which all came back normal. Her right eye was not closing all of the way and they diagnosed her with Bell's Palsy on 07Feb2021. She was prescribed a course of prednisone and Valtrex. She has continued to have right-sided facial paralysis and her right eye will not close. She had had severe pain in her right eye and had to tape it shut to sleep and often during the day because it dries out. She was using Systaine eye drops every couple of hours and an eye gel at night. She was concerned about getting the second dose because she does not want this to get worse. There were no other vaccines in four weeks. There was no COVID prior to vaccination and was not COVID tested post vaccination. The outcome of the event was not recovered.
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| 71 | 2021-02-23 | numbness |
Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spon...
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Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in right arm on 23Jan2021 13:45 at single dose for COVID-19 immunisation in facility type other. The patient's medical history included asthma, unspecified auto immune, sickle cell trait, reflux. The patient have allergies to medications, food, or other products. Concomitant medications included nifedipine (CELEBRATE) at 200 mg, mirtazapine at 7.5 mg, vitamin b12, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 23Jan2021 04:00 AM, the patient experienced chest pain and pressure, numbness on left jaw, arm and hand. The adverse events result in emergency room/department or urgent care. The events were considered as non-serious by the other healthcare professional. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 71 | 2021-02-23 | night sweats |
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren...
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Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
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| 71 | 2021-02-23 | difficulty speaking |
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have...
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Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
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| 71 | 2021-02-23 | tingling, numbness |
Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noti...
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Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.
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| 71 | 2021-02-23 | flushing | Very severe chills, flushing, hives, nausea |
| 71 | 2021-02-23 | tenderness |
When the patient returned for her second dose she reported that she had pain and a marked decrease...
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When the patient returned for her second dose she reported that she had pain and a marked decrease in mobility in that arm and shoulder for about 2 weeks. She stated it is much better but still sore to the touch. She left the original band-aid in place from that vaccination and indeed, a worn band-aid was in place. The injection site was very high in the left shoulder, near the boney prominence.
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| 71 | 2021-02-24 | hot flush | - erythema diffuse body, hot flashes, headache and ecchymotic areas |
| 71 | 2021-02-24 | pain in extremity |
1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild head...
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1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild headache first couple days, severe vertigo day 5.
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| 71 | 2021-02-24 | tingling, flushing |
Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their finger...
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Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their fingertips. Denied CP, SOB, or difficulty swallowing. EMS evaluated patient on-site. Patient was hypertensive (172/92) with all other vitals WNL. Physical exam was unremarkable. Patient refused transport to ED for further evaluation.
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| 71 | 2021-02-24 | feeling hot |
Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet f...
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Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet for awhile, projectile diarrhea began. Then vomiting. Same symptoms I had with Covid in June. extremely tired for about a week. Called my son who works for Pfizer the next day (the 4th of February). I want to reschedule my second vaccine for later in March because my Endocrinologist has put in a referral to have my antibodies tested. Unfortunately I just had a tooth extracted and am on antibiotics, not sure if that will affect the antibody test or the second vaccine.
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| 71 | 2021-02-25 | pain in extremity, feeling of body temperature change, feeling hot, feeling cold |
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we...
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My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
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| 71 | 2021-02-25 | cold extremities |
On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% ...
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On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% on 3L oxygen, hands cold, pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine, VITd2,hydralazine, synthroid, lisinopril, mag ox, folplex, pantoprazole, potassium chloride, ellipta, ensure, hydrocortisone cream, boost, deprox, xanax, morphine, lorazepam, tylenol, albuterol inhlation, ventolin inh.
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| 71 | 2021-02-26 | pain in extremity |
I had a sore arm a few hours after the injection as well as swelling and redness at the site. It con...
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I had a sore arm a few hours after the injection as well as swelling and redness at the site. It continued for a day or two. No problem until my arm started itching Thursday and I noticed the redness and itching as well as a little swelling.
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| 71 | 2021-02-26 | pain in extremity |
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the n...
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Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face. Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.
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| 71 | 2021-02-26 | flushing |
Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused bena...
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Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused benadryl due to previous reaction. Took asa 81 mg and zyrtec 10 mg. Symptoms resolved.
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| 71 | 2021-02-27 | tremor |
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted...
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12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose): HA, lethargy, fogginess and tiredness
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| 71 | 2021-02-27 | pain in extremity | Moderate to severe pain in right wrist, fingers & arm |
| 71 | 2021-02-28 | weakness |
Patient presented to Hospital via EMS secondary to a fall outside where she fell of her hands and kn...
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Patient presented to Hospital via EMS secondary to a fall outside where she fell of her hands and knees complaining of weakness and unable to get self up.
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| 71 | 2021-02-28 | tremor |
Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 min...
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Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 minute observation time, was feeling fine and left. She returned to the vaccine clinic around 1415 reporting that she was having trouble breathing. Security called the charge nurses and alerted them that a patient needed assistance. Writer came out to patient who was seated in her car. We assessed patient who was visibly having difficulty breathing and was unable to respond to questions without difficulty breathing. Emergency medication box was opened and epinephrine was prepped. We assessed patients allergies and recent medications taken. Patient denied hx of breathing problems or anxiety. Pt denied chest pain. Per protocol for potential allergic reaction, 0.3ml of epi was given at approximately 1426 via IM injection in the pt's left arm. ED triage nurse was called and asked to come assist. Two ED technicians with stretcher arrived and with writer accompanying them transported pt to ED.
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| 71 | 2021-02-28 | feeling hot |
Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experie...
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Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experienced. The pain extended below my left rib through the area above my hip to my navel and then to my entire abdominal area. As noted, it ranged from severe cramps (maybe only a 4 on a NPRS) to searing pain that I would mark as a 10 on a NPRS. This subsided and then surged about 5 times in the space of 30 minutes. At one point, I got very hot, but I didn't have a fever. The pain was so bad and I felt so horribly sick that I was about to ask my husband to take me to the ER. I had a Cesarean section in 1978 followed by two natural, unmedicated VBAC births in 1981 and 1985, and, although I know we "can't remember pain," the pain I experienced last night was far, far worse than the pain of childbirth. After it went away, everything immediately went back to normal, as if it hadn't happened.
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| 71 | 2021-02-28 | burning sensation |
She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a ...
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She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.
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| 71 | 2021-02-28 | weakness, numbness | Weakness, dizziness, numbness in face, hypertension-evaluated by EMS and refused transportation. |
| 71 | 2021-02-28 | numbness |
severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itchin...
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severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer. A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; "known allergies: comparing." Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received. The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.
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| 71 | 2021-02-28 | weakness | strength difficulty, tiredness, leg weakness, |
| 71 | 2021-03-01 | facial pain |
48 hours after shot in left arm I started to have a earache on left side, traveled down the left sid...
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48 hours after shot in left arm I started to have a earache on left side, traveled down the left side of face, into jaw area and down left side of my throat like tonsils and into neck area. Into 72 hours after shot my face, neck and throat area started swelling. At that time I went to ER for assistance due to the swelling and pain. The ER after taking review thought it a infected saliva gland and treated me for that. As told by ER if no large progress contact my local Dr. and see ENT. On Tues. (one week from Covid injection) I was in touch with my local Dr. they had me come to their office for some care and scheduled me with a ENT. They have been able to get the profuse swelling down out of the left side of my face, neck and throat. I'm scheduled for a CT scan on March 5, 2021 to see where the original problem started. I'm contacting you for two reason's 1. I have a March 10th. appointment scheduled I need to cancel and am having issues doing this. Even in light of all this I want to reschedule for late April for my second shot and am not able to do that as well. 2. Can you assist with any information if this has happened to other folks and if I should be clear to take my second dose. This has been quite a nightmare and hard to bring under control. I believe in the vaccine and this maybe just a quirk in how it happened but any information you can give me would be welcome. I have looked on the website and it does say that there have been people who have also had symptoms like this from the shots where the side they get the shot on reacts. Thanking you in advance for your time and assistance.
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| 71 | 2021-03-01 | weakness, pain in extremity |
About two hours after receiving vaccine #1, I had the feeling of being high--woozy, light-headed, a ...
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About two hours after receiving vaccine #1, I had the feeling of being high--woozy, light-headed, a feeling of moving in slow motion and feet not quite touching the ground. I felt weak the following day, as if recovering from an illness, but the feeling in my head was gone. Only a slight soreness in my arm remained.
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| 71 | 2021-03-01 | muscle spasms |
Red rash around middle of my body from below my bra line to below my panties and on my back, it does...
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Red rash around middle of my body from below my bra line to below my panties and on my back, it doesn't itch or hurt, just lots of red spots everywhere. Leg and foot cramps.
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| 71 | 2021-03-02 | pain in extremity | Chills, body aches, headaches, slight nausea, sore arm |
| 71 | 2021-03-02 | feeling of body temperature change |
Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fa...
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Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fatigue Was sick for 17 days. Dr. prescribed steroids and nausea medication.
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| 71 | 2021-03-02 | weakness |
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a co...
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Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
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| 71 | 2021-03-02 | pain in extremity |
could not get her legs to work; her arm was sore; Dizzy/ Dizziness was reported as worsened; This is...
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could not get her legs to work; her arm was sore; Dizzy/ Dizziness was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the right arm on 27Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included peritoneal dialysis from Apr2020 and diabetes (diagnosed about 30 years ago) both ongoing; blood thinner, 2 stents a and a balloon from Dec2020 and high blood sugar. There was no family medical history. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) for stents, insulin detemir (LEVEMIR) for diabetes, insulin aspart (NOVOLOG) for high blood sugar during the day and clopidogrel bisulfate (PLAVIX) as blood thinner all were ongoing. The patient stated that her arm was sore on 27Jan2021 and that was no big deal. She said that she got so dizzy and was walking like a drunk. Dizziness was reported as worsened. Patient said that last night (31Jan2021) she tried to get to the bathroom, but she could not get her legs to work. She said that her husband had to lead her to the bathroom with a walker and when she was done, she could not get back to bed. She was scared to death last night when her legs would not work. She said that she thought her symptoms would just go away. What should she do about her symptoms? The facility where the vaccine was administered was in a clinic. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the events was not recovered.
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| 71 | 2021-03-03 | tingling, numbness |
Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 min...
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Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 minutes then was ok After 1 hour I had I think like brain fog and hard time to navigate my phone. Seem just like confused or light headed kind of during day. Misplaced phones or things next day Next day at night just felt around 11pm getting ready for bed my head was ok and I could think ok again
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| 71 | 2021-03-04 | bell's palsy | Bell?s palsy. Left eye will not close and left mouth droopy with muscle weakness left side. |
| 71 | 2021-03-04 | pain in extremity | Fever, headaches, chills, sore arm. Loss of taste that started on day 3 and lasted 24 hours. |
| 71 | 2021-03-04 | weakness |
Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started aroun...
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Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started around 7am on March 3rd, when she woke up. The symptoms lasted almost all day, and he started to feel better around 6:30pm on the same day, March 3rd. He was able to eat and drink at this time without feeling nauseous. On March 4th, he experienced mild headache and was feeling a little dizzy, but much better. She is able to eat and drink, and move around the house now.
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| 71 | 2021-03-04 | tingling |
Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80. ...
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Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80. Once symptoms subsided paramedics release pt. to leave.
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| 71 | 2021-03-05 | pain in extremity | Moderate arm pain Shooting pain in armpit sharp headache, body aches , chills Low fever 99-100 |
| 71 | 2021-03-05 | pain in extremity |
This is my second vaccine. Same results as the first one, They are now calling this covid arm or ...
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This is my second vaccine. Same results as the first one, They are now calling this covid arm or Maderna arm per on-line news, but I got the pfizer vaccine (not Maderna). First dose this reaction started 9 days post injection.. You have my report. This time it is in the other arm and the reaction started 5 days post shot (today) . The area is hot and raised. Area is larger than my first reaction: now 4 x 4 inches in a pyramid shape. It does not itch but it is painful. I have no other discomfort.
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| 71 | 2021-03-05 | pain in extremity |
This was the second shot in series of 2. First shot only gave me a sore arm at site & was administer...
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This was the second shot in series of 2. First shot only gave me a sore arm at site & was administered on February 6, 2021. Second shot was administered on March 3, 2021. Started feeling these adverse effects about 9 or 10 am the following morning, 3/4/2021. Symptoms were soreness at site, in muscle that goes to the neck, headache, soreness across upper back/shoulder to shoulder. By 4 pm on 3/4, my entire body was reacting with extreme joint pain in all joints, extreme joint stiffness, skin was tender to the touch, temperature of 100.1, sore/stiff neck, and continuing headache. Temperature ceased around 11:30 pm but all other symptoms remained upon going to bed at 1 a.m., 3/5/2021. Upon waking at about 7:30 am 3/5/2021, all symptoms had diminished enough for me to go to an appointment at 10:45 am. However, by the time I headed back home at about 1:30 pm, I was so sleepy I could hardly keep my eyes open. More stiffness and achiness had returned too, especially a sore left underarm. Not the extent of night before, but enough to be uncomfortable. Today, 3/6/2021, I have noticed a sore muscle traveling from my left underarm down to my waist.
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| 71 | 2021-03-05 | flushing, feeling hot |
Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs. Tre...
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Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs. Treated immediately with benadyl and extra water, followed by benadryl and tylenol 6 hours later and again 6 hours later. After approx 18 hours, my skin looked and acted like a sunburn reaction. After 24 hours I had chills. After 36 hours all symptoms were gone.
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| 71 | 2021-03-06 | pain in extremity | Left arm swollen Body ache Dizziness Increased joint pain |
| 71 | 2021-03-06 | tingling |
Pfizer-BioNTech COVID-19 Vaccine: During clinic visit eleven days after vaccination patient reports ...
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Pfizer-BioNTech COVID-19 Vaccine: During clinic visit eleven days after vaccination patient reports they started to experience diffuse paresthesias including tingling into face, arms bilaterally, hands, legs bilaterally, and feet. Started five days after getting vaccine. No other associated symptoms. No loss of muscle strength, slurred speech, shortness of breath, throat tightening, skin reaction such as rash or hives, or visual changes. No history of multiple sclerosis, diabetes, or thyroid disorder. Based on lab values patient advised to start vitamin B12 supplementation. Two days after clinic visit reported symptom improvement.
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| 71 | 2021-03-06 | muscle spasms |
Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burn...
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Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burning diarrhea, nausea, lack of appetite, more fatigue. Last symptoms hard to shake. Better and then back.
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| 71 | 2021-03-06 | tremor |
Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and...
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Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and shaking all over. Chills dissipated within about 4 hours. Had a very bad headache which also began about same time as chills and lasted for approximately another 12 hours, even though I took tylenol and advil alternating every 4 hours. Had a slight fever, approximately 1 degree over what I normally register for about 8 hours. I showered about 36 hours after vaccination and immediately broke out in a rash (not hives)...more like prickly heat all over my stomach, neck, chest, stomach, inside arms. This lasted until the next day; did not itch or cause any discomfort.
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| 71 | 2021-03-06 | pain in extremity |
approximately 24 hours after the shot i got sharp electric shock like pains under my right arm down ...
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approximately 24 hours after the shot i got sharp electric shock like pains under my right arm down near my ribs and towards my back. the pain became so bad i couldn?t move my arm. it was like that for 2-3 days and then got so i could move it but still had pain. a few days later i got a rash where the pain was and went to the dr the next afternoon and was told that i had shingles
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| 71 | 2021-03-06 | pain in extremity | soreness in upper arm, tiredness |
| 71 | 2021-03-07 | hot flush |
For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A ...
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For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A week after got hot flashes. Then sucsided During the second week I had an episode when I felt like fainting, Throughout the week I am increasingly tired to a level of total exhaustion and bewilderment. I have extreme reservations about taking the second shot as I never felt so extremely exhausted
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| 71 | 2021-03-07 | numbness, numbness and pain in extremities |
My symptoms from the gadolinium worsened after the vaccine. Increased neuropathy in extremities, lo...
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My symptoms from the gadolinium worsened after the vaccine. Increased neuropathy in extremities, loss of short term memory, tightness of skin on face, nose numb, sympathetic nervous system engaged, no ability to get out of fight or flight.
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| 71 | 2021-03-08 | feeling jittery, tremor | Anxious, Shaking, Jittery ,fast heart beat. ill at ease. |
| 71 | 2021-03-08 | bell's palsy |
Got shot at 3:30pm by 10:30pm had symptoms of bell palsy (eye sagged) On 3/6/21 eye and mouth sagge...
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Got shot at 3:30pm by 10:30pm had symptoms of bell palsy (eye sagged) On 3/6/21 eye and mouth sagged. Went to emergency room, was given Prednisone 50mg, still having problems with eye and mouth.
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| 71 | 2021-03-08 | paralysis | I got paralyzed .. could not stand on my legs ... I was wobbly |
| 71 | 2021-03-08 | pain in extremity |
Injection was not given in the deltoid but higher near the shoulder. Compared to 1st dose this one b...
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Injection was not given in the deltoid but higher near the shoulder. Compared to 1st dose this one burned. Told my husband it was too high(I am a retired CMA). The following Monday my arm started to hurt. By Wednesday I could not move my arm. I felt as I if I had bursitis in the shoulder. It has been more than 3 weeks and I am still having pain.
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| 71 | 2021-03-08 | tingling, numbness |
Pt. c/o numbness and tingling of the left hand and fingers. Pt. Seen and assessed by paramedics and...
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Pt. c/o numbness and tingling of the left hand and fingers. Pt. Seen and assessed by paramedics and vital signs are, BP 128/60, HR 68. Pt. observed for 30 min. and cleared to go home after verbalizing she felt a decrease in sensation. Pt. told to call MD if sensation worsens.
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| 71 | 2021-03-08 | pain in extremity |
The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. ...
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The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. It was a simple prick however I thought it seemed an odd location. About 24 hours later (Sun) I felt first signs of tenderness at the site but didn't think much of it as that is what I had heard from others about the vaccine. Later in the day it became achy. On Monday morning I noticed my whole arm was achy in addition to the top of my shoulder and the left side of my neck and upper shoulder blade. At 9:30 am I felt very tired and laid down and awoke 4 hours later! My aches were still all there as though I had slept wrong. Again I was not too concerned except that my friends all said their discomfort was gone within 24 hrs. Today is Tuesday and evening and as I sit here I have a very tender, sore, achy upper left arm and a small black and blue spot at the site. It's strange because it doesn't hurt when I touch it, instead it is just an ache/pain that I feel and especially when I move the arm. The tightness and ache in my neck and back and shoulder has lessened. I am reporting as I was not expecting this type of reaction especially to last 3-1/2 days so far. I feel this adverse reaction probably has more to do with the location that the technician chose to give me the vaccine. I am thinking the muscles are reacting to injection.
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| 71 | 2021-03-08 | pain in extremity |
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my ...
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Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
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| 71 | 2021-03-09 | muscle spasms, feeling hot |
About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her lef...
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About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her left hand started stinging all over. Both legs started getting a strange warm sensation, the size of a pea that kept getting warmer. She was not able to get up or open her eyes, doesn't know if she passed out but apparently went to sleep and slept for 3 hours and woke up and went to bed. She then had toe cramps on her left foot, then got up and walked around the bed and laid down again and fell asleep until the morning. She did not feel normal until 3/5/21. On Sunday, 3/7/21 had nausea, took something for that and the next day she was fine.
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| 71 | 2021-03-09 | tingling, muscle spasms, pain in extremity, discomfort, weakness |
After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses...
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After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses. 2nd night- chills, tiredness, sore legs, difficulty walking. 3/7/21- woke up with painful legs, heaviness, unable to walk, continued mild headache. treatment include: Tylenol, Gabapentin and lidocaine cream, avoiding narcotics rehab therapies
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| 71 | 2021-03-09 | flushing |
Patient experienced mild reaction following first dose of Pfizer COVID-19 vaccine, so she pre-medica...
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Patient experienced mild reaction following first dose of Pfizer COVID-19 vaccine, so she pre-medicated with 25 mg of oral Benadryl before coming for 2nd dose. Provider authorized administration with 30-minute observation to follow. Shortly after administration, patient experienced facial flushing, itching hands and tongue swelling. No difficulty breathing reported. Patient took second oral dose of 25 mg Benadryl (her own medication from home) with resolution of itching and significant improvement of flushing and tongue swelling. Patient stated 'much improved' prior to discharge. Follow-up call attempted next day to check on patient with no answer--message left to contact PCP office if any ongoing concerns. Second follow-up call: patient symptoms improved evening of immunization.
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| 71 | 2021-03-09 | tenderness |
Patient noticed below her right ear was tender and swollen. Pt states she still has about a 1.5 cm ...
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Patient noticed below her right ear was tender and swollen. Pt states she still has about a 1.5 cm lump in the lymph node that is firm. Pt states physician noticed some inflammation in the lymph nodes under both arm pits.
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| 71 | 2021-03-10 | feeling hot, tension headache, muscle spasms, numbness |
20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my fo...
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20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my forehead. I began to feel light as if my body was light. The Lead Monitor came over and had my blood pressure and oxygen levels checked over the next 40 minutes before I felt actually fine and able to walk out. At no point did I have trouble breathing although that question was repeatedly put to me. Then at home I took it easy but noted anything out of the ordinary. 1.5 hrs after the injection and lasting only 2 minutes, I felt like a band was being tightened around my head to the point of discomfort but not pain. 24 hrs after the injection, for less than one minute, my left temple felt pressure as if I had a head cold. I haven't had a headache in a decade so this was unusual for me. 10 hrs after the injection, I was awakened to by cramping from lower Achilles to foot in my right leg only. This lasted painfully for 12 minutes. My right foot itself felt numb. I would stand to stretch the muscle/ tendon but then immediately felt nauseous. I hate feeling nauseous so I would lay back down only to have to stand again due to the pain of the persistent cramping. This was 12 minutes of excruciating leg cramps. When usually I might have only one or two very brief leg cramps per year. 14.5 hours after injection, I awoke very thirsty adn my skin felt very dry. I drank water and applied hand lotion. Thereafter the vaccine site felt sore but the injection site would have been invisible but for the bandaid outline that narrowed down where the injection had to have been located. The vaccine site was never red or pink or raised at all. Just a pin prick if you really looked for it. As a follow-up, the second Pfizer dose was Lot EM9809 on Feb. 26, 2021, and I had no reaction at all. No visible injection site in right arm, no warmness, no light-headedness, no cramps, nothing at all happened.
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| 71 | 2021-03-10 | numbness, paralysis, facial pain, pain in extremity |
beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; fa...
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beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.
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| 71 | 2021-03-10 | weakness | chills, fever, body aches, headache, loss of appetite and no energy/tired |
| 71 | 2021-03-11 | pain in extremity |
12/10, 5:00 p.m. Loss of appetite, nausea (continued for next 18 hours), very sore right arm; 12/...
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12/10, 5:00 p.m. Loss of appetite, nausea (continued for next 18 hours), very sore right arm; 12/11, 3:00 a.m. Chills, all over body ache, headache, extreme fatigue, very sore arm; (continued for next 12 hours); 12/11, 12 noon, diarrhea, vomiting (one episode each); 12/12, 6 a.m. - 3 p.m. mild body ache, mild fatigue, mildly sore arm
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| 71 | 2021-03-11 | pain in extremity |
After first dose of vaccine, c/o chest pain, SOB, diaphoresis, BL arm pain, jaw pain. EMS was called...
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After first dose of vaccine, c/o chest pain, SOB, diaphoresis, BL arm pain, jaw pain. EMS was called and assumed care for transfer to hospital. Contacted patient 2 days after event and patient reports that she was feeling well. She notes that she was not actually transported to the hospital by EMS. She notes that she was evaluated in the ambulance. Since her EKG was normal, she states that she elected to be discharged home. She notes that she believes that she had an anxiety attack as she has events like this previously. She notes that she has discussed the event with her PCP. She is scheduled for 2nd vaccine on 3/20/21.
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| 71 | 2021-03-12 | pain in extremity |
Awoke 3/12 with pain in left back covering an area about 8" by 8", all on the ribs. Would not have t...
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Awoke 3/12 with pain in left back covering an area about 8" by 8", all on the ribs. Would not have thought it was related to the vaccine, except that the exact same pain showed up 2 days after I got the first vaccine, and I have never had it before. Lasted 3-4 days-faded away. (Did not report at that time - thought I had strained something.) Very painful, does not appear to be muscular, heat does not help. Hurts much worse with breathing in deeply, any movement. Also have pain in left ankle radiating up the inside of the leg, which I also had with the first shot and at that time attributed to new shoes, which had also gone away weeks ago.
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| 71 | 2021-03-13 | tremor | Chills, shaking, dizziness, fatigue, loss of appetite |
| 71 | 2021-03-13 | pain in extremity |
Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. ...
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Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. Had nausea meds and took one which calmed things down. Then at 3:00 AM on 3/13 2021 was hit with nausea again.. Took more meds for nausea and have been fine ever since. Developed overall Muscle Aches (not joint aches!) all day Saturday 3/13/2021. Still have some muscle aches today 3/14/2021. Left arm became sore on Saturday 3/13/2021 and whole left shoulder is sore today (3/14). Otherwise feel great!
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| 71 | 2021-03-13 | weakness |
intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I to...
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intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I took Tylenol Extra Strength tablets for the headache & muscle pain. The headaches lasted for 3 days. The muscle pain for 3 days. The vomiting occurred on the day after the shot - 1 time. I remained nauseous for the next 3 days. The chest pain has been on and off for the past 2 days. It has been mild. The lightheadedness lasted for 4 days. The lack of energy is still ongoing, but is getting better.
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| 71 | 2021-03-14 | pain in extremity |
Besides sore arm, chills, and fatigue, heart flutters were felt within 2- 3 hours of injection. Hea...
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Besides sore arm, chills, and fatigue, heart flutters were felt within 2- 3 hours of injection. Heart felt like it was skipping a beat and was continuous the rest of the day and night. Subsided gradually over the next 2 days after injection.
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| 71 | 2021-03-14 | numbness, pain in extremity |
I cannot move my pinky on my hand and my whole hand you know it feels like it is a nerve or somethin...
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I cannot move my pinky on my hand and my whole hand you know it feels like it is a nerve or something; I cannot think straight; the whole hand hurts; Hand of the arm where injection was placed is numb; a lot of pain; I could not move my thumb on my hand, very painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EN5318), via an unspecified route of administration on 04Feb2021 01:15 at a single dose in left arm for COVID-19 immunization. Medical history included hypertension/high blood pressure, diabetes. No other vaccine in four weeks. The patient was not a pregnant. Concomitant medication included atenolol, valsartan (DIOVAN) for high blood pressure, glimepiride for diabetes, gliclazide (GLIZA) for diabetes, insulin for diabetes. The patient had the first Covid shot (Clarified as Covid19 vaccine Pfizer) on Thursday (04Feb2021) and the next day (05Feb2021), the patient could not move her thumb on her hand, very painful. The patient experienced hand of the arm where injection was placed is numb and in a lot of pain on 05Feb2021. Now (06Feb2021), she cannot move her pinky on her hand and her whole hand you know it feels like it is a nerve or something. She did not know what it feels like and it is on the same hand as she got the shot. She cannot think straight. She believed it was later that night, going into the morning. Well, it might have been in the morning more. Probably in the morning and then the rest of the hand hurt me and now her pinky, the whole hand hurts. She cannot move it and it hurts that much. The patient underwent lab tests and procedures which included height: about 5'1, weight: about 200 lbs on an unspecified date. Adverse event resulted in none of the above. No treatment received. No known allergies. The outcome of events was unknown
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| 71 | 2021-03-14 | pain in extremity |
Received vaccine about 12:30pm 3/10/21. When I woke up next morning, besides arm being sore, there ...
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Received vaccine about 12:30pm 3/10/21. When I woke up next morning, besides arm being sore, there were hard welts about 1 inch from injection site. They were itchy and red. Over the past few days itching stopped, but the separate welts turned into one long 2 inch raised hard area. Still there 3/15/21
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| 71 | 2021-03-14 | pain in extremity, migraine |
Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach...
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Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach ache,
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| 71 | 2021-03-14 | weakness, tremor |
moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immedia...
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moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immediate dry throat and feeling of dehydration, stomach cramps followed by diarrhea about half hour after onset. Symptoms eased after 30-40 minutes so that I could get home and then diarrhea and weakness and shakiness for 3-4 hours. No epi pen administered because breathing was ok
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| 71 | 2021-03-15 | weakness, burning sensation |
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce...
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Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
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| 71 | 2021-03-15 | pain in extremity |
I am having increasingly bad pain in both arms, wrists, hands, knees, neck. My pain in especially ba...
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I am having increasingly bad pain in both arms, wrists, hands, knees, neck. My pain in especially bad at the injection site. The first shot on Jan 11 caused a terrible sore arm that only lasted a day, the second shot on Feb 1 caused a sore arm that lastsd 3 days, then this full body pain began and has not abated (45 days). The pain is spreading now to my quadriceps and my calf muscles and the pain seems to be mostly in muscles or tendons. Someone suggested I had RA but my joints (except wrists) are good. I'm taking Ibuprofen every 4 hours. I did a 5 day blast of 50MG prednisone about 3 weeks ago and that helped a lot, but pain is back and worse.
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| 71 | 2021-03-16 | tingling |
After waiting 30 minutes after my injection, I left the hospital and was driving home when I began t...
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After waiting 30 minutes after my injection, I left the hospital and was driving home when I began to feel my face tingling and swelling. This was close to 45 minutes after the injection. I was not sure what I was feeling, but had a similar reaction to the first Shingles shot so I was monitoring what I felt. I went to a walk in clinic about 2 hours after this feeling began. The swelling was on the right side of my face from a midline of my top lip to my right cheek. The doctor I saw told me to take Benadryl and gave me scripts for a Medrol Dosepak and epi pens. I took the Benadryl and got through the evening. I took Benadryl on Saturday and stopped it on Sunday. My face was still puffy, but no worse. Sunday night, my face felt worse and I took the Benadryl again. Monday morning, my face was slightly more swollen. I decided to start the Medrol Dosepak. My face was not feeling good and my throat felt like I was swallowing a boulder when I ate making me think that my throat might be closing up a bit. I decided to use the epi pen, gave myself the shot, got the shakes from the shot, and went to the emergency room as instructed on the pen. My blood pressure was very high arriving at the hospital which was from the epi pen. I was watched at the hospital, the epi pen had done it's work, and I went home 4 1/2 hours later. I have had continued puffiness in my face. I have been given Famotidine to add to the Benadryl as I had with the shingles vaccine reaction. This Wednesday after getting the shot on the previous Friday.
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| 71 | 2021-03-16 | weakness |
Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tired...
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Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tiredness, slight headache, injection site swelling and redness slight fast heartbeat,Light weakness
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| 71 | 2021-03-17 | weakness | Nausea weakness |
| 71 | 2021-03-17 | pain in extremity |
Patient reports she is a medical assistant, and that vaccine given to close to the AC joint. Patien...
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Patient reports she is a medical assistant, and that vaccine given to close to the AC joint. Patient now has bursitis. Significant pain in shoulder and arm. would like another dose of vaccine.
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| 71 | 2021-03-17 | pain in extremity | Soreness in arm, shoulder and neck |
| 71 | 2021-03-17 | tremor, weakness |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Medium
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| 71 | 2021-03-18 | flushing |
At 13:45 pt notified COVID-19 drive-thru vaccine station patient monitor that she was having facial ...
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At 13:45 pt notified COVID-19 drive-thru vaccine station patient monitor that she was having facial flushing. Dr. and RN responded to patient in parking lot to assess. Patient reported that she had a reaction after her first dose of vaccine, she "felt it in her body," and lightheaded, and it took 3 hours for it to feel better. She also said that when clinical staff assessed her last time, she did not take her mask off, so they didn't know that her face was flushed and swollen. She said that she had talked to her PCP who recommended that she bring Benadryl to take after the vaccine if she had the same reaction. Pt states that while in line for vaccine, someone told her she should take the Benadryl before the vaccination, so she took 50mg. VS: BP 128/82, HR 56, RR 20, SpO2 98%. Heart sounds regular, lungs clear to auscultation. Pt denies nausea. No rash visible. Clinical staff stayed with patient. Pt also said that she had history of anaphylaxis to eggs. At 15 minutes, symptoms not progressing, but also not lessening. At 14:12, because patient had taken Benadryl and staff was unable to tell if allergic symptoms were lessened by the Benadryl, they contacted EMS to come assess the patient. EMS arrived at 14:20, report was given. EMS assessed pt in ambulance. AT 14:44, EMS released pt to home. She reported that she felt better and thanked clinical staff.
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| 71 | 2021-03-18 | bell's palsy |
Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). ...
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Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) at the age of 71-years-old, intramuscular on left arm on 28Feb2021 at 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies, blood cholesterol abnormal (reported as cholesterol), and allergies to penicillin which were all ongoing. The patient was not pregnant. She has no COVID prior to vaccination and has no prior vaccination and other vaccines in four weeks. Ongoing concomitant medications included zileuton (ZYFLO CR) and budesonide, formoterol fumarate (SYMBICORT) for asthma; levocetirizine and azelastine hydrochloride, fluticasone propionate (DYMISTA) for allergies; immunoglobulin human normal (HIZENTRA); and atorvastatin (LIPITOR) for cholesterol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) at the age of 71-years-old, intramuscular on left arm on 02Feb2021 at 14:30 at single dose for COVID-19 immunization. The patient previously took aspirin and experienced allergy. The allergy was reported to be ongoing. The facility type where the vaccine was administered as reported to be other and mega-site. The patient experienced Bell's palsy left side of face on 01Mar2021 which required physician office visit. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1g, 3x/day. The outcome of the event was not recovered. The event was assessed as non-serious by the reporter.
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| 71 | 2021-03-18 | weakness, feeling cold |
Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; ...
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Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unspecified if 'EL9264' or '3L9264'), via an unspecified route of administration, on 09Feb2021 01:30PM at a single dose on the right arm for COVID-19 immunization. Medical history included thyroid disease (was diagnosed in her 40s, 30 years ago) from 1991, blood pressure high (was diagnosed in her 40s, 30 years ago) from 1991, mitral valve prolapse from 2001 (was diagnosed about 20 years ago), little heart disease (which she was told was nothing to worry about), her heart running away from her (They did extensive heart tests and pictures, all that stuff, put her on a medicine called Atenolol which makes her heart beat regularly and not have spells while she is walking of her heart running away), and double knee surgery three years ago (2018) when they put in false knees. Concomitant medications included levothyroxine sodium (SYNTHROID) for thyroid disease, atenolol (ATENOLOL) from 1991 for 'her heart running away from her' (She has been on atenolol 30 years, since she was 40 something. It is good medicine, and she doesn't have her heart running away.), tramadol (TRAMADOL) for double knee surgery three years ago (2018) when they put in false knees, and she also takes two high blood pressure medications. The patient added that all of the medications she takes she has been on about 30 years. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), on 18Jan2021 01:30PM on the right arm for COVID-19 immunization. The patient reported that she had received both doses of the Pfizer COVID-19 vaccine. She has been told that the AEs (adverse events) associated with the vaccine would happen within 12 hours. However, her AEs had been occurring in stages. On 10Feb2021, she had muscle pain. On 11Feb2021, she woke up and threw up and was in bed all day having fatigue. At the date of report, 12Feb2021, she was still on her bed, tired, and having chills. She wanted to know if it is normal to have these reactions 3 days after the shot. She further reported that she got the second dose. And after feeling wonderful after the first dose, she got the second dose on 09Feb2021 and later that night her lower back was killing her. She later clarified that she had low back pain. She stated that she knows that part of side effects that she read for when someone got the shot was that they can have a headache and she was told side effects should only last 12 hours. She stated that on the 11Feb2021, she woke up that morning and couldn't make it out of bed and vomited, then had to get up and clean her bed and put on new sheets. She only vomited once. She stated she has been so tired and lethargic that she stayed in bed all day on the 11Feb2021. At the time of report, on February 12Feb2021, she was having chills, she couldn't get warm, and she didn't have a fever, but she is still weak. Since she was told side effects would go away within 12 hours and this has been three days, she asked if what she was experiencing was normal. As for corrective treatment the patient reported that she also takes tramadol since she had double knee surgery three years ago (2018) when they put in false knees; that's when she started taking Tramadol for that. She said she also took it for the back pain which it kept it at bay until it wore off. Her lower back pain is already gone at the time of report; she was just having chills still and was tired. She stated she has had so many symptoms on different days that she was just questioning. She stated that everyone else who was sick with the second dose it lasted 12 hours, and her friends who really got sick with it, hers is minor, but she would like to know if it is normal that it is still lasting. Outcome of the event low back pain was recovered on an unspecified date in Feb2021. Outcome of the events weak, couldn't get warm, chills and tired was not recovered. Outcome of the other events was unknown. Information on batch number has been requested.
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| 71 | 2021-03-18 | weakness, pain in extremity |
Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on th...
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Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on the legs, arms, hands, and shoulder, sore legs, very weak, difficult to sleep.
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| 71 | 2021-03-18 | discomfort, weakness, difficulty speaking |
I woke up at 3am with pain in my shoulders.. Soon after I felt sharp pain in random places and times...
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I woke up at 3am with pain in my shoulders.. Soon after I felt sharp pain in random places and times in my body, and I would shake shortly at random time. As time went on the pain seemed to move down my body from my shoulders to my arms then my hands and then to my legs. I fell back to sleep for a couple hours and woke with sharp random short pains and continuing aching in my joints. I noticed my speech was gravelly. I had no appetite and did not eat at all that day. I mostly slept. When out of bed I felt very weak so was up for only short times. I took one alleve pill because I was so uncomfortable. I was not hot and did not have a fever. When I woke in themorning on 3/19/21 all that pain was gone and I felt very rested.
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| 71 | 2021-03-18 | migraine |
With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection. The next d...
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With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection. The next day, about 24 hrs. later I became very dizzy but didn't develop shaking, diaphoresis, or black spots in my vision. (I've had hypoglycemic episodes rarely, maybe every several years, but I know well what they feel like. No further episodes since then. I wasn't prepared for the episode and didn't have candy or orange juice handy. It required I lay down for 10 minutes while I was very shaky and cold, clammy diaphoresis. Pita Chips helped---I presume. Yesterday I received the second dose and 29 hours later I started getting hypoglycemic again but quickly drank some concentrated sugary lime juice. I remained slightly shaken but never developed black spots or diaphoresis. I still felt too light and shaky so I had another half glass of juice and feel normal after about 10 minutes. When I reported this, my daughter, who is an ER doctor, was doubtful the first time it was vaccine related because of the 30 hour gap. Before receiving the second dose, the doctor there also didn't believe it was related for the same reason. But I find it very odd now that after both vaccines, at around the 30 hour mark, I had the same effects. Except for a slight migraine- like headache, no other real symptoms----maybe some lethargy. I'm not diabetic, so I'm not on insulin or diabetic pills. I take a lower dose of blood pressure meds and have well-controlled hypertension. I can't even remember the last time (in years) I had hypoglycemia, but I've never had it as bad as I did the first time. Since I caught it this time with the juice and stopped the symptoms, I don't know if it would have reached the level of the first dose of vaccine.
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| 71 | 2021-03-19 | tenderness |
Swollen and very tender lymph node in left armpit midday 3/19. Increased as day progressed moving do...
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Swollen and very tender lymph node in left armpit midday 3/19. Increased as day progressed moving down to include elbow. Elbow tenderness, not swelling. Morning 3/20, Swelling spread to include inside upper arm. Tenderness increased from armpit to further toward back.
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| 71 | 2021-03-20 | difficulty speaking, weakness |
Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and...
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Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and very weak overall. Per order of a MD steroid dose pack taken as well as Benedryl 50 mg three times daily. Symptoms worsened, nauseated and temperature elevated 1.2-4 degrees above normal. Went to emergency room. Given intravenous solumedrol, Pepcid and Benedryl, then sent home on prednisone 40 mg a day for four days. Symptoms continued. MD took another steroid dose pack. Still worse after first four doses. Then took doctor's orders, prednisone 60 mg for three days, 40 mg for three days, 20 mg for three days then 10 mg for three days while continuing to take Benedryl 50 mg three times daily. I continue to take Benedryl for pink swollen cheeks. I am still weak and have swollen cheeks and neck as well as reduced voice.
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| 71 | 2021-03-21 | flushing, weakness |
Flushing, Excess moisture in eyes and mouth, strong metallic taste in mouth, weakness in knees, shor...
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Flushing, Excess moisture in eyes and mouth, strong metallic taste in mouth, weakness in knees, short vision disturbance. Symptoms subsided after an hour. Next day fluttering in chest. No trouble breathing
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| 71 | 2021-03-21 | one side paralysis |
Patient presented with frequent falls and left sided weakness with severe headaches for greater then...
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Patient presented with frequent falls and left sided weakness with severe headaches for greater then 24 hours.
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| 71 | 2021-03-21 | tremor |
Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection...
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Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection site, swollen nodes at injection site arm axilla
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| 71 | 2021-03-21 | pain in extremity, weakness |
Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasin...
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Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side, headaches, fever, sleep interruption, vivid dreams. The left arm which had been vaccinated was extremely sore and remained so, just recently lessening. I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so. I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
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| 71 | 2021-03-21 | weakness |
Within the 24 hours after I experienced an intense tightening of my back between my shoulder blades ...
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Within the 24 hours after I experienced an intense tightening of my back between my shoulder blades and more to the right side. It was painful breathing in fully, taking a deep breath, lesser so when I breathe shallowly. I felt very weak overall with multiple joints feeling pain (ankles, knees, wrist that was previously injured). The intensity of the back/between shoulder blades pain remained throughout the following day and a bit lesser so into day three (now).
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| 71 | 2021-03-21 | paralysis |
mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, ...
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mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, as well as tingling on 4 of the 5 fingers of her left hand; paralysis in her lips and gums all the way down to her finger tips on the side of the injection which was the left side; portion of the trigeminal nerve on the left side seemed to have been impacted; blood pressure had sky rocketed; This is a spontaneous report from a contactable physician and a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), lot no. EL9269, via an unspecified route of administration on 13Feb2021 at a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The physician asked if there were any reports of paresthesia around the gums and/or tingling in the hands and fingers. The patient received the first dose of the Pfizer COVID-19 vaccine. About 1 week after receiving the vaccine (20Feb2021), she experienced symptom complex, consistent with a mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, as well as tingling on 4 of the 5 fingers of her left hand, She was admitted and a full workup for central disorders and vascular disorders was negative (Feb2021). But her symptoms were continuing intermittently. She had numbness of the gums. A portion of the trigeminal nerve on the left side seemed to have been impacted. Also, peri-orally on the left side. The physician asked if this symptom complex has been reported and if there were reports of these mild sensory peripheral neuropathies coming from the vaccine. The physician stated that any info on dental paresthesia or any reports of other incidents of sensory paresthesia would be very helpful. The patient also called about the COVID 19 vaccine. On 13Feb, she got the vaccine in and then one week later on the following Saturday, the date would have been 20Feb, she started having a sensation of tingling and paralysis in her lips and gums all the way down to her finger tips on the side of the injection which was the left side and that has continued. She went to see the doctor the following Monday 22Feb and not knowing what it was, she sent her to the ER she was kept overnight, she was discharged 23Feb but her symptoms persisted even through today. These sensations were happening on average 3 times per day, sometimes many more anywhere from 3 minutes to 1 hour 45 minutes then it goes away. She did not go to her primary care. She confirmed her first dose was given 13Feb and the tingling and paralysis started the 20Feb it was still ongoing at this time. It has persisted but she can't tell whether it was getting better or not because sometimes it will last 3 minutes sometimes it will last 1 hour and 45 minutes. It started to effect other parts of her so she thinks it might be getting a little bit worse. It was starting to effect other parts of her body the progression goes, it started at the tip of her tongue and gums and then shortly within 30 seconds or less than a minute it spread to her upper and lower lip only on the left side and that was how it was on her gums as well it was only on the left side then she had the tingling in her finger tips on the left hand. She specified that she experienced these sensations on the tip of her tongue, left gums, lower left lip, and into the fingers on the left hand. She would like to know if these symptoms have been reported in association with the vaccine and if so, how long she can expect them to last. She stated that yesterday, a physician called in on her behalf for more information and said he received literature from 29Jan regarding reports that included information about dental paresthesia after the vaccine. She was planning not to get the second vaccine. She was not taking medications, she was in good health she did go and was admitted in the ER, they did a work up. Her blood pressure had sky rocketed on Feb2021 and since she mentioned sensation they ruled out a stroke. On Feb2021, they did blood work, MRI and CT scan and everything was they did not find anything linking to a stroke. She spent the night in observation. She was in the ER, they did put her in the main hospital but it was for observation from the emergency room. She went in on the 22Feb and was discharged home on 23Feb. She asked where this goes from here, these symptoms were concerning to her. She did not find any incidences at least in general of reporting this, asked if there were these kinds of things being reported, she didn't know how long it was going to last or if it will get worse. The outcome of blood pressure had sky rocketed was unknown while outcome of other events was not recovered.
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| 71 | 2021-03-22 | facial pain | FLU LIKE SYMTOMS, EXTREME PAIN IN NECK, EAR AND FACE |
| 71 | 2021-03-22 | muscle spasms | Left leg and hip charleyhorse and pain standing up |
| 71 | 2021-03-23 | weakness |
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ...
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15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
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| 71 | 2021-03-23 | migraine |
First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next d...
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First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next day, low fever, nauseous. Today, March 24, 2021, I have a bump under my left arm - swollen lymph node. Arm is still very red. , I was very fatigue d next day.
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| 71 | 2021-03-24 | flushing, feeling hot |
Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing cli...
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Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing client. Vitals were taken (180/90; 97% RA; hr 97. Client was given water and a fan was placed near pt. Client then began to complain of chest discomfort and burning in her throat like heartburn. She also began to feel nauseous. The dizziness began to get better. The client initially began to say she was feeling better, a couple minutes later she began to complain of chest pain/pressure. She described it as an elephant sitting on her chest. She also stated that her left shoulder began to hurt. She was also pale. Her vitals at this time were bp of 170/85; 02 of 97%; hr of 78. 911 was called at 4:10pm and arrived at 4:15pm. Chest pain was down to a 4 and nothing of significance was noted by EMS on the heart monitor. Client was given the option to be taken to the ER and she consented to transportation.
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| 71 | 2021-03-24 | tenderness |
Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feelin...
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Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feeling (slight nausea and headache). Got out of bed at 5 AM with headache still present. Fever of 99.4 about 7AM. Headache continued on and off all day with 2 Tylenol. Fever went down but rose to 99.4 approx. 8PM no headache. Woke today, Thursday, at 5 with no headache but a fever of 100.4; went back to bed until 6. After a shower, my temp was down to 99. After exercise, it was 98. Feeling okay right now.
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| 71 | 2021-03-24 | weakness |
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o...
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Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
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| 71 | 2021-03-24 | tremor |
EUA Pfizer-BioNtech vaccine reaction Patient complained 10 min after vaccine of shortness of breath....
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EUA Pfizer-BioNtech vaccine reaction Patient complained 10 min after vaccine of shortness of breath. she was visibly shaking , she was speaking normally but difficulty breathing.
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| 71 | 2021-03-25 | numbness | Headache Numbness in jaw and lips |
| 71 | 2021-03-25 | pain in extremity |
Sore arm, 3:00 pm date of vaccine, mild soreness remains 2 days later; chills and fever began approx...
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Sore arm, 3:00 pm date of vaccine, mild soreness remains 2 days later; chills and fever began approx. 11:00 pm date of vaccine (T 99.8), fever 101.2 and 101.3, down to 99.5 with 2 Tylenol day after vaccine; chills lasted an hour; fever broke about 1:30 am 2nd day after vaccine. Temp normal 2nd day after vaccine. Mild fatigue 2nd day after vaccine.
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| 71 | 2021-03-25 | hot flush |
heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day...
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heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day after the vaccination; 6th day after the shot she had hot flashes and swelling; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 as SINGLE DOSE for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history included allergies to penicillin and some other things. There were no concomitant medications. The patient experienced heart fluttering and dizziness 2nd day after the vaccination; repeated 3rd day after the shot; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness. All events started in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given for the events. The outcome of all events was unknown. Information on the lot/ batch number has been requested.
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| 71 | 2021-03-26 | feeling hot |
tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to E...
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tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to ER
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| 71 | 2021-03-27 | tingling |
3 min past vaccine tongue tingling, then roof of mouth and lips tingling, then face. Light headedne...
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3 min past vaccine tongue tingling, then roof of mouth and lips tingling, then face. Light headedness . Anxiety. Admin Benadryl. Will notify PMD of reaction
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| 71 | 2021-03-27 | weakness |
At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and procee...
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At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and proceeded to start vomiting. Around 7 am I began having uncontrollable diarrhea with weakness and dizziness following. No fever, just flu-like symptoms. With rest and liquids by mid-day I was starting to feel a little better.
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| 71 | 2021-03-27 | tremor | Headache, fever (101 degree) , violent shaking, and exhaustion; lasted about 36 hours. |
| 71 | 2021-03-27 | nerve pain |
Nerve pain in left leg. Moves around. Sometimes it is in the ankle area, sometimes below knee, somet...
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Nerve pain in left leg. Moves around. Sometimes it is in the ankle area, sometimes below knee, sometimes lateral side of calf, sometimes groin, sometimes lateral side of thigh. It is never in the joints. Sometimes stabbing pain, sometimes sharp ache, sometimes dull ache, sometimes searing pain or burning, sometimes icy cold. Sometimes it is mild 2 or 3/10; sometimes medium 5 or 6/10 at times it has been at least 9/10. It can feel good one minute and then be very painful without any movement or other change in position within 10 minutes. Sometimes responds well to NSAIDs, sometimes it does not. Almost always feels better in the AM before getting out of bed. Can be very painful within minutes of getting out of bed.
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| 71 | 2021-03-27 | burning sensation, difficulty speaking |
On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eat...
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On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eaten that morning: mashed potatoes, milk, cream of wheat - Throughout the day, patient notes she was not feeling well. At 6 PM, she developed rashes on her hip, groin, and abdomen. At 7 PM, she took diphenhydramine 25 mg. By then, her mouth was swollen. Her tongue also started to swell. At 9:30 PM, she had increase itching, burning sensation, and hives worsened. Developed a large rash on her butt. At 10 pm, took a second diphenhydramine; notes she had tongue swelling voice changes (gravel-like quality), and bilateral facial swelling. She was also breathing rapidly. Went into the ER, was checked in after ~3 minutes. She was administered epinephrine IM, IV diphenhydramine, solumedrol 125 mg, and IV famotidine. Patient was also intubated for respiratory distress and airway swelling, and admitted to the ICU. Was intubated until the afternoon of the following day.
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| 71 | 2021-03-27 | night sweats |
Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 day...
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Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 days I had body aches, extreme chills, night sweats and nightmares, explosive diarrhia, extreme fatigue (slept 23 hours a day). Each following day I slept a little less, but the night sweats and fatigue lasted for 17 days. My temperature remained around 95.7. This is the sickest I have ever felt, even sicker than the Flu I had approximately 30 years ago! No reaction to 2nd vaccine!
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| 71 | 2021-03-28 | tingling, weakness |
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel...
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Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
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| 71 | 2021-03-30 | pain in extremity |
Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the se...
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Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the second dose that I am getting palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (Batch/Lot Number: EH9231) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Mar2020 to Mar2020. The patient had the covid virus in Mar2020. The patient's concomitant medications were not reported. It was reported that she has a question, if a person had the covid virus earlier last year is it still okay to get the Covid vaccine. The first dose was given 13Jan2021. The patient had the covid virus in Mar2020. Caller clarifies that she is actually the patient in this case, and she is speaking about herself. Caller had the covid virus on Mar last year, relatively mild infection. She received the Pfizer vaccine last 13Jan2021. She spoke to a nurse last week since she started experiencing side effects, and was wondering if it was safe that she got vaccinated in the first place considering she had the covid disease prior. Caller mentioned experiencing side effects after the first dose of the vaccine, including severe headache, fever reaching 99.7F, chills, and pain in the arms (akin to getting the flu vaccine but worse). These symptoms have calmed down in a couple of days. She talked to her HCP about this who gave her tylenol but apparently did not do much in managing it. She wants to know if these side effects were expected from the vaccine. Patient was a bit nervous in getting the second dose that I am getting palpitations. Outcome of the events was unknown.
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| 71 | 2021-03-31 | depressed level of consciousness, seizure | Her husband called to report that he could not arouse her on 3-28-21. Advised to call 911. |
| 71 | 2021-04-02 | pain in extremity |
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur...
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Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
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| 71 | 2021-04-03 | weakness, one side paralysis |
Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhau...
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Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhaustion. Weakness was extreme in my whole left side and could barely put weight on the left side. I thought this would pass so tried to get along. The next day, Saturday, March 13, the complete exhaustion was even worse. Trying to get out of bed was very hard. I called a friend and went to hospital here . I was admitted, tested, and kept for several days. The report came back that I had a series of "mini" strokes on the right side of my brain, affecting the left side of my body. I could no longer walk at all without aide of person or a walker, After that I was taken to rebab, . I was given pt, OT, etc, and discharged several days later. No doctor or staff could tell me whether this was caused by the vaccine but the close days of administering the vaccine and the sudden onset of symptoms make me very concerned. How can I take a 2nd vaccine without knowing if that will have a worse effect or kill me? Can I take a different vaccine for the 2nd round, without a risk of something worse happening? Can you report to me if there is any correlation at all between this vaccine and my mini strokes?
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| 71 | 2021-04-03 | pain in extremity |
had little sore arm; This is a spontaneous report from a contactable consumer (patient). A 71-years-...
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had little sore arm; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:00 (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation. Medical history included High Blood pressure, arthritis and heart problems (Both of her parents had heart problems) from an unknown date and unknown if ongoing. The patient received unknown concomitant medications. The patient experienced had little sore arm on an unspecified date and used ice on it. The patient underwent lab tests and procedures which included weight: 46 lbs on it was intentional. The outcome of the event was unknown.
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| 71 | 2021-04-03 | muscle spasms |
upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spont...
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upper gastric pain/terrible stomach pain; continuous diarrhea; experienced cramping; This is a spontaneous report from a contactable Nurse, the patient. A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot number unknown), via an unspecified route of administration on 18Feb2021 as a single dose in the arm (reported as "deltoid") for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date. The patient responded "yes" when asked if she had been diagnosed with COVID-19 prior to the vaccination but also provided no details about this. The patient's concomitant medications were not reported. The patient experienced upper gastric pain/terrible stomach pain on an unspecified date with outcome of unknown, continuous diarrhea on an unspecified date with outcome of unknown and cramping on an unspecified date with outcome of unknown. The patient provided further details in that she reported that she woke the following morning after receiving the COVID-19 vaccine feeling as if she was having a heart attack, which was determined to be a result of upper gastric pain. She reported that she has experienced cramping and continuous diarrhea and she has been unable to leave the house except to receive medical treatment. She stated that she had had lab work (blood and stool samples) and everything has returned negative. She believes that the gastric pain and other symptoms are a result of her receiving the vaccine. She remarked that she works in healthcare and has been tested every week for COVID-19 prior to receiving the vaccine, and has not had any gastric pain issues prior to receiving the vaccine, never had any problem with her stomach, pain, diarrhea or anything related to diarrhea and stomach pain. The patient underwent lab tests and procedures which included stool culture negative on an unspecified date and "BMP, CMP and Hemoglobin - things like that" on an unspecified date the results of which were reported as "good" and SARS COV 2 test: negative on an unspecified date prior to this vaccine. Unspecified therapeutic measures were taken as a result of the events. Treatment for the events was reported as "just Tylenol."
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| 71 | 2021-04-09 | feeling hot, weakness |
2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I wa...
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2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I was ok I told her that I needed some water. When I was drinking the water I was having problems swallowing. Then I started having problems breathing. I then broke down on a rash my skin was so red it looked like I was sun burned. My skin also peeled. Then I was taken into the emergency room by ambulance. They put an IV on me when I got to the hospital. They put a steroid & pepcid famotidine. They told me if I was not better by the next day to go back. My voice also goes occasionally & I still don't have energy.
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| 71 | 2021-04-09 | slurring |
Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan...
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Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan. All came back normal. March 26, MRI done. That showed a stroke. Then on March 31st, saw Drs. (neurologist). Confirmed the stroke and suggested Speech Therapy. Starting on April 19, Sppech Therapy begins. Since Stroke, I have to sleep 12-15 hours a day.
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| 71 | 2021-04-11 | electric shock sensation, pain in extremity |
About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my rig...
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About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my right hand, starting at the knuckles down to finger tips. Pain occurred with or without movement. Knuckles are swollen on that On day 4, pain moved from knuckle to the joint between knuckle and finger tip. Pain occurs mostly with movement but not always, and is from mild to moderate pain. It is day 16 post vaccine, and I still have intermittent pain in the 3 fingers where I hadn?t previously had any prior to vaccine. 30 hrs after 2nd vaccine, I also had a severe headache lasting about 1 1/2 hrs.
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| 71 | 2021-04-16 | pain in extremity |
Patient developed what I though was Raynaud's in right hand. Later that day began having pain. I adv...
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Patient developed what I though was Raynaud's in right hand. Later that day began having pain. I advised her to go to ED. Evaluated in ED and felt to have Raynaud's as well. Approximately 36 hours later developed severe pain in right arm. Went back to ED and CT scan showed thrombus extending from Aortic arch to subclavian artery and down brachial artery. Underwent emergency surgery to remove thrombus.
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| 71 | 2021-04-19 | facial pain, numbness |
photo sensitivity to left eye odd numbnes/pain in cheek bone below left eye. Now blind in left eye ...
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photo sensitivity to left eye odd numbnes/pain in cheek bone below left eye. Now blind in left eye with drooping eyelid.
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| 71 | 2021-04-21 | numbness, pain in extremity |
Patient reports she started to have RT arm and shoulder pain after the injection, which was expected...
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Patient reports she started to have RT arm and shoulder pain after the injection, which was expected side effect, so patient did not report to the clinic. However, the pain did not go away over 3 weeks and it started to spread to RT upper back and shoulder and patient also started to feel numb in the area. Patient came to the clinic on 04/22/2021, reporting this is about 1 month and problem persists. Patient is referred out to nuerologist visit, and is prescribed for gabapentin 100mg BID. Will follow up in 2 weeks again.
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| 71 | 2021-04-24 | weakness |
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th...
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She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-04-24 | electric shock sensation, muscle spasms |
severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touc...
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severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touch; severe pain in her head, it hurt to touch and had shocks and her whole body would cramp up; her whole body would cramp up; Tourette's; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198, expiration date: 30Jun2021) at the age of 71-years-old, via an unspecified route of administration in right shoulder on 05Mar2021 at 10:30 at single dose for COVID-19 immunization. Medical history included neuropathy in feet caused Tamoxifen (chemotherapy), anal cancer stage IV, breast cancer, double mastectomy, chemotherapy, and lymph node in left arm. Concomitant medications included gabapentin, meloxicam, and vitamins. There were no additional vaccines administered on the same date with the COVID-19 vaccine as well as within 4 weeks. The patient previously took tamoxifen as chemotherapy and experienced neuropathy in feet. The patient received her first COVID-19 vaccine on 05Mar2021 and on 13Mar2021, she experienced severe pain across the front of her stomach. On 19Mar2021, she said she has something, and it was a rash. She went to care facility on 20Mar2021 and was told she has shingles. The patient stated that the doctor just looked at her and said she has shingles, no testing was done. They told her it was ok for her to get the second shot, but she was worried about that. She experienced shingles since 13Mar2021, she still has it. She was supposed to have the shingles vaccine 4 years ago, but it was expensive. Her son heard on the radio that the shot may cause shingles, it may or may not be related but she wanted to let Pfizer know. The rash was starting to go away, and the pain was not, but the pain was far better. She ended up going to the doctor on 24Mar2021 with severe pain in her head since Mar2021, and she didn't know why. It hurt to touch and had shocks and her whole body would cramp up. Her daughter told her she looked like she had Tourette's, it was happening every 2-5 minutes. The doctor couldn't do anything and told her what she could take. It was an additional thing and the doctor said it was probably from shingles but she did not have a rash there. It was completely gone now. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date: 31Jul2021), via an unspecified route of administration in right shoulder on 26Mar2021 at noon and stated that it was getting better then, and by 27Mar2021 it was gone completely. She was petrified this was going to happen while she was there to get the second vaccine and they would say she couldn't do it. The outcome of the event shingles was recovering and recovered on 27Mar2021 for all other events.
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| 71 | 2021-04-27 | pain in extremity |
Dizzy; Blood pressure systolic high; headache; extremely tired; sore arm; This is a spontaneous repo...
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Dizzy; Blood pressure systolic high; headache; extremely tired; sore arm; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284 Expiry date: 01Apr2021), via an unspecified route of administration, administered in right arm on 28Jan2021 around 03:30 PM (at the age of 71-years), as a single dose for COVID-19 immunisation. The patient got her COVID-19 Vaccine in her right arm because she had her lymph nodes removed on her left side due to left-sided breast cancer. Medical history included Seizure (She had a seizure at age 6, again at 12, both times she was told that seizures were because of a high fever. She said she was given phenobarbital at the time. She said her tests always showed something was abnormal. She said her next seizure was in her 40s and she had an MRI, and nothing was there. Patient was started on medicine and sent to a neurologist. Patient said she went through lots of medicines and either had a reaction, or the medicine did not control her seizures. In 1998 seizure at her doctor office, and the doctor had to do CPR on her, and then had an ambulance taken her to the emergency room. Patient had a vagal nerve stimulator implanted for seizure control in 1998 and she has a lead that goes to her head and neck, and a battery in her right shoulder). Stroke (In 12Feb2002 that was caused by hormone medicine & seizure medicine that interacted with each other at 52 years old and was hospitalized for 4 months, needing physical therapy, speech therapy, and a couple other types of therapy), Total hysterectomy (in Dec2001, she was started on a hormone pill after her total hysterectomy and hormone pill interacted with a seizure medicine she was taking at the same time, and caused her to have a major stroke on 12Feb2002), Diabetes (2009), TIA (2009), Left-sided breast cancer (From Dec2015 and will make a decision to continue with cancer medicine, anastrozole 1mg takes at supper. Mfg. Zydus Pharmacy NDC: 68382-209-06, GTIN: 00368382209061, SN: 30100085636501, Lot: M009071, Exp: 30Jun2022), Lymphadenectomy, patient had unspecified allergies in the past from medicines and ongoing triglycerides that are out of the ballpark. Patient got her regular flu shot in either Oct2020 or Nov2020. The patient concomitant medications included Anastrozole, Jaediance, Vascepa and Prolia. Patient was taking Jardiance 10mg pill once in the morning at breakfast, for about 2 years, dispensed in a (Pharmacy Name Withheld) pharmacy bottle with no NDC, Lot, and Expiration Date, and the manufacturer is listed as Boehringer Ing on the prescription label. Patient was taking Vascepa 1gm capsule at dinner time daily, and after 3 months of taking Vascepa, her triglycerides are down to 190. She said she started Vascepa 1gram capsules about 1 to 1-1/2 years ago that was dispensed in a (Pharmacy Name Withheld) pharmacy bottle with no NDC, Lot and Expiration Date. She said the manufacturer is Amarin Pharma 1 as listed on the Vascepa 1gram prescription label. Patient couldn't take 2 Vascepa 1gram capsules because she was in too much pain. Patient was taking Prolia injection done twice a year from three years at her doctor office for osteoporosis. On 28Jan2021 (same day of vaccination), patient was immediately dizzy, sat down and the room was spinning, they checked BP and it was up to 180, unknown what was bottom number. They moved me to a separate room and continued to check my BP. Patient walked with a nurse to another chair, and the nurse checked back with her after 5 minutes, and she got even worse. The nurse checked her blood pressure on her right arm, and her top blood pressure number had jumped to 180. Later moved to a private room with a recliner where nurse continued to monitor her every few minutes. Nurse called an emergency room doctor around 3:30PM to see if she needed to be transferred to the hospital emergency room. The emergency room doctor told the nurse to continue monitoring her where she was, and as long as her blood pressure did not go any higher, or nothing else happened, she could go home. Patient blood pressure went down to 130 and she was released from the COVID-19 Vaccine waiting area at 5:30PM. Patient experienced a headache and was extremely tired and had a sore arm. Patient spoke to one of her doctors and they mentioned having the Moderna vaccine for her second dose and one of her doctors told her to take the second COVID-19 Vaccine dose, while another doctor told her not to get the second COVID-19 Vaccine dose. Patient asked if she should get her second vaccine dose if she experienced a reaction to the first also if her BP will go up again with the second vaccine dose because she was afraid it will do it again and asks whether she should take the Moderna instead. Patient asked if she still need to stay away from my new grandson, should wait 21 days after first dose, and should still wear a mask or she was protected. Patient stated that according to nurse, she was only the second person to have that kind of reaction. Patient informed nurse that she was diabetic, but she does not take insulin. She said her last Hemoglobin A1C was 6.4. Patient wanted to visit a cardiologist because she has a big family history of heart problems and though never had a heart attack, but she is always concerned because her triglycerides are out of the ballpark. She clarified that a normal triglyceride level is 150 and her triglycerides were staying over 300. Patient lab tests included blood pressure (180, later came down to 130), triglycerides (over 300) on 28Jan2021, cholesterol and Haemoglobin (6.4) on an unspecified date. The patient did not take any other vaccine on that same day, as well as four weeks prior vaccination. The patient had hoped to get the Moderna COVID-19 Vaccine. She said her primary care doctor told her to take the Moderna COVID-19 Vaccine, but she couldn't find anyone who she could register with. The outcome of the events dizziness and systolic blood pressure increased was recovered for and unknown for all other events.
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| 71 | 2021-04-27 | weakness |
lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated;...
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lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-04-28 | discomfort, pain in extremity |
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain...
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muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
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| 71 | 2021-04-30 | tenderness |
noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remem...
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noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.
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| 71 | 2021-05-04 | pain in extremity |
Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable con...
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Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right deltoid on 18Feb2021 (Batch/Lot Number: ENb298) as a single dose for COVID-19 immunization. Medical history included diabetes-onset date: years, stroke on 12Feb2002, breast cancer in Dec2015 and cholesterol, headaches, restless legs. Concomitant medications included rosuvastatin calcium (ROSUVASTATIN CALCIUM GENERIC) taken for cholesterol from an unspecified start date and ongoing; tocopherol, ubidecarenone (COQ-10 ST) taken for cholesterol from an unspecified start date and ongoing; gabapentin enacarbil (HORIZANT) taken for headaches, restless legs from an unspecified start date and ongoing; anastrozole (ANASTROZOLE) taken for an unspecified indication from an unspecified start date and ongoing; empagliflozin (EMPAGLIFLOZIN) taken for an unspecified indication from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication from an unspecified start date and ongoing; denosumab (PROLIA) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose, lot number: EL1298) on 28Jan2021 for COVID-19 immunization and experienced blood pressure systolic high and dizziness. The patient felt extremely tired on an unspecified date and was hospitalized for about a week (7 days), had a sore arm on an unspecified date and was hospitalized for 2 days and experienced muscle pain on an unspecified date. No treatment was administered for the event extremely tired, for the muscular pain Tylenol was taken starting 24 hours after shot - stayed in shot area. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-05-09 | seizure |
This 71 year old female received the Covid shot on 2/27 /21 and went to the ED on 3/3 /21 a...
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This 71 year old female received the Covid shot on 2/27 /21 and went to the ED on 3/3 /21 and was admitted on 3/4/21 with the following diagnoses listed below. R56.9 - Unspecified convulsions
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| 71 | 2021-05-10 | slurring |
H/o meningioma and left ICA occlusion w/ prior traumatic ICH sent from outpt clinic s/p 2nd covid va...
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H/o meningioma and left ICA occlusion w/ prior traumatic ICH sent from outpt clinic s/p 2nd covid vaccine with acute onset slurred speech, facial asymmetry and LUE weakness (?chronic), atraumatic, nml AC, pt HD stable, stroke alert on arrival, symptoms improving
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| 71 | 2021-05-12 | numbness |
This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT...
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This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 20Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included allergies to Nitrofuradantoin from an unknown date and unknown if ongoing. Concomitant medication included probiotics (PROBIOTICS), ergocalciferol (CALCIFEROL VIT D), ascorbic acid, biotin, calcium, equisetum arvense stem, ferrous fumarate, nicotinamide, panicum miliaceum seed, proteins nos, shark cartilage (VIVISCAL ADVANCED HAIR HEALTH) and colecalciferol, ubidecarenone (COQ10 + D3). The patient reported that, after approximately 10 min after receiving vaccine her lips and tongue became numb. Slight throat constriction and heaviness in chest -15min later. The patient stated that, she got the 1st dose on Saturday, 20Feb2021. While she was there waiting after she got her injection, about 10 minutes, all the sudden her mouth and tongue became numb. So, she called the EMS guy over and asked him if she was having a reaction, he said that it probably was and asked her if she felt like her tongue or throat was swelling. States that she did not feel like they were swelling, but she did feel a little constricted in her throat. Stated that she still has the numbness, though it was a little less in her lips, but now her right cheek was numb on 23Feb2021. The patient experienced right cheek numbness on 23Feb2021, after approximately 10 min after receiving vaccine my lips and tongue became numb on 20Feb2021 16:10 with outcome of not recovered on 20Feb2021 16:10, slight throat constriction and heaviness in chest -15 min later on 20Feb2021 16:25. The event was assessed as medically significant. The patient was not tested for COVID-19 since the vaccination. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Hypoasthesia,Throat constriction,Chest discomfort.. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 71 | 2021-05-13 | night sweats, tremor |
I also woke up in the evening drenched with sweat and chills, completely sweat; I also woke up in th...
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I also woke up in the evening drenched with sweat and chills, completely sweat; I also woke up in the evening drenched with sweat and chills, completely sweat; shaking so badly; I was that sick; First shot was February 25, the second shot was April 22nd; First shot was February 25, the second shot was April 22nd; have anaphylaxis at 30 minutes/probably something in the medication that she was allergic to; This is a spontaneous report from a contactable (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number reported as EDOL71/ENOL71, unsure) via an unspecified route of administration on 22Apr2021 12:15 pm as 2nd dose, single for covid-19 immunisation. Medical history included shortness of breath, asthma. Concomitant medications included albuterol (SALBUTAMOL) and budesonide/formoterol fumarate (inhalation aerosol). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Feb2021 at the age of 71 years for covid-19 immunisation and she did fine. Patient stated that lot number for shot 2 looked like EDOL71. It could be ENOL71. The lady didn't write it very well. It could be EN or ED. She was calling to report she had a terrible side effect and she want to document it in the data. She couldn't give that to computer right now, she didn't feel well, she had the Pfizer shot 1 and Pfizer shot 2. She had anaphylaxis at 30 minutes and almost she had crashed her car just after the highway. First shot was February 25, she did fine, the second shot was April 22nd and she had a horrible reaction at 30 min. Patient stated that the problem is they didn't asked her if she was short of breath or if she had any pulmonary complication and so on the second shot she didn't say anything and she forgot to say she has asthma and no one asked her. she forgot to say and so they had her sit in 15min observation and she was fine and she had gone out after she got her vaccination record card sign, she got in her car and 15min. Later while she was driving she went into anaphylaxis. She had to pull over, thank god she didn't hit anybody, she pulled over and parked and she had her inhaler with her so she used the inhaler and she got in the back seat for half an hour to make sure that she drove home, she did not call 911. Patient further stated that she wanted to put it in documentation, if someone is taking something for asthma that probably should not have the second shot one medication is not good enough, the second dose and she also woke up in the evening drenched with sweat and chills, completely sweat and that happened about 8 to 10 hours after the shot on 22Apr2021. After the shot at 12:15 pm and she had the sweat about 11 O'clock at night when she had to lay down and she was shaking so badly she thought she was going to call 911, she was that sick. That's scary, patient stated "I must, I did have crashed in 3 or 4 people during that." So, it was very dangerous to someone who has asthma. That was probably something in the medication that she was allergic to. Outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylaxis.
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| 72 | 2021-01-04 | pain in extremity |
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul...
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arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
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| 72 | 2021-01-05 | weakness |
she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a con...
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she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 29Dec2020 09:00 at a single dose in the left arm as COVID-19 vaccine. Medical history included blood pressure high (diagnosed a while ago at the time of the report), and she has been taking a medication for it for years. There were no concomitant medications. Patient said she had no new medications or other vaccinations administered with this vaccine. On 29Dec2020 22:00, he patient had a reaction where the room was spinning and she got very dizzy. She would like to know is that normal, since she has to go back for a second shot. She was given the vaccine by a nurse at the hospital she works as technician at which is not a military hospital. She said that the hospital is giving the vaccine to its employees. She got the vaccine yesterday morning around or after 09:00AM, and she was ok during the day. She said that the room spinning started before she went to bed at about 10:00PM, and when she got to her room she noticed everything was moving around. She said then she fell asleep, and it was better today, the room was not moving, she just felt very weak now (30Dec2020). Patient said as her treatment for room was spinning and she got very dizzy was that she fell asleep. The events room was spinning and she got very dizzy were recovering. The outcome of the event felt very weak was unknown.
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| 72 | 2021-01-07 | pain in extremity |
Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; E...
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Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
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| 72 | 2021-01-07 | weakness |
she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; ti...
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she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7°F-102.2°F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 72 | 2021-01-09 | pain in extremity | Sore arm |
| 72 | 2021-01-13 | feeling cold, pain in extremity |
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to...
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Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
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| 72 | 2021-01-14 | numbness, tingling |
At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has con...
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At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has continued with occasional spreading to nose & eyes & sometimes on other side of face - it waxes & wanes Same day - headache, dizzy, exhausted - lasted 2 days Next day - nausea, intestinal discomfort - continuing mildly Mild headache continuing
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| 72 | 2021-01-15 | feeling hot | swollen neck near collar bone on left side.hot, |
| 72 | 2021-01-17 | pain in extremity, weakness |
After waking in the AM of the following morning after vaccination, felt total exhaustion and weakne...
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After waking in the AM of the following morning after vaccination, felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide. Able to lie down and sleep for about an hour; awoke and felt better. Took two 200mg ibuprofen and laid down again. Within an hour of rest, felt awake with no weakness or exhaustion. Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
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| 72 | 2021-01-17 | grand mal seizure |
Patient had vaccine on 1/6/21 and have three grand mal seizure on 1/12/21. She was hospitalized an...
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Patient had vaccine on 1/6/21 and have three grand mal seizure on 1/12/21. She was hospitalized and return to facility on 1/15/21. Patient does has history of seizure but the last one was three years ago.
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| 72 | 2021-01-19 | discomfort |
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heavi...
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Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain, appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
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| 72 | 2021-01-19 | tingling |
Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation perio...
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Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation period post-Pfizer COVID-19 vaccine (Lot # EL1283). Diphenhydramine 25 mg PO administered. No additional symptoms observed. Patient discharged ambulatory in NAD.
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| 72 | 2021-01-22 | flushing | Rapid heartbeat, rash, hives, itching, felt flushed, no fever. I still have mild symptoms. |
| 72 | 2021-01-23 | pain in extremity | sore arm, slight fever, extreme fatigue. lasted most of the day and they are gone now. |
| 72 | 2021-01-24 | weakness |
1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after t...
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1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down. Went to family doctor 1/22 and covid shot in office showed negative. Worse on 1/24/21 and went to ED. They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results. All was negative except the D-dimer test. Thye thought it might be a result of the 2 injections within days of each other.
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| 72 | 2021-01-24 | seizure | brought by EMS to ED; seizures at home in bed; 6 Epi and 1 bicarb; no hx of seizure |
| 72 | 2021-01-24 | pain in extremity |
chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after re...
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chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after receiving shot lessening after about 48 hours
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| 72 | 2021-01-24 | cold sweat, pain in extremity |
leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after inj...
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leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
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| 72 | 2021-01-25 | tingling |
At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left si...
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At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left side of face; headache/Mild headache; dizzy; exhausted; GI - mild naseau; intestinal discomfort; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL32216), via an unspecified route of administration on 09Jan2021 10:00 at SINGLE DOSE at arm left for covid-19 immunisation. Medical history included known allergies: yes. Concomitant medications included levothyroxine sodium (SYNTHYROID), lisinopril, fexofenadine hydrochloride (ALLEGRA), progesterone (PROMETRIUM [PROGESTERONE]), and "PULMICO". On 09Jan2021, it was reported that At vaccine site, had numbness, tingling on lips and tongue on left side of face. This has not subsided, sometimes spreading, waxing & waning. Same day - headache, dizzy, exhausted - two days. GI - mild naseau (nausea), intestinal discomfort - on going. Mild headache continuing. The patient did not receive treatment for the events. The outcome of the events was reported as recovering.
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| 72 | 2021-01-25 | pain in extremity |
her brain is going blank; back pain that occurs in her left leg past the knee until the top of her f...
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her brain is going blank; back pain that occurs in her left leg past the knee until the top of her foot; back pain that occurs in her left leg past the knee until the top of her foot; She wanted to know if it is like a sciatic nerve pain she is experiencing; she just thought it was swelling in her spine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left shoulder on 11Jan2021 at a single dose for covid-19 immunization. Medical history included other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, spinal stenosis, has a lot of back issues, like sciatic has a lot of problems. There were no concomitant medications. The patient had the COVID-19 vaccine on Monday (11Jan2021). On Tuesday (12Jan2021), she experienced back pain that occurs in her left leg past the knee until the top of her foot. She also mentioned that she had other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, and spinal stenosis. She wanted to know if the COVID-19 vaccine can cause the adverse event that she experienced. She wanted to know if it is like a sciatic nerve pain she is experiencing. The patient stated it may sound crazy, but she got the COVID 19 vaccine on Monday, she is 72 years old, and has a lot of back issues, like sciatic has a lot of problems, and she got the shot and Tuesday) morning, her back hurt so bad, down into her sciatic, into her butt, leg, her lower leg and as far as her foot, the top of her foot, and she doesn't know if this is something that was going to happen, she read about joint pain, tiredness, that would include joints in the back, she would expect. She wonders if she is out of her head, since it was the very next morning, this was Tuesday, and instantly, she was sitting with ice and trying to get ahold of her healthcare person, she gets pain shots in her back, but she hasn't had them in a couple years, she was going along pretty good, then this was bad enough, it is in her thigh and leg, and is always under her foot, and she just thought it was swelling in her spine. She wonders if it is a side effect or her imagination. When asked for address, the patient stated her brain is going blank. She stated this may be just her. She has bad back problems, and was going along pretty good, it has been a year or two since she has had any kind of anything. But this was a good one, a strong one, the ice hurts so bad. She woke up with it, it is staying the same- after having something like this, she was trying to get ahold of the pain clinic, to get a shot, but that may be 3-4 weeks out. She has had no blood work in a while. Outcome of the events "she just thought it was swelling in her spine" and "her brain is going blank" was unknown; while not recovered for other events.
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| 72 | 2021-01-26 | tingling | PATIENT NOTED DIZZINESS AND TINGLING AND FAINTNESS MINUTES UPON RECEIVING VACCINE. |
| 72 | 2021-01-27 | pain in extremity, muscle spasms |
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he...
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1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
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| 72 | 2021-01-27 | bell's palsy, face paralysis |
DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR...
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DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR DISCOMFORT, EYE IRRITATION. CAT SCAN DONE AND ALL SHOWED OK AND THE FINAL OUTCOME ITS BELLS PALSY
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| 72 | 2021-01-27 | weakness, pain in extremity |
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished m...
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Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and sore after the first shot .today I go for the second one.
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| 72 | 2021-01-28 | weakness |
12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint ...
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12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint - felt like something was going on with my heart.
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| 72 | 2021-01-28 | tremor, numbness | Sever shakes and chilled to the bone. Fingers went numb with being so cold. |
| 72 | 2021-01-28 | pain in extremity |
awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt ...
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awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
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| 72 | 2021-01-28 | weakness |
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like he...
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pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
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| 72 | 2021-01-31 | muscle spasms | severe muscle cramps , muscle fatigue , low grade temp |
| 72 | 2021-02-01 | bell's palsy | Bell's Palsy |
| 72 | 2021-02-01 | flushing |
Complained of feeling "woozy and flushed". BP 181/97 Pulse 72 . denied history of hypertension. Re...
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Complained of feeling "woozy and flushed". BP 181/97 Pulse 72 . denied history of hypertension. Rested for 30 min. BP remained at the same level. No headache, chest pain or other complaints. Discharged home after agreeing to follow up with primary MD and /or going to ER if symptoms worsened.
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| 72 | 2021-02-01 | breast pain, pain in extremity |
her right arm began having a shooting pain that went up to her neck and left breast; her right arm b...
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her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; Indigestion; dry mouth; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982) via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 vaccination. Medical history included ongoing heart murmur. There were no concomitant medications. She received the first dose of COVID vaccine on 15Jan2021 in her left arm. Patient stated that 15 minutes after receiving COVID vaccine her right arm began having a shooting pain that went up to her neck and left breast. She was given 4 Aspirin and a Nitroglycerin tablet. She was then transported to (Institute Name Withheld) by ambulance from vaccination facility. While at the hospital blood work was obtained and her pancreas was checked. Patient stated she was there for three hours. She would like to know if she should receive the second dose of the COVID vaccine? Reported she had an adverse event 15 minutes after receiving her first dose of the COVID-19 Vaccine. She said she had pain in her right arm. She said the pain went up to her neck. She said she had pain under left breast. She said she felt like she had indigestion. She said she was told to chew 4 aspirins, clarifying she was given 4 aspirins by the ambulance staff that was at the scene to treat her. Reported she was told her blood pressure was high. She said she doesn't know what her blood pressure reading was because the ambulance staff would not tell her. Reported she noticed she had a dry mouth while she was being transported in the ambulance to the hospital. Reported she was transported by ambulance to the hospital emergency room in (City Name Withheld), (State Name Withheld). She said she was treated and released from the emergency room. Reported her neck pain was gone first, but she still felt like she had indigestion while being treated in the emergency room. Treatment: Reported the hospital staff had her drink something, and then her indigestion, and arm pain went away. She said the hospital did blood work and checked her pancreas. She said she has no information on her blood work results, saying the emergency room doctor didn't share her results with her. She said the emergency room doctor only mentioned that he was checking her pancreas. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event pain in arm was recovered in 15Jan2021, patient recovered from neck pain, breast pain, indigestion and dry mouth in Jan2021; and unknown for the other event.
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| 72 | 2021-02-01 | facial pain |
she got it Thursday and that night she noticed a little itching/itching a little again in the palm o...
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she got it Thursday and that night she noticed a little itching/itching a little again in the palm of her hands; some face soreness; her BP was 152/85 that was high; she has to got the rash on her behind where she has been scratching; having an allergic reaction; a little puffiness on her lip; the cellulitis part of her skin; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247), via an unspecified route of administration on 14-JAN-2021 at the 72 years old at single dose for COVID-19 immunization. The medical history included COPD so sometimes she would cough, kidney stent, rheumatoid ("two" Tylenol and 20 mg prednisone for "her rheumatoid"). The concomitant medication was clarithromycin (MACROBID) from an unspecified date to 12Jan2021. The patient got it on the 14Jan2021. She says she had been doing fine she didn't know now. She was a retired paramedic so she usually felt things out, she got it Thursday and that night she noticed a little itching on 14Jan2021 but she did not think anything of it. Friday evening she had a good time eating some walnuts and she woke up about 2:30 itching that was Saturday morning before day, she took Benadryl and went back to sleep later then later on she was itching a little again in the palm of her hands and she just took a Benadryl and it went away. Then Sunday night, last night, she was okay so she decided to go to the pharmacy to get some Benadryl, they had no Benadryl and she only had old Benadry. Then about 12:30 she started itching on her bottom, itching on her arms and she was scratching. She noticed she was having some face soreness in Jan2021 but she was using some expired facial cream so she thought that was why her face was sore so she put some hydrocortisone cream on it. Since she was itching she decided to take a little of her nieces Benadryl, it is pediatric Benadryl. She was itching so she called her doctor and she heard him in the ER say they had too many people in there to tell her to go to the ER so she said okay. She hung up and called the pharmacy and they said it sounds like having an allergic reaction in Jan2021 and she told him she had the COVID vaccine but she doesn't think she was short of breath and she gave them her vitals her BP was 152/85(BP 157/85) that was high for her in Jan2021, but it came down, she took some Tylenol then it was 146/77, her pulse rate was 77 and her respirations were good she did not have shortness of breath or cough well she has COPD so sometimes she would cough. Then she got up and said let me go one over and get some Benadryl so she went by there got some good Benadryl and she thought she would call and see what they think about all this. She took the Benadryl at 10:25 and she is doing okay right now but she had whelps, she has to got the rash on her behind where she has been scratching in Jan2021, it is on the left side of her hip, the cellulitis part of her skin that is mostly where she is itching in Jan2021. She remembers when she worked at the health department they would give Benadryl and Prednisone. She thought if the Benadryl does not help then she would call, then she decided she would go ahead and call to see what information they have. She says Pfizer is giving her alerts that she has been answering but she did not have the itching at that time. She retired from being a paramedic in 2009. She says she is 72 now but she woke up in 1985 and her lip was swollen like not totally swollen but her top lip was swollen more than the bottom in Jan2021. They gave her an Epinephrine shot and Benadryl and she is just wondering if this itching is related to the vaccine or if it is just an allergy that she may have come up on or something like to the walnuts or something. She says they went there and they gave the shot and they gave Benadryl but they are not sure. She said the doctor never figured our what it was that cause it and it never happened again until she did notice a little puffiness on her lip again this morning. She said the itching first started around 2:34 AM in the morning before light. It had improved since taking up to date Benadryl. She was supposed to get her second dose 04Feb2021. She didn't want COVID 19. She knew she just came off, she had a kidney stent and she had stopped taking 2 days before, she was taking Macrobid. She was not taking that right now. She took a lot of other medications but the Macrobid she was just on and it was stopped on Tuesday 12Jan2021, 2 days before the vaccine. She didn't know if the Macrobid would interfere with getting vaccine. The outcome of the event itching was recovering, the other events was unknown.
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| 72 | 2021-02-02 | pain in extremity |
1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after ...
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1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after nausea, body aches, headache, fever peak at 101.5 -treated with anti-nausea Ondansetron ODT 8mg, Tylenol 500mg -
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| 72 | 2021-02-02 | muscle twitching, feeling hot |
I woke up in the middle of night with extreme body heat and the next morning I had a beer red rash f...
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I woke up in the middle of night with extreme body heat and the next morning I had a beer red rash from my upper chest through the top of my face with itching along my jaw lines. This did not require any visit to ER although a call was made. The event lasted 24 hrs.
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| 72 | 2021-02-03 | pain in extremity | Fatigue, headache, chills, aches in extremities. |
| 72 | 2021-02-03 | burning sensation |
itching and burning sensation around the face, ears and arms and continued down the back, legs to th...
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itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3246), via an unspecified route of administration in the left arm on 20Jan2021 at 11:45 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 20Jan2021 at 23:30 (the evening after receiving the first dose), the patient experienced an itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet. The patient was treated for the events with 1 tablet of expired diphenhydramine (BENADRYL), one to one and a half hours after which the symptoms started to improve and by 02:00 the patient was able to get some sleep. Since the vaccination, the patient was not tested for COVID. The clinical outcome of "itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet" was resolved on 21Jan2021.
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| 72 | 2021-02-03 | pain in extremity |
positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt ...
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positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested in (state) and then came to (state). Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started Azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.
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| 72 | 2021-02-04 | flushing |
1333- Patient complaint of ?feeling flushed in my chest, like reflux?- vital signs 130/94, P-72, O2 ...
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1333- Patient complaint of ?feeling flushed in my chest, like reflux?- vital signs 130/94, P-72, O2 sat 99%; Patient states that she has hypertension and cardiovascular disease. States she has taken her meds today and BP?s are well controlled. Vitals taken and patient offered oral fluids. Patient observed for any additional complaints- none offered. Able to verbalize throughout assessment. By 1345 she states that she is feeling fine and episode has passed. She stated she thinks she was just very anxious. Patient instructed to seek emergency care after departure if need arises- patient verbalized understanding.
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| 72 | 2021-02-04 | feeling hot, flushing |
72 y/o Female with sudden onset of "hot" feeling with flushed feeling. No shortness of breath, wheez...
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72 y/o Female with sudden onset of "hot" feeling with flushed feeling. No shortness of breath, wheezes, stridor, nausea/vomiting, or near syncope. Pt was placed in chair and observed. Vital signs: BP 138/84, HR 72, Resp. 16, Room air O2 99%. Symptoms resolved spontaneously. Pt observed x 30 min.
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| 72 | 2021-02-04 | tremor, tingling, burning sensation |
Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling...
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Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling, and feeling shaky. Admin Benadryl 25 mg PO. Patient c/o tongue numbness. B/P 180/94. HR 70;. EMS arrived for transport but patient declined. Symptoms resolved. F/U with patient confirmed that she went to ER. Admin Decadron
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| 72 | 2021-02-04 | weakness |
Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol...
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Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol and Metamizole..
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| 72 | 2021-02-04 | tingling |
Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 6...
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Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 64; refused Benadryl.
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| 72 | 2021-02-04 | pain in extremity |
arm hurt; This is a spontaneous report from a contactable consumer, the patient. This 72-year-old fe...
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arm hurt; This is a spontaneous report from a contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899, Expiration date: 31Mar2021), first dose, via an unspecified route of administration in the left arm on 28Dec2020 at 09:30 (at 72-years-old) as a single dose for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included famotidine (FAMOTIDINE), tiotropium bromide (SPIRIVA), latanoprost (LATANOPROST), timolol (TIMOLOL) and loratadine (LORATADINE). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced arm hurt. The event did not require a visit to physician or ER. The outcome of the event arm hurt was resolved on 29Dec2020.
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| 72 | 2021-02-04 | pain in extremity |
body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a sponta...
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body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
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| 72 | 2021-02-05 | facial paralysis |
Patient experienced slight facial drooping and it went away after 2 hours. Cleared for second vaccin...
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Patient experienced slight facial drooping and it went away after 2 hours. Cleared for second vaccine by site MD
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| 72 | 2021-02-05 | slurring |
Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, foggines...
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Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, fogginess. Event lasted about one hour.
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| 72 | 2021-02-06 | tingling |
Erythematous patches on face, ears, neck, knees, dorsal aspect of ankles Tingling perioral area an...
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Erythematous patches on face, ears, neck, knees, dorsal aspect of ankles Tingling perioral area and face. No swelling, no dyspnea, no wheezing, no fever. No diaphoresis, no dizziness. Mild pruritus. Benadryl 50 mgm taken po
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| 72 | 2021-02-06 | tenderness |
Fever the evening of the shot and the next night, sore are at the site of injection for two day Lymp...
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Fever the evening of the shot and the next night, sore are at the site of injection for two day Lymph node swelling the next night after the shot in the left arm pit and has subsided as of today but still tender
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| 72 | 2021-02-07 | pain in extremity |
1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn s...
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1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn so I got out of bed, took a couple of TUMS and sat in chair , At 6 am I went to get in bed and felt nausea and started to go to the bathroom but ended up fainting. When I came to I started vomiting., Then my husband had to help me off the floor and get to the bathroom. I was vomiting and had Diarrhea. My temperature was normal. When symptoms subsided in about a half hour time I realized my right foot, leg and knee hurt. At approximately 1 pm my daughter insisted that I go to the ER, where I was treated.They ran a bunch of test but did not find anything seriously wrong with me and sent me home.
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| 72 | 2021-02-07 | muscle twitching |
14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. ...
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14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. Within a few minutes my body muscles began twitching uncontrolably. My arm,, legs,, jaw were all fluttering.. This lasted for one hour.
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| 72 | 2021-02-07 | tingling |
Approx 7 minutes after receiving the vaccine, client started c/o tingling in her left hand and the t...
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Approx 7 minutes after receiving the vaccine, client started c/o tingling in her left hand and the tip of her tongue. Vitals monitored, oxygen applied per nasal cannula. Her symptoms resolved very quickly without the use of medications. She also c/o metallic taste in her mouth. She was upset bc she had to wait 2 hours to get the shot and then had to be monitored for 1hr and 45 minutes after the vaccine. She did have one previous reaction to a pain shot in the past.
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| 72 | 2021-02-07 | numbness, migraine, pain in extremity, tingling |
I woke at 3AM Thursday morning and I had terrible pain in left arm, it down to hand and it was tingi...
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I woke at 3AM Thursday morning and I had terrible pain in left arm, it down to hand and it was tinging. I took some ibuprofen and the numbness in my hand went away and it did not help with the pain. I got about 4 AM to shower and after my husband got up. I couldn't raise my arm at all and it was hurting bad. I went the ER about 7-8AM on Thursday. I went to ER and the doctor suspected it to may be a side effect of COVID 19 vaccine. I am doing what they are saying, applying heat and taking Ibuprofen and I am trying to move it. I can lift my arm sometimes I can and sometimes I can't. The pain hasn't improved much. I can't lay on it at night because it hurts so bad. The weird thing is after I got the vaccine it hurt the first day and then it went away until the pain came back on Thursday. Monday and Tuesday before I went to ER my migraines were uncontrollable and my prescription medication was not helping, my migraine usually goes away after I take the medication. The headache was so bad I ended up taking 5 of them each day. I did not have any side effects with the first dose of the vaccine.
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| 72 | 2021-02-07 | pain in extremity |
Mild ache in thighs and joints after second shot , similar to aches after performing new exercise at...
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Mild ache in thighs and joints after second shot , similar to aches after performing new exercise at gym. No treatment. After 48 hrs, symptoms are gone.
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| 72 | 2021-02-07 | pain in extremity |
Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip f...
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Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
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| 72 | 2021-02-07 | feeling cold | Tiredness, headache,chills, fever |
| 72 | 2021-02-07 | pain in extremity |
received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up a...
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received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up around 2am Saturday 2/6 with body aches - headache -chills - took 2 more tylenol . Got up at 7am - still with same issues but with fever instead of chills and took 2 excedrin had symptoms on and off all day. On Sunday 2/7 - symptoms very mild only real discomfort was left arm still sore but ARM Pit really is sore. Took 2 excedrin and it made it mild discomfort. Only to wake up today Monday 2/8- with again really tender left arm pit & top of arm still moderately tender..
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| 72 | 2021-02-08 | facial paralysis |
Extreme headache in eye evening after, next day, and still happening. Drooping eyelid and eyeball on...
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Extreme headache in eye evening after, next day, and still happening. Drooping eyelid and eyeball on left side.
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| 72 | 2021-02-08 | tenderness |
The day of the injection my arm was mildly tender for a couple days but I did have a quarter-sized d...
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The day of the injection my arm was mildly tender for a couple days but I did have a quarter-sized dark bruise at the injection site and it had bled. About a week later the bruise started to lighten and the arm around the bruise became reddened, swollen and tender. Each day the bruise got lighter and the other symptoms were reduced. It was almost like some of the vaccine was in the bruise area and as it was released it affected the arm. It is improving on its own with no other side effects.
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| 72 | 2021-02-09 | pain in extremity |
Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm...
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Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm was sore. During the night, I couldn't get comfortable because my left arm pit started to hurt and could tell it was somewhat swollen. Woke up next morning and I had a low grade fever and my lymph nodes were tender and hurt to touch. Fever lasted all day & into the late night day after vaccine, but the arm pit lymph nodes lasted three and a half days. They are still a bit tender but not swollen today (02/10/2021). I had NO body aches but a little chills.
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| 72 | 2021-02-09 | burning sensation |
On my drive home, my face started burning. When I arrived at home the burning increased with redness...
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On my drive home, my face started burning. When I arrived at home the burning increased with redness I reported this information on Tuesday 1/26/21 to the provider of the vaccine. I was told to take Benadryl which I did immediately. On Wednesday, I continued to take Benadryl every 4 hours. On Thursday, my face continued to burn with redness and a rash. I then started to get a low grade fever and it appeared my face was swelling and then we decided to go to Urgent Care. The Doctor said my face was swollen and gave me a 1/2 dose of a steroid shot and a prescription for steroid pills. I saw my Primary Care Doctor 2/8/21 and he said I should not get the second dose of the vaccine.
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| 72 | 2021-02-09 | weakness |
Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, di...
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Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, dizziness and weakness
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| 72 | 2021-02-09 | feeling hot, flushing |
Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receivi...
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Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receiving the shot my face was very flushed and hot; lips slightly swollen; Mild itching on face continues 20 hours later; This is a spontaneous report from a contactable consumer reporting for herself. A 72-years-old non-pregnant female patient received BNT162B2 lot number unknown, via an unspecified route of administration on 22Jan2021 15:45 (at the age of 72-years-old) as a SINGLE DOSE in the right arm for covid-19 immunisation. Medical history was none. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were none. The facility where the most recent COVID-19 vaccine was administered was provided as other. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Within 20 minutes of receiving the shot, the patient's face was very flushed and hot, lips slightly swollen on 22Jan2021 16:00. Mild itching on face from unspecified date in Jan2021 continues 20 hours later. No treatment was received for the events. The clinical outcome of within 20 minute of receiving the shot my face was very flushed and hot was not recovered It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 72 | 2021-02-09 | feeling hot |
raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took m...
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raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
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| 72 | 2021-02-10 | feeling of body temperature change, tremor, seizure, weakness |
2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 a...
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2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 am bad seizure with foaming at nose and mouth, convulsions, dizzy, unable to move, terrible head pain, nausea, rapid heart beat, extreme hot and cold spells; freezing from bones out. The seizure got bettter after about an hour, but the tremors did not stop until around 6:00 am.The morning of the shot, I ate a banana for breakfast. Only thing I ate after the shot was late lunch was rice with tomatos in it, green beans, fried squash (all out of my garden).
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| 72 | 2021-02-10 | inability to speak |
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue...
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Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-02-10 | weakness |
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart ...
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Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
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| 72 | 2021-02-10 | tenderness |
Patient reports redness 3 inches long and about an inch wide on back of R side and tender in one spo...
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Patient reports redness 3 inches long and about an inch wide on back of R side and tender in one spot. Patient reports some itching that improves with ice. Patient discussed with PCP and recommended direct follow-up with a provider if the site continues to expand and/or concerns for an abscess arise.
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| 72 | 2021-02-10 | weakness |
caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he f...
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caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he felt like she was lifting weight blocks. She went to Medical Center ER and was discharged and fell and in the parking lot. Pt came back to same ER 2 days later and was admitted w/ Guillain-Barre dx. Pt was then treated with IV Immunoglobulins. Labs; Sodium 132. BUN7 , Albumin 2.7, Glucose 112, WBC 3.5 HGB 10.4
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| 72 | 2021-02-10 | cold extremities, feeling cold |
got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; ...
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got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 72 | 2021-02-14 | tingling |
20 minutes after administration, left bottom lip started to tingle and then tip of tongue began to t...
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20 minutes after administration, left bottom lip started to tingle and then tip of tongue began to tingle. Also feeling of "unwellness". These symptoms resolved in 3 1/2 hours. The next morning, felt as though I was coming down with illness. this resolved by afternoon.
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| 72 | 2021-02-14 | pain in extremity, tingling |
Most Severe: Day 3 or 52.5 hours after second dose had sever and immobilizing nausea. Could not be v...
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Most Severe: Day 3 or 52.5 hours after second dose had sever and immobilizing nausea. Could not be vertical. Vomited. This lasted 3 hrs+/-. Less severe: starting approx 9 hrs after shot I experienced intermittent tingling in right arm (had shot in left arm) as well as right bicep muscle soreness. This lasted through day 4.
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| 72 | 2021-02-16 | feeling cold, numbness, weakness |
Dizziness, spreading numbness from arm to top of head, weakness, all only on left side. Docs said th...
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Dizziness, spreading numbness from arm to top of head, weakness, all only on left side. Docs said they have seen this same reaction once before. After 45 minutes, felt able to drive but on the drive home left side of face and mouth went totally numb and swelled up., strange chemical taste in mouth. Very cold and tired. Went to bed early, slight sore throat. Numbness gradually disappeared over the following morning. Still have a sore throat.
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| 72 | 2021-02-18 | weakness |
Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness a...
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Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness and malaise, mental fogginess, chills and sweats, loss of appetite, slight nausea, needed assistance to walk. Symptoms subsided after two days, therefore did not seek medical attention.
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| 72 | 2021-02-18 | tingling |
Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 m...
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Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 min. 6 hrs later got hot spot burning under my skin in my chest, under my left arm pit to elbow and neck and lower legs. This continues when I get anxious. Like a sunburn just under the skin
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| 72 | 2021-02-20 | feeling jittery |
On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontan...
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On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontaneously resolved while staff was telling me how they would treat it. Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged. Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular. then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure. Took my blood pressure at home and it was 193/103, and I was very shaky. Went to ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs. Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL. I was discharged without medication change but had echocardiogram scheduled and follow-up appt. with Cardiologist, on zoom. He started me on Flecainide 100 mg bid, and stress test on 2/24/21 and follow-up appt. with him on 3/3/21. I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram. I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine. But my heart has remained regular since starting the Flecainide. But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.
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| 72 | 2021-02-21 | flushing |
Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction ...
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Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction to bee stings. At 10:47am patient reported feeling a flushed and reddened face, "blurry eyes", and lightheadedness. Assessment VS as follows BP 150/70 HR 70 - SR skin- warm and dry SpOx-99 % This reaction was not like a typical bee string reaction. She denies restricted airway and throat tightness. Talking in a normal rate and rhythm. Advised patient that we will call EMS for transport to a higher level of care, however patient refused. This patient was instructed to remain onsite for further observation and she agreed. She was accompanied by her spouse who was the driver. She reported that she will return home and take benadryl or the epi-pen if condition worsens. She will contact her doctor and report her experience today. Patient felt recovered and decided to leave after 30 additional minutes.
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| 72 | 2021-02-21 | numbness, tingling, tremor |
Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizzi...
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Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizziness, tremors, diaphoresis, and numbness and tingling of legs. Medical emergency team called to evaluate patient. Vital signs checked four times throughout observation period and all were within normal ranges. Patient's symptoms improved with food and juice and able to leave vaccine clinic for home asymptomatic and stable.
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| 72 | 2021-02-21 | weakness, hot flush |
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne...
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the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
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| 72 | 2021-02-21 | tingling |
tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior histo...
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tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior history of contact dermatits
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| 72 | 2021-02-22 | depressed level of consciousness |
Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consci...
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Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consciousness. The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver. Nursing staff at the nursing home reports that she seems to be a bit less responsive today. However, the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection. Of note, her oxygen saturation on room air is 72%. The patient is also febrile to 100.8°. She was unable to provide any information and the aforementioned information is gathered from nursing home staff report.
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| 72 | 2021-02-22 | tingling |
Patient at Covid vaccine drive up clinic Patient with multiple medication allergies-confirmed with ...
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Patient at Covid vaccine drive up clinic Patient with multiple medication allergies-confirmed with patient Allergies Allergen Reactions ? Levaquin [Levofloxacin] Hives ? Percocet [Oxycodone-Acetaminophen] Nausea and Vomiting ? Amoxicillin Nausea and Vomiting ? Bactrim [Sulfamethoxazole W-Trimethoprim] Other dizziness ? Hydrocodone-Acetaminophen Other ? Keflex [Cephalexin] Other Severe vertigo ? Norco [Apap-Fd&C Yellow #10 Al Lake-Hydrocodone] Nausea and Vomiting ? Oxycodone Nausea and Vomiting ? Tramadol Nausea and Vomiting patient reported tingling of face and lips after receiving vaccine @1630 States lips appeared more swollen then prior to vaccine Denies shortness of breath, wheeze, tongue/ throat swelling, chest pain, palpitation OBJECTIVE: Blood pressure :138/ 78 HR 77 Oxygen saturation 99% on room air Gen: sitting in car. No acute distress Eyes: Conjunctivae and sclera without injection/icterus and lids and lashes normal. Oropharynx moist and intact without lesions. HENT: Atraumatic. No facial droop. Minimal swelling of right upper lip without erythema. Oropharynx moist and intact without lesions. Neck: supple Pulm: No tachypnea, retractions or cyanosis. clear to auscultation bilaterally with symmetric air entry in all fields. Speaking in > 5 word sentences without difficulty. CV: regular rate and rhythm Psych: Speech fluent with normal volume, rate, and pitch alert and oriented x iii,pleasant affect/mood. Skin: Exposed areas warm,dry, without rash or jaundice ASSESSMENT/PLAN: 1. Tingling of face and lips 30 minutes after receiving Covid vaccine. No evidence of hypoxia or respiratory distress/ hemodynamic instability. Patient with history of multiple allergies to medications. Benadryl 25 mg orally x1 given @ 1640 Lot 201666 Exp 04/2023 Reassess in 15-20 minutes Addendum Reassessed at 1700 Patient reports increased swelling/tingling to lips and face right > left Denies shortness of breath, wheeze, difficulty swallowing , itching, hives Exam Gen: sitting in car- appears comfortable Eyes: Conjunctivae and sclera without injection/icterus and lids and lashes normal. HENT: Atraumatic. No facial droop -increased swelling to lips/ perioral right > left -mild erythema periorally -Oropharynx moist and intact without lesions. Neck: supple Pulm: No tachypnea, retractions or cyanosis. Speaking in > 5 word sentences without difficulty Psych: Speech fluent with normal volume, rate, and pitch alert and oriented x iii,pleasant affect/mood. Skin: Exposed areas warm,dry, without rash or jaundice ASSESSMENT/PLAN: 1. Increased edema and patient reports increased tingling of lips/ face ~ 60 minutes after receiving Covid vaccine. Not improved with benadryl 25 mg x1. Concerning for allergic reaction with history of multiple allergies. Urgent Care to continued monitoring and treatment Patient agrees Husband will transport via private care Urgent Care notified by clinic: Patient given EpiPen in case symptoms return. Instructed patient to go directly to the emergency department for any tongue swelling lip swelling trouble breathing or need to use of EpiPen. Patient is asymptomatic. Patient has additional Benadryl or will pick up from the pharmacy.
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| 72 | 2021-02-22 | numbness |
after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing fee...
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after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing feeling on right arm, fingertips numbness
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| 72 | 2021-02-22 | hot flush, discomfort |
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy...
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angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-02-23 | pain in extremity |
Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. F...
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Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. For two days
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| 72 | 2021-02-23 | pain in extremity |
My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged ly...
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My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.
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| 72 | 2021-02-23 | weakness |
Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pa...
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Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pass out." Patient had not eaten since yesterday. Given orange juice. Patient began experiencing slight altered mental status (appeared to be losing consciousness in-and-out). EMS treating patient and transported patient to ED.
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| 72 | 2021-02-23 | tingling |
Pt left tent 13 to observation lane. Pt. was complaining of tingling hands. Paramedics monitored u...
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Pt left tent 13 to observation lane. Pt. was complaining of tingling hands. Paramedics monitored until symptoms subsided. Paramedics released pt. to leave.
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| 72 | 2021-02-23 | weakness, tremor |
feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; he...
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feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient
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| 72 | 2021-02-23 | flushing | high blood pressure and flushed; 152/90 |
| 72 | 2021-02-23 | weakness |
pt states that the next day after her vax she had weakness, chills, fatigue and she still has these ...
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pt states that the next day after her vax she had weakness, chills, fatigue and she still has these symptoms. Pt states that the injection site hurt for just a few days. Pt contacted her PCP regarding her symptoms and was told not worry about them at this time but has an appt next week for an annual check up and will FU w/ her about this at that time.
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| 72 | 2021-02-24 | feeling cold |
I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a ...
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I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a fever - 99. something and aches and pains. I took ibuprofen. I got up at 7:00 am and my temperature had gone up to 100 something. My body ached really bad. It ached all day long ( and fever continued) and it felt like I had a really bad flu. I called my doctor (telemed appt) and she thought it would be over by 24 hours. It did go away after 24 hours.
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| 72 | 2021-02-24 | tenderness |
Left axillary (ipsilateral) adenopathy with tenderness. Advised symptomatic treatment due to tender...
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Left axillary (ipsilateral) adenopathy with tenderness. Advised symptomatic treatment due to tenderness (OTC acetaminophen, warm packs) and monitoring for resolution. No evidence of local or systemic infection.
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| 72 | 2021-02-24 | tingling |
Light headed and dizziness, left side headache tingling sensation down entire left arm to finger t...
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Light headed and dizziness, left side headache tingling sensation down entire left arm to finger tips, and up to chin neck and chest area for about 20 minutes
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| 72 | 2021-02-24 | numbness, facial paralysis |
Right eye will not blink closed; numbness on the right side of face, lip; and right side of mouth is...
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Right eye will not blink closed; numbness on the right side of face, lip; and right side of mouth is turned down.
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| 72 | 2021-02-25 | weakness |
None for first injection. Second injection started with extreme chills, moved to headache, muscle ac...
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None for first injection. Second injection started with extreme chills, moved to headache, muscle ache, weakness. Lasted 24 hours, mitigated with Tylenol. 10 days later, still suffering intermittent fatigue, weakness, inflamed lymph node near left breast, diarrhea and muscle ache.
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| 72 | 2021-02-25 | numbness, tingling |
Patient experienced shortness of breath and bilateral extremity numbness and tingling since receipt ...
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Patient experienced shortness of breath and bilateral extremity numbness and tingling since receipt of recent COVID vaccination.
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| 72 | 2021-02-25 | facial pain |
pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms...
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pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms, hands and knees, a splitting headache, also had pain in her ears, face, and upper back. Next day the pain was worse. Pt contacted her PCP and was told to report to VAERS. She still has pressure in her head, eye, ear ache and cant do regular every day activities.
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| 72 | 2021-02-26 | tremor |
Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and trem...
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Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and tremors. These improved 45 minutes ago. Poor PO intake. No abdominal pain. COVID, flu negative. Mild systemic vaccine reaction. Zofran given and rx. Advised patient to speak with her PCP before considering second COVID vaccine.
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| 72 | 2021-02-28 | flushing, cold sweat, tingling |
Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperaranc...
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Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperarance. States she is on beta blockers and gets light headed often. no medications given. Client recovered quickly. This information was obtained by her daughter. She denies any problems with her first dose, and only thing now is some soreness in her shoulder.
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| 72 | 2021-02-28 | weakness |
I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in gener...
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I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in general I feel like I have been poisoned.
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| 72 | 2021-02-28 | weakness | Sleepy and weakness. Drunk like sx at 1900 hr. Currently very tired. Steady gait. |
| 72 | 2021-02-28 | migraine |
Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was inje...
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Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was injected; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261; expiration date not provided), via an unspecified route of administration from 21Jan2021 to 21Jan2021 at SINGLE DOSE for an unspecified indication. Medical history included 'thyroid' from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine from an unspecified date and unknown if ongoing at 100 ug, 1x/day for 'thyroid'. Patient stated that she spoke with her physician's assistant. Patient received vaccine on the 21st of January, the first shot at her local place. The following morning at 4 in the morning, patient had severe arm pain where the shot was injected. So patient put a hot compress on it and took some paracetamol (TYLENOL). Patient mentioned that it didn't relieve for about an hour and a half. Patient meant the pain was really severe but finally it went away. The next day, it came back again and then the patient did it again and the pain keep coming back. Patient stated "And now it's been tomorrow will be a week. And that's too long to have muscle pain from my shot". Patient also mentioned that second day after the shot, migraine headache started. Patient stated, "Now I get them, but I only get them in the spring and I get them in the Fall. I don't get the migraine headaches in the winter time. I could only take Excedrin Migraine for the migraine, it's just over the counter medicine. And so I took that for the headache but those have not gone away either. When patient contacted her physician's assistant just now, it was reported that patient the physician's assistant is going to write a prescription for a muscle relaxer. Patient also reported that she is not going to take that second shot as she didn't know where to go to cancel it but she is not taking it. Patient mentioned she can't have pains like this. Patient stated that she can't tolerate pain to begin with, let alone have excess pain in her system. Patient added that she doesn't take medications. She is only on a thyroid medication (later confirmed the name as levothyroxine). Patient confirmed that the vaccine was Pfizer COVID-19 vaccine. When probed for the due date of the next shot, patient stated 'February 11th at 12 o' clock'. Patient also stated 'I am not getting it, I am not taking the second shot. I didn't get you, I don't know what you said. I am not understanding you. I am not getting what you are saying. I am not taking the second shot, it is scheduled for February 11th of 2021, I am not taking it. Because they called and asked if I wanted to receive it and my age is almost 73. So, I thought I probably should give it a chance. But now with the reaction I don't want the second one' and 'I don't know if there is something wrong with this phone or something wrong with the connection, I don't understand, I get part of it but I don't understand the other part. It blanks out, I don't know what's wrong, you are asking me something, but I don't know what it is'. Patient also reported that the pain started the day after she got the shot, 22Jan2021. Patient is still having pain. Patient also confirmed that TYLENOL was the treatment for pain but it was not working. Medication for migraine was reported as EXCEDRIN migraine. Patient further confirmed EXCEDRIN Migraine did not help with the migraine and stated 'No, I still have it, it gives me some relief but then after wears off it comes back, the migraine comes back'. Patient further added "Okay, I am just going to rely on my physician assistant, she has got some medication ordered for me, a muscle relaxer. And I am going to try that and see if that will make everything go away". Outcome of the events 'severe arm pain where the shot was injected' and 'migraine headache' was not recovered; outcome of the remaining event was unknown.
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| 72 | 2021-02-28 | pain in extremity |
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o...
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fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
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| 72 | 2021-03-01 | weakness |
Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating m...
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Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-03-01 | tremor | SOB, weakness, bilateral trembling, feeling sleepy, evaluated by EMS-cleared |
| 72 | 2021-03-02 | discomfort, pain in extremity |
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ...
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Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
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| 72 | 2021-03-02 | tingling |
In observation patient noticed a new onset of tingling and itching on her upper extremities. Admini...
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In observation patient noticed a new onset of tingling and itching on her upper extremities. Administered benadryl with no relief and subsequently given epi pen. Patient has prior allergy to flu and pneumonia vaccine. Advised by PCP to take benadryl prior to COVID vaccine which patient took. Patient presented to ED subsequent day as itching continued. No lip swelling or tongue swelling or difficulty breathing.
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| 72 | 2021-03-02 | pain in extremity |
Pain in arm; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-o...
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Pain in arm; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: 1284, expiration date was unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the hospital. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 at 16:00, the patient experienced pain in arm, which was still bad after more than 3 weeks. The patient assessed the event as non-serious. Therapeutic measures were taken as a result of pain in arm, which included paracetamol (TYLENOL) or ibuprofen (ADVIL). The patient was not recovered from the event.
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| 72 | 2021-03-02 | weakness | Throwing up, falling from weakness. |
| 72 | 2021-03-02 | pain in extremity |
abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from ...
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abdominal cramping; diarrhea; sore arm day of injection (dose 2); This is a spontaneous report from a non-contactable consumer (patient). A 72-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at arm left on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included cirrhosis unknown origin, autoimmune disease/unknown origin and no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT), omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st of BNT162B2 on 26Jan2021. The patient experienced sore arm day of injection (dose 2) on 16Feb2021, abdominal cramping/diarrhea post dose day 2 (17Feb2021) vax 2. No treatment was received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the lot/batch number has been requested.
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| 72 | 2021-03-02 | paralysis |
hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could ...
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hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
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| 72 | 2021-03-02 | pain in extremity |
while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straig...
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while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straight back, landing on the floor; her left knee keeps wanting to go out/ left leg kept wanting to buckle under her; she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm.; horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek; pain ran from the bottom of her left rib cage; caller experienced pain from her kidney to her butt cheek; her arm was mildly sore; her left leg muscle is sore from above her left knee; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00AM at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included COVID-19 in Nov2020 and lost taste and smell. Reported she tested positive for the COVID-19 Virus in Nov2020. She said she was never sick during the time she had the COVID-19 Virus, though she lost her sense of taste and smell. She said she may have had a headache during that time, but she doesn't know if the headache was from the COVID-19 Virus or something else. She said anything she was experiencing during the time she had the COVID-19 Virus was kind of normal for her. Concomitant medications were none. Reported she got her first dose of the COVID-19 Vaccine on Friday, 22Jan2021, and thinks she may be having an adverse reaction. She said after she received her COVID-19 Vaccine, she was OK for the remainder of Friday, 22Jan2021, as well as, Saturday morning, 23Jan2021. Reported she was working outside the day before she had her first COVID-19 Vaccine dose (21Jan2021). She clarified she had a tree cut down in her yard, and she moved all the 3 foot length cut-up pieces of tree by herself. She had been moving tree cuttings. Her arm was mildly sore. Reported on Saturday (23Jan2021) in the middle of supper, she experienced a horrible pain in her left back. She clarified that the pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek. She said the pain was so bad she didn't think she was going to be able to finish eating supper. She said after supper she got on a heating pad and walked around the kitchen to see if that would help with the pain. She said she sat on the heating pad and walked around the kitchen 4 times that night. She said by Sunday (24Jan2021), the pain started to go away, and by Sunday night, she was OK. Reported this past Thursday, 28Jan2021, she was going to her mailbox. She said while she was walking out to her mailbox, she was holding onto her front porch post to go down the front porch stairs, and her left leg collapsed out from under her. She said she would have fallen if she wasn't holding on to the front porch post. She said she tried to continuing walking to the mailbox, and her left knee went out from under her again. She said her left leg kept wanting to buckle under her. She said after she got back inside her house, she sat down in a chair to read a book. She said she was making soup at the time and grabbed her husband's cane to walk to the kitchen. She said she is short and got on her 2-step stool to look in the freezer for vegetables. She said while she was on the top step of the stool, her left knee buckled and her left leg went out from under her. She said she fell straight back, landing on the floor. She said she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm. She said her left leg went out from under her again, yesterday (31Jan2021), while she was going to church. She said everything she has experienced since getting her COVID-19 Vaccine shot is only happening on her left side. Reported her left knee keeps wanting to go out and she has to be really careful when she walks. She said her left knee feels like it is wanting to buckle, like when someone runs up behind you and hits the backside of your knee. She said her left leg muscle is sore from above her left knee. She said she doesn't know if what she is experiencing is from getting her first COVID-19 Vaccine dose, and she wanted to know if anyone else has reported a similar experience since receiving the COVID-19 Vaccine. For fall treatment, she took a couple of Aleve 220mg tablets (UPC Number: 325866555090, Lot Number: NAA6W3T, Expiration Date: Jun2021) on 28Jan2021, after she fell off her stool. Reported she took another 2 Aleve 200mg tablets last night (31Jan2021) at 11:00PM. Reported she is pretty darn healthy and only takes 3 pills. No other details provided. Reported she is trying to lock her left knee when she walks, saying she can feel her left knee giving away. She said she while she was walking down a small ramp at church on Sunday (31Jan2021) her left knee wanted to buckle from under her. She said she had to hold onto a railing while she was walking down the ramp, so she wouldn't fall. She said she is not used to her left knee trying to go out from under her. The reported adverse events did not require a visit to the emergency room or physician office. Outcome of events "horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek" (back pain, rib pain, and buttocks pain) was recovered on 24Jan2021. Outcome of "her left knee keeps wanting to go out/ left knee kept wanting to buckle under her" (joint instability), and "her left leg muscle is sore from above her left knee" (myalgia) was not recovered. Outcome of the remaining events was unknown.
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| 72 | 2021-03-03 | weakness |
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ...
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2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
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| 72 | 2021-03-03 | pain in extremity | Chills,fever,almost passed out,headache,sore arm |
| 72 | 2021-03-03 | pain in extremity |
Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report...
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Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
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| 72 | 2021-03-03 | pain in extremity | Left big toe swollen/painful and foot and toes were red |
| 72 | 2021-03-03 | numbness |
Numbness and slight swelling on entire left side of face within half hour following shot, accompanie...
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Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side). Headache and slight transient facial rash with skin discoloration under eyes about two hours later. Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night. Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site. Black and blue remains (3 days later).
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| 72 | 2021-03-03 | hot flush |
left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear wh...
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left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear where you cannot scratch; severe tightness in her left eye that felt like it was going to swell up; hot skin for several hours; hot flashes; She has itching in ears and throat; Onset of burning and itching; Skin had feeling of about to break out in hives/full blown body hives all over; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), intramuscular on the right arm, at the age of 72 years, on 13Jan2021 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient would like to know if the vaccine was derived from or does it have any products from Acacia. One of the reason's she was asking was because she knows it has Polyethylene Glycol in it. Her resources are limited. She was a retired healthcare provider and she taught graduate level nursing and has background in epidemiology and public health. The Polyethylene Glycol was in the vaccine, according to the prescribing information. Some forms of Polyethylene Glycol in some type of way are derived from gum acacia and she does not know if this is the case for the COVID vaccine. She did have 1st dose and waited 15 minutes. When her left eye felt tight and felt itchy, she took 2 Benadryl and then waited in car a little longer. She felt like she was going to go into what she has had in past 3-4 times relating to fish. She has had full blown facial swelling, intense itching in inner ear where you cannot scratch. Those times, if she had chopsticks, she would want to scratch inside her ear. She never had that with the COVID vaccine. They told her when she got the vaccine that if this develops further, she should go to her doctor or ER, but should not come back there. She did not want to go to the ER and sit there for 12 hours waiting to see if she was going to have a worse reaction, so she went home, took 2 more Benadryl, and went to bed. Eight hours later, she was fine and did not have hives. She then stated she completed report with Pfizer online and did not have a reference number for previous report. For those time when she had these episodes with the fish, she had extreme itching and hives. The worst allergy she had, her fingers looked like they were webbed. She was treated with Adrenaline, Cortisone and Benadryl by injection and that would usually stop the reaction, but it usually takes 3-4 days for the swelling to go down. In later years, if there is a piece of fish mixed in with fried shrimp and she inadvertently eats it, she knows it immediately. She will take Benadryl immediately. She will have facial swelling and swelling around her eyes. The Benadryl will contain it. She will be disfigured for 2 weeks, with bags of fluid in her cheeks. She is going for her second shot tomorrow. She can self treat with Benadryl. In 1994, she had a very positive wheels from an intradermal scratch testing for Acacia and codfish. The patient had an onset of burning and itching, periorbital. She took 2 25 mg Benadryl tablets. She has itching in ears and throat. After my 15 minutes waiting, she left. She had various hot spots of burning skin, legs and arms. Left eye felt like past episodes of itching, about to swell. Her skin had feeling of about to break out in hives. Facility said to go to provider or ER if got worse. She chose not to go to ER, and wait and be miserable for hours on end, while waiting for full blown body hives all over. She took two more 25 mg Benadryl and went to bed. She had intermittent burning skin, various areas, for several hours. About 8 hours later, was resolved. The patient was about to receive 2nd dose of the Covid vaccine. After the 1st dose she experienced an itchy feeling in throat, rotating heat in arms and legs, slight bag fluid under left eye and it felt to her like she was going to have an allergic reaction but did not. She took some Benadryl and after 8 hours she was fine. The patient stated after the first dose of the vaccine she had itching, severe tightness in her left eye that felt like it was going to swell up, and hot skin for several hours. She took two Benadryl while she was still in the waiting period and perhaps that blunted the reaction. She had hot flashes on the drive home. She took two more Benadryl at her daughter house (100mg total after taking 4 that day). She didn't feel good and felt she was on the verge of getting hives. She had episodes of hot skin and itching and after 8 hours it was over and done with and she was fine. She stated she is nervous about the second dose but stated they have what they need if she has an immediate reaction and it is worth the risk of getting vaccinated. Therapeutic measures were taken as a result of left eye felt tight and felt itchy/severe tightness in her left eye (eye pruritus), intense itching in inner ear where you cannot scratch (ear pruritus), onset of burning and itching (skin burning sensation), skin had feeling of about to break out in hives/full blown body hives all over (urticaria). The outcome of the event onset of burning and itching and skin had feeling of about to break out in hives/full blown body hives all over was recovered on an unspecified date while other events were unknown.
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| 72 | 2021-03-03 | muscle spasms, feeling cold, pain in extremity |
second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulde...
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second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; This is a spontaneous report from a contactable 72-year-old female consumer reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) single dose on 16Feb2021 09:00 AM at left arm for COVID-19 immunization. Medical history was not provided. Historical vaccine included 1st dose of BNT162B2 (EL3247) on 25Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Concomitant drugs included lisinopril, levothyroxine sodium (LEVOTHYROXIN), pravastatin, vitamin D and vitamin K. The patient reported second dose soreness in left arm, cold not full chills but cold, Nightime pain in right arm, shoulder neck down to wrist very sharp pains like muscle cramps started on 17Feb2021 at 01:00 AM. No treatment was received for the events. Event outcome was recovered.
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| 72 | 2021-03-04 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable Physician and a consumer. A 72-years-o...
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Bell's Palsy; This is a spontaneous report from a contactable Physician and a consumer. A 72-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Left arm on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. Concomitant medication included ASA, levothyroxine sodium (SYNTHYROID), telmisartan and simvastatin (ZOCOR). There was no other vaccine in four weeks. The patient previously took lisinopril and experienced allergy. The patient experienced bell's palsy on 20Feb2021 and treated with prednisone. Event resulted in Doctor or other healthcare professional office/clinic visit. Covid did not test post vaccination. The outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered the reported serious event as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 72 | 2021-03-04 | cold extremities, tremor |
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ...
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Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
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| 72 | 2021-03-04 | cold extremities, tremor |
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ...
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Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a little better.
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| 72 | 2021-03-04 | flushing, weakness |
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and...
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Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head, laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM, face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally 120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
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| 72 | 2021-03-04 | pain in extremity |
STARTED AT 4PM ON 3/1/2021 WITH CHILLS, GENERALIZED BODY PAIN, FATIGUE, FEVER, LEFT ARM AND AXILLARY...
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STARTED AT 4PM ON 3/1/2021 WITH CHILLS, GENERALIZED BODY PAIN, FATIGUE, FEVER, LEFT ARM AND AXILLARY PAIN WITH DECREASED RANGE OF MOTION, RIB CAGE PAIN . TOOK TYLENOL
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| 72 | 2021-03-04 | weakness |
Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hou...
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Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hours. After 4 hours weak for several hours.
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| 72 | 2021-03-05 | tremor, paralysis | Extreme shaking, leg weakness, slight fever. I couldn?t move at all. It was like I was paralyzed. |
| 72 | 2021-03-05 | numbness |
Skin red, swollen everywhere with tiny itchy hard bumps. Eyelids were red and swollen, hot and hard ...
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Skin red, swollen everywhere with tiny itchy hard bumps. Eyelids were red and swollen, hot and hard to open. Body aches and fingers partially numb.
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| 72 | 2021-03-06 | pain in extremity, muscle spasms |
Both hands & fingers swollen & VERY PAINFUL on 03-05-2021 -- cracked open more on fingers, tha...
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Both hands & fingers swollen & VERY PAINFUL on 03-05-2021 -- cracked open more on fingers, than hands- but all fingers & both hands feel like SAND PAPER--Had to use Cera/Ve Crm and wear cotton gloves to keep "moisture in"- and I have to wear gloves to wash anything by hand--Have made appt. with dermatologist for 03-11-2021 to check this condition .
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| 72 | 2021-03-07 | pain in extremity |
Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; C...
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Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Questioned if she might have a blood clot in left leg; Might have an infection in area of cellulitis in left leg; pain in the left leg; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, expiration date 31May2021), via an unspecified route of administration on 01Feb2021 at left upper arm around 19:00 or a little later at single dose (at the age of 72-years-old) for covid-19 immunization. Medical history included bad knees and got injections for this and recurrent cellulitis of legs (cellulitis was not active at time of vaccine; but anytime her leg swells with bad knees she had a little episode with the cellulitis down around her ankles on both legs but left leg was more predominant. She had been keeping it at bay), mineral supplementation, bad knee pain, blood pressure medication (abnormal), urine output control (abnormal), dehydrated and dizzy. Concomitant medication included lisinopril as blood pressure medication, potassium for Mineral supplement, solifenacin succinate for urine output control, paracetamol (TYLENOL 4) for bad knee pain. She had taken potassium before and it calmed it down: she was little dehydrated, little dizzy, so was drinking some Pedialyte, water, and taking potassium. The patient had it once before but it kind of snuck up on her again. The patient called to ask if anyone had reported any type of blood clot on the same side of the body that the Pfizer COVID-19 Vaccine was administered. She questioned if she might have a blood clot in her left leg after having been administered the Pfizer COVID-19 Vaccine. She had recurrent cellulitis in both legs prior to Pfizer COVID-19 Vaccine. The doctor thought the cellulitis in left leg may be acting up and that she might have an infection in that area of cellulitis. She reported pain in the left leg when she rested her leg on a pillow; but did not feel any pain when she was standing and walking. The pain became a little too hard for her to bear so the doctor prescribed her Cephalexin 500m capsule every 12 hours-she was on the 3rd capsule now. Onset date for the events was approximately 03Feb2021 or 04Feb2021. The events were better since started Cephalexin. Second dose date scheduled for 22Feb2021 but did not give her time. The outcome of the events was recovering. Follow-up (23Feb2021): New information received from the product quality complaint group includes confirmation of lot number (EL9262) and new expiry date.
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| 72 | 2021-03-07 | weakness |
Patient is a 72-year-old female presenting with fever and altered mental status. History is obtaine...
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Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.
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| 72 | 2021-03-08 | tremor | Complained of some SOB, light headed, shaky |
| 72 | 2021-03-08 | burning sensation, pain in extremity, numbness |
I got swollen, red, burning, painful toes, but only the big toes. Numbness in my toes and ankles....
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I got swollen, red, burning, painful toes, but only the big toes. Numbness in my toes and ankles. Is this known as Corona Toe?
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| 72 | 2021-03-08 | pain in extremity, weakness |
Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakne...
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Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakness. It lasted about 4 hours, from 9am to 1:15pm.
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| 72 | 2021-03-09 | flushing |
Four hours post injection I became flushed and broke out in hives and a red itchy rash on my body an...
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Four hours post injection I became flushed and broke out in hives and a red itchy rash on my body and legs. My heart rate jumped at the same time. I took Benadryl immediately, and for the next 24 hours. The itchy rash has persisted on and off ever since ( 6.5 weeks). In addition I have had many other symptoms. Excessive hair loss, a severe metallic taste in my mouth that is getting worse over time. At the suggestion I was scratch tested for PEG (negative), but I have since learned that test is not reliable. I tried to go on a sustained course of antihistamines but got allergic reactions to both 24 hour Allegra and 24 hour Claritin. My primary care doc has me on a course f very high dose vitamin C and I am getting some relief, but if i don't take the vitamin the itching returns.
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| 72 | 2021-03-09 | facial pain, pain in extremity |
Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down ...
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Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down my arm all the way to my fingertips. Then I started to feel disoriented. Then, as I was driving myself home, I felt constriction in my chest, like I was barely holding onto consciousness, then pain shooting up my shoulder into the left side of my neck, the left side of my face, my left eye and into the left side of my head. My heart was pounding, my head was hurting intensely and I wondered whether I was having a stroke while trapped in stop and go traffic. The intense pain continued while I drove, for about 30 minutes. Then it subsided somewhat -- but continued through the evening. I could not get to The pain continued in my arm, up the left side of my body and into my head all night. I could not sleep. My heart was pounding. Somehow I dozed off around 2 or 3am. The next day I felt groggy and tired, with the more moderate pain continuing in my arm and all the way to my hand. Finally, on Monday morning, I was able to reach my doctor's office. I was told to go the ER, which I did. They could find nothing "emergent." The pain, tiredness and headaches continued through Thursday. Friday I started to feel better -- a week after the shot on Saturday, 2/27.
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| 72 | 2021-03-09 | discomfort, night sweats |
On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labi...
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On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labile blood pressure rose; lymph nodes left neck, breast and spleen were enlarged and tender;pain/tenderness cont'd down left side lymph nodes. General ache and pressure across back (kidney area). After 2-3 days, lymph nodes on right side became tender. Labile blood pressure requires medication (generic norvasc) but still fluctuates. Pain in joints and slight "bloating" overall. Sinus mucosa completely dry (nasal). These symptoms continue as of 3/9/2021.
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| 72 | 2021-03-09 | weakness |
Temp of over 100 up to 103 Bad headache Late in second day symptoms were like MS exacerbation, weak,...
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Temp of over 100 up to 103 Bad headache Late in second day symptoms were like MS exacerbation, weak, unable to walk
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| 72 | 2021-03-09 | weakness | extreme fatigue, unable to stand alone, extreme pain in joints, weakness, nausea, glassy eyes |
| 72 | 2021-03-09 | night sweats |
in less than a minute I had a vasvagal syncope response and my blood pressure got so high that the m...
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in less than a minute I had a vasvagal syncope response and my blood pressure got so high that the machine couldn't take it--in the 200's/100 something. I was taken to the ER and monitored for a few hours and labs. BP came down slowly, but not perfect. I was released around 7pm. Event happened at 3:46pm. The next day I had chills first, then I had a slight fever, a terrible headache in the back of my head, dizziness and night sweats. By the 2nd day after I am feeling better.
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| 72 | 2021-03-10 | bell's palsy, facial paralysis |
Bell's Palsy. Right facial paralysis, right eye won't close fully. Blurry vision and teary right eye...
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Bell's Palsy. Right facial paralysis, right eye won't close fully. Blurry vision and teary right eye. Headache. Symptoms started within 36 hours. Now in day #5. No change in symptoms
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| 72 | 2021-03-10 | facial pain, unresponsive to stimuli, bell's palsy |
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no...
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Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
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| 72 | 2021-03-10 | tenderness |
Starting 24 hours after her second dose (Wed), patient experienced fever, chills, body aches, and he...
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Starting 24 hours after her second dose (Wed), patient experienced fever, chills, body aches, and headaches throughout Thursday and Friday On Saturday she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site). By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if the lump was due to the vaccine. She had a CBC taken that day that came back normal. Nothing was prescribed. Since Monday, the lump is still hard, slightly tender, and sometimes warm to the touch, but it has been getting smaller. Pt notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
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| 72 | 2021-03-10 | tenderness |
Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throug...
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Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throughout Thursday and Friday. On Saturday, she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site). By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if it was due to a vaccine. A CBC taken that day was completely normal. Nothing was prescribed. Since Monday, the lump is hard but slightly tender and sometimes warm to the touch, but it has been getting smaller. Patient notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
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| 72 | 2021-03-10 | tingling, numbness |
Within seconds of receiving the vaccine shot in my arm, I felt a feeling of a nerve sensation shooti...
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Within seconds of receiving the vaccine shot in my arm, I felt a feeling of a nerve sensation shooting across my lower face. My lower face, both sides, turned numb. I also instantly got a headache, not severe, the pain was about a 4 on a scale of 1 to 10 with 10 being the worst. After waiting 15 minutes, I asked to talk to a medical person and was directed to an EMT. I explained my facial numbness and he knew nothing about it and just said to see a doctor if it moved to any other part of my body. Over the following days, my jaw, lips and gums have been feeling a numb tingling feeling, exactly as if I have had Novocain at the dentist and it is wearing off. After one week, the symptoms were continuing and I was worried, so I called the advice nurse. After explaining my symptoms to her she advised me to immediately have someone drive me to the nearest emergency room. I went to the ER where I was seen by the dr. He did some research and said there have been a couple of other reports of people having these symptoms. He thought they would go away and wasn?t concerned. It has been 11 days now and my jaw, gums and lips still feel numb and tingly. The feeling comes and goes.
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| 72 | 2021-03-10 | tenderness, weakness |
slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able...
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slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able to lay on it or rub it
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| 72 | 2021-03-11 | numbness, cold extremities, tremor |
3 days after receiving my 1st dose of the Pfizer Covid vaccine, I woke up with a numb, cold, weak l...
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3 days after receiving my 1st dose of the Pfizer Covid vaccine, I woke up with a numb, cold, weak left arm. No soreness in that arm prior to this event. I had a fine tremor on extension of my left arm. Symptoms resolved after 45 minutes , but returned within a half hour and repeated. I called my doctor and spoke to the advice nurse. I was adviced to go to the ER within one hour. Instead a did some deep breathing and relaxation and my symptoms resolved and have not returned. I spoke to a doctor and agreed to go to the ER if they returned and also discussed the symptoms with my primary doctor during a video visit and she adviced daily baby ASA.
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| 72 | 2021-03-11 | muscle spasms |
Around 11:00 a.m. the day following receipt of the 2nd dose vaccine, I experienced horrible body ach...
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Around 11:00 a.m. the day following receipt of the 2nd dose vaccine, I experienced horrible body aches and fatigue. I went to bed but couldn't get any sleep because of muscle cramps and charley horses. Around 4:00 p.m. I experienced chills and had to wrap myself in a blanket over my clothes. At that point I took my temperature and it was 100.4. I took it again a few minutes later and it was 99.4. I went back to bed and slept until 3:00 a.m. when I woke up to get some water. I got up today at 7:30 a.m. and all symptoms were gone.
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| 72 | 2021-03-12 | pain in extremity |
I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner...
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I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner and until about 9 hours after the injection when my arm felt exceedingly sore. I had been watching a free Amazon Prime cute movie while knitting a blanket for my grandson. When the movie was over and I was clearing my knitting, I noticed my super sore arm. I got up to check my face in the mirror to be sure that I was not having a reaction. But I did have a reaction with a rash on my chest and face 9 hours after the injection. My arm really hurt for three days but is fine now. When I saw my red face and chest, I took a Zyrtex D and a Benadryl. It did not seem to help the redness to go away. When I felt some tightening of my throat and started to feel that I might be starting to lose some clarity of thought, I quickly watched a minute video on how to use my new kind of generic epipen and jabbed myself in the leg and called 911. I felt much better after the epipen in terms of my thinking and throat. Basically, the medics that came to the house and said that I had taken what they would give me at the hospital and it was up to me if I wanted to go to the emergency room or not; they would take me but I would need a ride home. With the pandemic and 48 new cases, I decided to stay home and I went to bed; the rash on my face was gone in the morning. The next days I just felt muscle soreness all through my body (day 2) and felt tired (next two days) but had no fever at any time. I am fine today. I appear to have two very small areas on my chest that probably related to the reaction.
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| 72 | 2021-03-12 | discomfort, muscle twitching |
The left side of my mouth started visibly twitching and I was concerned I might be starting Bell's P...
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The left side of my mouth started visibly twitching and I was concerned I might be starting Bell's Palsy or something similar. I had my husband look at it and he thought the same thing. We researched the Pfizer Vaccine and discovered there were rare instances of Bell's Palsy during the trials for the vaccine. We also found that tics of this nature are more common. We waited a while and the symptom subsided and I went to bed. When I woke up in the morning the twitching did not recur, but there is a heavy sort of feeling on the left side of my mouth.
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| 72 | 2021-03-12 | pain in extremity, weakness |
There were two adverse events, loss of muscle strength in abdomen, such that rising from a sitting t...
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There were two adverse events, loss of muscle strength in abdomen, such that rising from a sitting to a standing position and then marshaling the muscles to walk was extremely difficult and I could not fully straighten my back once on my feet. This began on March 6 and lasted three days. The second was the development of a lump in the underside of my right metatarsal arch, which remains there. It is painful to the touch. I noticed it on March 8 or 9.
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| 72 | 2021-03-12 | feeling cold, discomfort |
Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills....
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Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills. Felt very tired. Headache. Nurse checked oxygen level within 10 minutes and it was well above normal. Nurse put me in recliner and I slowly calmed down and felt sleepy. Left in one hour walking to car and driving home. These symptoms lasted 7 days. Very irritated for 7 days. Very uncomfortable.
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| 72 | 2021-03-13 | pain in extremity |
After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of...
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After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of upper thighs. After second shot, severe headache. I couldn't stand light for first 24 hours then continuing headache for 4 days. First 24 hours, pain in arms to fingers, neck, upperback, ache all over. Second and third day nausea.
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| 72 | 2021-03-13 | numbness |
Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to t...
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Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to the ED>
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| 72 | 2021-03-13 | pain in extremity |
Dose 2 Pfizer @ 10:30 AM Thursday, March 11. Event: Friday, March 12, 6:00 AM excruciating total le...
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Dose 2 Pfizer @ 10:30 AM Thursday, March 11. Event: Friday, March 12, 6:00 AM excruciating total left leg shooting pain with no relief or ability to ambulate. Saturday, March 13; friend took me to the Hospital ER upon my request. The non- stop pain was intolerable! I wanted X-Rays because I thought something somehow was broken. There was no fall or any accident of any kind. The X-Rays revealed strong arthritis & sent me home w crutches & an Ace bandage wrap. Recommended ice &/or heat, otc Tylenol or naproxen, which I did all day. Sunday, March 14, I was 80% improved. I attribute this strong reaction as triggered out of the blue by the 2nd Pfizer dose!
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| 72 | 2021-03-13 | burning sensation |
On day 12 after first dose itching began. On day 13 a raised, red 2.5-inch circle around the inject...
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On day 12 after first dose itching began. On day 13 a raised, red 2.5-inch circle around the injection site appeared and the itching became severe. Hydrocortisone Ointment (2.5%) was applied, but afforded little relief. The rash and itching continued for about three weeks, only lessening the last several days. Also on day 12 after the first dose, my lower lip began to feel as if it were sunburned (which it was not) and swelled slightly. Lip balm was applied. The strong burning feeling lasted burning lasted for about three weeks, only lessening the last several days. On the day following the second dose, a smaller red circle appeared around the injection site which itched moderately. It did not continue to itch or appear red after 3 days post injection.
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| 72 | 2021-03-14 | muscle spasms |
Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe j...
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Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe joint pain, sensation of swelling in L axilla although no actual swelling noted, pain at injection site, leg cramping, mouth pain (gums & teeth)
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| 72 | 2021-03-14 | weakness | Headache, stiff neck, weak body, fuzzy thinking, shaky, unstable walking, metal taste in mouth. |
| 72 | 2021-03-14 | weakness, muscle spasms, pain in extremity |
I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even dri...
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I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even drink a sip of water. cramps. leg pain. pain inbetween my shoulders. I could barely stand up, I was very weak. I went to the hospital and got a few shots to help with the vomiting. (Finigan) and medicine for the cramps and muscle aches. Fatigue and headache still lingers.
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| 72 | 2021-03-14 | pain in extremity, flushing |
I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within fiv...
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I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within five minutes, my face became flushed, a little puffy, and very hot. I put cold compresses on it for about 10 minutes. When it was less red, I left to return to home. I had no fever. I had only a sore arm and extremely tired for 36 hours. No breathing difficulties -- during the flush or afterwards.
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| 72 | 2021-03-14 | feeling jittery, feeling hot |
Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if...
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Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if stomach.
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| 72 | 2021-03-14 | burning sensation |
burning sensation in lower back and both legs, dizziness, head fog, fatigue all lasted 24 hrs Have...
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burning sensation in lower back and both legs, dizziness, head fog, fatigue all lasted 24 hrs Have developed tinnitus with high pitch noise which seems to be in both ears.
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| 72 | 2021-03-14 | weakness | night chills, sweating, dry heaves, weakness, tiredeness |
| 72 | 2021-03-14 | weakness, speech disorder, tremor, pain in extremity, tingling |
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur...
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severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
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| 72 | 2021-03-15 | tenderness, numbness, tingling |
I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv...
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I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
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| 72 | 2021-03-15 | pain in extremity, cold extremities |
On March 12, I experienced some pain in left hand. By the next day, my hand was somewhat swollen, s...
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On March 12, I experienced some pain in left hand. By the next day, my hand was somewhat swollen, stiff and I had trouble grasping items. The pain was worse on March 14, to the point that I could barely move my hand. My arm from below my elbow was also sore. I took Tylenol and, later, aspirin. My hand was swollen and the veins appeared dark through the skin. My hand felt cold and applying warm compresses helped ease the. pain. By March 15, the pain started to go away and by March 16, my hand and arm were back to normal.
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| 72 | 2021-03-15 | muscle spasms, weakness |
Patient received 1st Pfizer Covid-19 Vaccine on 03/06/2021 - since receiving the vaccine patient has...
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Patient received 1st Pfizer Covid-19 Vaccine on 03/06/2021 - since receiving the vaccine patient has generalized weakness - muscles spasms and Myalgia that has not subsided since vaccine
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| 72 | 2021-03-15 | facial paralysis |
Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and C...
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Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and CT of head all negative. Kept overnight and had MRI 3/9/2021 in AM revealed "mini stroke" TIA per neurology. She was discharged with Plavix and Lipitor. Has follow up appointment with neurologist 4/8/2021 and cardiologist 4/1/2021. Patient states she was on Amiodarone and Bystolic prior to having this TIA. Patient is scheduled for second dose of vaccine 3/19/2021 and wants to receive it. She is cleared to receive from our stand point. Please reach out via email or phone if you guys disagree.
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| 72 | 2021-03-15 | burning sensation, weakness |
Severe rash started on my hips and became beet red, burning and itching intensely. Over the next 2 ...
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Severe rash started on my hips and became beet red, burning and itching intensely. Over the next 2 days the rash spread up my back, and to the top of my thighs. The second day it spread down my legs to my feet (but not as severe) and on my arms down to my hands. My head also began itching. This lasted for about 10 days and has now cleared up. I experienced extreme exhaustion and dry mouth. I still feel tired and have a dry mouth when arising.
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| 72 | 2021-03-15 | tenderness |
The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomf...
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The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomfortable, with slight redness to area. Over course of next 5 days I felt more tired than usual as swelling subsided. After first vaccine I only experienced left arm soreness at injection site, mild headache and some tiredness for first 24-36 hrs.
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| 72 | 2021-03-15 | flushing | flushing of skin, throat swelling, SOB |
| 72 | 2021-03-16 | pain in extremity | Pain in calf of left leg. Two blood clots lower left leg, being treated with blood thinner Xeralta |
| 72 | 2021-03-17 | tingling |
Itching all over body, Foggy, eyes rollingback in head, unable to articulate information, fingers...
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Itching all over body, Foggy, eyes rollingback in head, unable to articulate information, fingers tingling.
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| 72 | 2021-03-17 | feeling hot |
Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, ch...
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Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, chills, nausea, feeling unwell, feeling hot (but no actual temperature). I did NOT have a severe allergic reaction, just
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| 72 | 2021-03-17 | flushing |
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lighthead...
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
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| 72 | 2021-03-17 | discomfort, pain in extremity |
The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea...
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The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea. These went on for the next week. I didn't go into work February 26th. But did go in partial days all the next week. Very uncomfortable. The headache got worse each day until it was very bad. On March 10th I woke up with my left arm in excruciating pain and the headache. Went to urgent care and doctor gave me a shot of Tromodol. When I got to the parking lot, I became very dizzy and my legs gave out and fell in the parking lot down to t he ground. Went to ER and waited for about 3.5 hours and left and went home. Went back to ER on March 12th due to arm in constant pain. Not able to sleep or relax. Wait this time was 3 hours and I was in too much paid so my daughter took me around the corner to urgent care. I was given steroid, muscle relaxer and a cream for my arm. My left arm from muscle up to shoulder and into wrist continues to hut. Today is 3/18/2021.
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| 72 | 2021-03-18 | tremor |
Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile...
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Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile walk Monday pm, missed meeting. Took 2 Tylenol, slept. Tues-Thurs: fatigue, chills, aches, diminished over the days. I rested and slept. Today=Friday, declared myself cured, took shorter walk, got tired, normally don?t get tired. *Today I discovered why I felt crooked: right shoulder higher because it?s swollen, down to mid-way between elbow & wrist, down to waist, some of side of body.* Treatment still only rest, but still I'm not so fatigued, aching easy to ignore. Never had fever (temp around 96.8 which is normal for me). I never felt too bad. Except for overpowering fatigue, I felt like doing things.
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| 72 | 2021-03-18 | weakness |
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tastel...
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RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
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| 72 | 2021-03-18 | pain in extremity |
sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24h...
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sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24hr
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| 72 | 2021-03-19 | pain in extremity, weakness, speech disorder |
Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, w...
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Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, weakness, stumbling, few words not coming out quite correctly. These challenges seem to be improving. Tiredness, headache, unwell feeling, arm pain, fever.
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| 72 | 2021-03-19 | feeling hot |
Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 11...
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Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 110.
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| 72 | 2021-03-20 | pain in extremity |
Painful and swollen left knee; Painful and swollen left knee; Painful and swollen thigh after 24 hou...
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Painful and swollen left knee; Painful and swollen left knee; Painful and swollen thigh after 24 hours after vaccination.; In left arm pain; little swollen in 5 hours after; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Feb2021, the patient experienced in left arm pain, little swollen in 5 hours after, On 13Feb2021, the patient experienced painful and swollen left knee, painful and swollen thigh after 24 hours after vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of in left arm pain (pain in extremity), little swollen in 5 hours after (peripheral swelling), painful and swollen left knee (arthralgia), painful and swollen left knee (joint swelling), painful and swollen thigh after 24 hours after vaccination. (pain in extremity). The outcome of the event was not recovered.
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| 72 | 2021-03-20 | seizure |
Patient had one of her typical seizures on 3/14/21. She did not seek care. She managed at home and c...
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Patient had one of her typical seizures on 3/14/21. She did not seek care. She managed at home and called 2 days later to notify my office that the seizure had taken place . She was feeling well.
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| 72 | 2021-03-21 | pain in extremity |
I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudde...
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I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudden bout of plantar facsitis, then increase in other arthritis symptoms. Then a week after I suffered a stomach virus. Then latter that same week for two days I experienced severe right leg pain. Then developed cluster rashes on the whole right leg. Went to Urgent care since we are wintering out of state. Was diagnosed with Shingles which I have never had and hope to never have again. The blisters are improving but the pain remains. I very strongly feel this is ALL due to the second dose of this vaccine. I certainly feel the second dose of this vaccine should not be given for at least 6 months.
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| 72 | 2021-03-21 | pain in extremity |
I received the Moderna COVID shot for my 1st injection. Now I received the Pfizer COVID shot for my ...
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I received the Moderna COVID shot for my 1st injection. Now I received the Pfizer COVID shot for my 2nd injection. Two days after my 2nd injection I have developed swelling and redness and painful reaction in my left arm. Left arm is also very warm to the touch. The CDC website says Moderna should be used for 2nd injection if used for 1st injection.
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| 72 | 2021-03-21 | weakness | Severe headache, nausea, vomiting, muscle and joint pain, weakness, fatigue and chills |
| 72 | 2021-03-21 | weakness |
altered mental status, weakness, presyncopal. Evaluated by EMS-Transported to Emergency room/departm...
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altered mental status, weakness, presyncopal. Evaluated by EMS-Transported to Emergency room/department or urgent care.
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| 72 | 2021-03-22 | numbness, burning sensation, discomfort |
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose star...
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Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
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| 72 | 2021-03-22 | tremor |
Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness a...
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Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
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| 72 | 2021-03-22 | burning sensation |
Swelling, itching, burning, redness, blocked ears (I needed to hold my nose and blow) itching - most...
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Swelling, itching, burning, redness, blocked ears (I needed to hold my nose and blow) itching - mostly hands, face, torso. Redness - hands, arms, torso, crotch. Called primary MD, called Healthcare facility clinic, went to pharmacy and spoke to pharmacist. Took Benadryl.
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| 72 | 2021-03-22 | weakness | Weakness, body ache, fatigue |
| 72 | 2021-03-23 | flushing |
my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started ...
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my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 72 | 2021-03-24 | bell's palsy |
73 year old female client told RN on 3/22 that on March 14th, after getting 2nd dose of Pfizer vacci...
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73 year old female client told RN on 3/22 that on March 14th, after getting 2nd dose of Pfizer vaccine (EN 16203). On March 15th morning, she got Bell's Palsy on her R face. Her doctor sent her to ER and the doctor prescribed her Prednisone (20 mg tid) and Valacyclovir (1 g tid) for 7 days. After one week, client was slowly recovered.
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| 72 | 2021-03-24 | pain in extremity |
A pain which hampers my ability to lift my arm, i always feel the injection site . No ice or heat r...
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A pain which hampers my ability to lift my arm, i always feel the injection site . No ice or heat relives pain. Any kind of lifting causes pain and just plain use of that arm feels like there is a swelling inside my arm. Shot # 2 not any problems at all.
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| 72 | 2021-03-24 | one side paralysis, inability to speak | Aphasia & right sided weakness. CVA. |
| 72 | 2021-03-24 | migraine |
two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is ...
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two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included warfarin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 10:00, the patient experienced two migraine headaches and atrial fibrillation. It was unknown if the patient received any treatment for the events. The clinical outcomes of the two migraine headaches and atrial fibrillation were recovered in Mar2021.
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| 72 | 2021-03-25 | flushing |
"Pfizer-BioNT Covid-19Vaccine EUA" Because I am allergic to Hornet sings I waited 30 mins after the ...
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"Pfizer-BioNT Covid-19Vaccine EUA" Because I am allergic to Hornet sings I waited 30 mins after the injection. I was fine so I walked out to my truck. I became flushed in the face and my mouth had a metallic taste so I walked back into the clinic to tell them. They took my Blood pressure which was 200/125. I felt very off so they wheeled me into Urgent Care where they gave me one benadryl and monitored my blood pressure. They then called for ambulance for ER . I was released when my blood pressure was lower. I will not get the second injection of Pfizer!
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| 72 | 2021-03-25 | migraine |
After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later...
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After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later, had 11 out of 12 days of migraine and after 8.5 days after shot had a whole body rash for 4.5 days . I have had vertigo most every day since the last shot on 2/20 and have had 27 migraines since the 1st shot Jan 30th I used Hydrocortisone on the itchy, blistery rash. Not much sleep for 3 nights. The night before the rash popped out I experienced chest pain that I thought was heartburn but was not relieved with baking soda and water and charcoal pills. It didn't go away until the hours into the next day and the rash was there at 3am. I have had Migraines for many years but this is 4 times more migraines.
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| 72 | 2021-03-26 | feeling cold, feeling of body temperature change |
Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both a...
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Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both arms. At 11 pm went to bed with large lump in my throat, felt like I was breathing thru a straw plus whole body freezing from inside out. Could not get warm. Added layers of clothes and blankets and laid like that all nite, no sleep. 7am called nurse, advised to remove some of the layers, drink hot liquids and Tylenol every four hours. By mid afternoon the cold was gone but severe achy bones, even the bottom of my feet hurt. Next day hot and cold and ache. Fourth day dripping sweat all day and flu like symptoms. Took three showers to get sweats down plus the entire time had been taking Tylenol every four hours. Day five just drained, felt like I'd been through the wringer.
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| 72 | 2021-03-27 | bell's palsy |
Bell's Palsy - right side of face is paralyzed, right eye doesn't close fully, teary right eye, blur...
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Bell's Palsy - right side of face is paralyzed, right eye doesn't close fully, teary right eye, blurry right eye, and headache; This is a spontaneous report from a contactable healthcare professional (patient). A 72-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in right arm on 05Mar2021 10:00 as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hypothyroid, chronic achilles tendonitis, pre-diabetic. The patient had no known allergies. Concomitant medications included losartan, metoprolol; thyroid (NATURE THROID) reported as 'Zinc Berberine Nature Throid.' The patient was not diagnosed with COVID prior to vaccination. She was not pregnant. No other vaccine was administered in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via unspecified route in right arm on an unspecified date at 12:00PM. On 06Mar2021 12:00PM, the patient experienced Bell's palsy - right side of face was paralyzed, right eye doesn't close fully, teary right eye, blurry right eye, and headache. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received included CT scan of brain, prednisone 60 mg total, and valaciclovir (VALTREX) 1. Outcome of the events was not recovered. The patient had not been covid tested post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-03-28 | hot flush | Racing Heart/patient felt flush |
| 72 | 2021-03-29 | numbness, seizure, tremor, cold extremities |
mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left a...
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mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left arm was weak, numb, cold; left arm was weak, numb, cold; a fine tremor on extension of my arm; This is a spontaneous report from a contactable other hcp (nurse and patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:45 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 72 years) for covid-19 immunisation. Medical history included partial seizures, autoimmune thyroiditis, eczema, osteoarthritis, asthma, irritable bowel syndrome, carpal tunnel syndrome from an unknown date and unknown if ongoing 10 years ago. The patient is not pregnant, and the patient did not have Covid prior vaccination. Concomitant medication included phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; levothyroxine sodium (SYNTHROID); ergocalciferol (VIT D) and unspecified vitamin. The patient previously took amoxicillin and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, azithromycin and experienced drug hypersensitivity. The patient experienced mini stroke or seizure on an unspecified date with outcome of unknown, left arm was weak, numb, cold and a fine tremor on extension of arm on 03Mar2021 14:45 with outcome of recovered. On 06Mar2021, patient woke up and left arm was weak, numb, cold and she had a fine tremor on extension of arm. Symptoms resolved after 45 minutes but returned within 30 minutes and lasted another 45 minutes. No treatment was received for left arm was weak, numb, cold and she had a fine tremor on extension of arm. Patient called doctor, spoke to the advice nurse and was advised to go to the ER (emergency room) now. Patient did deep breathing and relaxation, symptoms resolved, and did not go to the ER. Instead spoke with a doctor and agreed to go to the ER if symptoms returned. Patient also had a video visit with primary doctor, and she was advised to take baby ASA. The Doctor said it could be a pinched nerve on unspecified date with outcome of unknown. Symptoms have not returned. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021. The case was reported as non-serious.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the CVA and other events. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, EEG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 72 | 2021-03-30 | pain in extremity |
body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous repor...
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body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous report from a contactable consumer(Patient). A 72-years-old female patient received bnt162b2 (Pfizer- BioNTech Covid 19 Vaccine, Lot Number: EL3248 ), dose 1st via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure , overweight and covid-19 (if covid prior vaccination: Yes). Concomitant medications included Losartan 100 mg, rosuvastatin 10mg, vita C 1000mg. The patient previously took statins and experienced drug hypersensitivity. Patient experience body aches, headache, both arms sore, left arm pit sore, on and off chills and fever all were on 06Feb2021 02:15. Treatment was not received for the adverse event. Patient was not pregnant. The outcome of the recovering.
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| 72 | 2021-03-30 | difficulty speaking, facial pain |
had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylacti...
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had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; pain in abdomen and face/Abdominal pain; pain in abdomen and face; Generalized pruritus with skin rash; Respiratory distress; Angioedema (not hereditary); a lot of pain after her tooth extraction; Upper airway swelling; Cyanosis; Hoarse voice; Difficulty breathing; Sensation of throat closure; Generalized urticaria (hives); Generalized erythema; Generalized pruritus with skin rash; Localized injection site urticaria; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6199) (at the age of 72 years old) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD); osteoarthritis; rheumatoid arthritis (RA); allergy: Environmental; asthma. Concomitant medications included ubidecarenone (COQ10 [UBIDECARENONE]) ongoing; atorvastatin ongoing; nebivolol hydrochloride (BYSTOLIC) ongoing; methimazole ongoing. The patient was taking some medications prior to the event being reported. No prior vaccinations (within 4 weeks). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than bnt162b2 prior to the event being reported. The patient had not received any other vaccines around the time of bnt162b2 vaccination. Caller would like to know if there was an impact on efficacy if she chooses to take her second dose of the Pfizer BioNTech COVID-19 vaccine at a later date than the recommended 21 days. Caller received her first dose of the Pfizer BioNTech COVID-19 vaccine on 03Mar2021. She stated that on 08Mar2021 she had a tooth extraction and was told by her physician to take Advil. Then on 11Mar2021 caller reported that she had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days. She stated that her physicians were unsure if it could have been a delayed reaction to the vaccine or a reaction to the Advil (which caller stated she had taken all her life) (lot number: 55633, Expiry Date: Feb2023). Caller was scheduled to receive her second dose of the vaccine next week and would like to know if she should take it. She stated one physician told her it was okay to do so while another told her to hold on taking it, so she was confused as to what to do. Reporter seriousness for Anaphylactic reaction was Hospitalization. The patient was in hospital for Anaphylactic reaction from 11Mar2021 to 14Mar2021. The patient stated she received her first COVID vaccine on 03Mar2021, and on 08Mar2021, she had a tooth extracted. Because of that, she was taking Advil on 11Mar2021, she had an anaphylactic reaction to the Advil and an acute hepatitis. And the doctors couldn't give her any answer. They didn't know what caused what and if it was a delayed reaction from the vaccine because it was one week following the vaccine or if it was just coincidental. The patient due next week (scheduled for 23Mar2021) for her second dose and wanted to know if she should she take it. She ended up in the hospital for five days. Date of hospitalization was 11Mar2021. Reason for hospitalization was Anaphylactic reaction. Date of discharge from the hospital was 14Mar2021 (pending clarification). Event "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days" started from 11Mar2021 18:00. Seriousness Criteria: Hospitalization / Prolongation of hospital, hospitalized Duration of stay was 5d, event not recovered. The event required visit to Emergency Room. Treatment included steroids and fluids IV. "Tooth extraction" started from 08Mar2021 and treatment included Tylenol and Advil. Consumer stated she was still in a lot of pain after her tooth extraction (Mar2021). On 08Mar2021 she had a tooth extraction. After the procedure she had severe pain and she was taking Advil and by Thursday 11Mar2021 she had a lot of pain in abdomen and face. She went to ER 18:00 PM, she was going through a complete reaction. The patient required medical intervention: Corticosteroids, IV fluids. The patient was seen in the Emergency Department. The patient had hospitalized for 5 days. The patient was not admitted to an Intensive Care Unit. In Mar2021, the patient had Upper airway swelling, Respiratory distress, Cyanosis, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Generalized urticaria (hives), Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Localized injection site urticaria, Abdominal pain. No Bilateral wheeze/bronchospasm. No Stridor, No Increased use of accessory respiratory muscles, No Recession, no Grunting, no Dry cough, no Sneezing, No Rhinorrhea, No Shock, No Tachycardia, No Capillary refill time > 3 sec, No Decreased level of consciousness, No Loss of consciousness, No Generalized pruritus without skin rash, no Generalized prickle sensation, No Diarrhea, no Nausea, no Vomiting. Tachypnoea: Unknown. Measured hypotension: Unknown. Reduced central pulse volume: Unknown. The events did not require the initiation of new medication or other treatment or procedure. Lab work included Liver function over 10 000 in Mar2021. Patient's outcome following the potential anaphylactic reaction was Recovering. The outcome of the events "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days", "a lot of pain after her tooth extraction" was not recovered, of "pain in abdomen and face" was unknown, of the other events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events anaphylactic reaction, hepatitis acute, and respiratory distress with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-03-30 | feeling cold |
her skin hurts all over; she was cold during the night; hurts to be touched and pull on pants; This ...
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her skin hurts all over; she was cold during the night; hurts to be touched and pull on pants; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. The patient's concomitant medications were not reported. On an unspecified date, the patient reported, her side effect stating her skin hurts all over, she was cold during the night, hurts to be touched and pull on pants. The seriousness was reported as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-04-01 | cold extremities |
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hos...
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Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs. Patient was treated and discharged home.
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| 72 | 2021-04-04 | inability to speak |
Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion,...
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Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home
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| 72 | 2021-04-06 | facial paralysis |
1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommen...
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1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommended calling EMT. EMT said no stroke but could go to urgent care for further evaluation. Urgent care recomended ER. ER recommended appointment with Neurology 2nd symptom 3/21/21 slight droop on right side of mouth. Went to ER in Hospital. MRI revealed clot. Additional ultra sound of heart and carotid arteries clear. Final diagnosis: Subacute CVA-Lt Centrum Semiovale w/ right facial droop and right hand deficits. Recomendations: Nuerology evaluation, Outpatient PT/OT for right hamd deficits. Hospitilization: 1 day Hospital Name: Unnamed City: Unnamed State: Unnamed
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| 72 | 2021-04-11 | weakness |
Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/1...
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Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/11/2021 with fatigue, cough, hypokalemia, and generalized weakness. She was admitted to an inpatient unit and tested for COVID-19 which came back positive. Anticipated discharge is today, 4/12/2021
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| 72 | 2021-04-17 | pain in extremity |
congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; a...
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congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for herself. This is report 1 of 2. A 72-year-old consumer (female) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiry date: May2021) via an unspecified route of administration on 25-FEB-2021 at left arm around 11:30 -12:30 and patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730/GR8730) via an unspecified route of administration on 25Mar2021 both as a single dose for COVID-19 immunization. Medical history and concomitant medication reported as diabetes and blood pressure medicine (From: Unspecified To: Ongoing), has since about 2015 or 2013 or something like that. She declines to provide her medication. She is not a serious diabetic. Sometimes she does not have to even take the diabetes medication because she keeps her A1C is so low she doesn't have to take the diabetes shots. She did not receive any other vaccines within four weeks prior to the vaccination. She didn't have any other real problems with the first dose of Pfizer COVID-19 Vaccine other than her arm getting sore. For her second Pfizer COVID-19 Vaccine she don't have to bother her arm. She had a little cough started sometime last week before she took the second Pfizer COVID-19 Vaccine. The cough doesn't happen all the time. She was coughing quite regular every 2-3 minutes before. She got the Diabetic Tussin cough syrup which has no sugar or alcohol. After taking that cough started quieting down. She was asking is it a regular cough or did the Pfizer COVID-19 Vaccine cause the cough. She's taking it once a day sometimes twice a day. It is nasty cause it's got nothing in it. Maybe she is not taking it enough, it says to take it every 4 hours, maybe she is not taking it enough, she does not know. She is taking it maybe once or twice daily, maybe she takes it more. She reports it's not a constant cough. She also has some congestion in her chest. The congestion in her chest it's tight, she just knows it's there. Her chest congestion is staying about the same. If she gets rid of the cough, she'll get rid of the chest congestion she guesses. Caller reported that people are not educating themselves on these shots, referring to the Pfizer COVID-19 Vaccine shots. They'll tell you it's gone kill you; that she does not believe because some people have died, they took the shot and they didn't get a chance to take the second shot and they passed away. And they are telling her not to get the vaccine because it's going to hurt her. She's going to put it in God's hands and take that Pfizer COVID-19 Vaccine to help prevent or at least have it in her system. She's 72 years old and concerned about herself. The outcome of the event arm sore is unknown, little cough with outcome recovering, congestion in her chest outcome not recovered. Follow up (29Mar2021): This is a Follow-up spontaneous report received from a contactable consumer reporting patient information, event information, concomitant medication. Follow-up attempts are needed. Information on lot/batch number was obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347466 Pfizer
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| 72 | 2021-04-17 | pain in extremity |
hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/cli...
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hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195; Drenched in sweat/sweating/sweating like a dog in the middle of the night; Wasn't feeling well; Tightness in chest; Cough; Sinuses congested; Sore; Puffy, bubbled up arms, inflamed; Puffy, bubbled up arms, inflamed; Feverish/felt hotter than usual; Really, really tired/wiped out tired; so sleepy; Sore Arm/her arm started to hurt; Nauseous; Sore Throat/throat hurts; eyes half closed/eyes closing; Puffy Face; blood clot; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733, expiry date: unknown), via an unspecified route of administration, on 29Mar2021 11:45, as single dose, for COVID-19 immunisation. Medical history included ongoing latex allergy (developed welts where the straps met the skin) diagnosed 20-30 years ago; ongoing dye allergy (developed warm soreness to leg, tightness in the chest, could not breathe) diagnosed many years ago; sulphite allergy (diagnosed about 1975-1980; cannot eat processed foods, bleached foods, frozen pre-made foods; tries to eat only single item foods; last anaphylactic reaction after eating olive oil at a restaurant because it had sulphites in it; Mother was possibly allergic to sulphites; Son also allergic to sulphites); and blood pressure that runs low. The patient previously took epinephrine and experienced epinephrine allergy; ciprofloxacin (CIPRO) and experienced Cipro Allergy (eyes closed, got puffy, couldn't breathe); amoxicillin for abscessed tooth and had a reaction because of the sulphites in it; epinephrine (EPIPEN) and experienced epinephrine allergy (does not use it anymore); plantago ovata (METAMUCIL) which she then found out the orange one had sulphites. Historical vaccine included flu shot for immunization and she experienced 104-degree temperature and was sick as a dog and she went to the emergency room (she had flu shot maybe 3 times). Ongoing concomitant medication included multivitamins. The patient got her first dose of BNT162B2 on 29Mar2021 at 11:45. On the same day, once she got home, she became really, really tired/wiped out tired; was so sleepy; experienced sore arm/her arm started to hurt; was nauseous; had sore throat/throat hurt; eyes half closed/eyes closing and puffy face. On 30Mar2021, the patient experienced elevated pulse/her pulse got too high/pulse was 165 beats per minute/climbed up to 195. Her heart rate was 194 at some point for a couple of minutes then stayed at 165 for a long time. She hoped she wasn't having a heart attack. She had tightness in her chest, wasn't feeling good and was coughing. She stayed in her bed to wait out her symptoms. These lasted for 10 minutes (as reported). She started meditating hoping her heart rate would decrease and it did after about 15-20 minutes. The patient also felt feverish/felt hotter than usual. Before she took the vaccine on 29Mar2021, her temperature was at 96. She stated that her temperature usually runs low as 95-06 degrees. She also felt like her sinuses were congested; was sore; had puffy, bubbled up arms, inflamed. The patient hoped it was not a blood clot she developed. At the time of the report, the patient stated that her heart rate was 61 beats per minute, earlier it was in the 70s; and her temperature was at 96.3. Her second dose is scheduled on 19Apr2021 and mentioned that if these were her reactions with the first dose, she is questioning getting the second dose. The outcome of "blood clot", "hoped she wasn't having a heart attack", "Wasn't feeling well", "Tightness in chest", cough, and sinuses congested was unknown. The patient recovered from "Drenched in sweat/sweating/sweating like a dog in the middle of the night", and "Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195" on 30Mar2021; and was recovering from "Sore Arm/her arm started to hurt", and "eyes half closed/eyes closing". The outcome of the remaining events was not recovered. Information on the lot/batch number has been obtained. Additional information is expected.
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| 72 | 2021-04-20 | feeling cold |
Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; ...
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Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; sweats; Freezing; dehydrated; This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ER8732, via an unspecified route of administration, administered in left arm on 25Mar2021 at 16:30 as single dose for COVID-19 immunisation. Medical history included ongoing osteoarthritis. She had severe osteoarthritis and took medication for the arthritis pain. She said she had been taking the osteoarthritis pain medication for a couple years. Concomitant medications were not reported. Patient has no additional vaccines administered on same date of the Pfizer vaccine and has no prior vaccinations (within 4 weeks). Patient with a history of severe osteoarthritis said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Mar2021. The next day on 26Mar2021, she had terrible diarrhea, headache, ringing in her ears, dizziness, fever, chills and sweats. She was admitted to hospital from 29Mar2021 to 31Mar2021. Consumer wanted to know if she should still receive the 2nd dose. She further reported that she got her COVID-19 Vaccine late in the afternoon on 25Mar2021. She said she seemed fine after she got her COVID-19 Vaccine. She said the next morning on 26Mar2021, she woke up with terrible diarrhea, (really bad) headache, ringing in her ears, and dizzy. She said everything went sideways on 26Mar2021. She clarified she also had the chills, was soaking wet with sweat (but never seemed to have a fever). She said she was either sweating, freezing, or shaking with chills. She said she kept having diarrhea. She said on 29Mar2021 she had dry heaves with the diarrhea, and finally went to the Emergency Room. She said while she was at the hospital, she overhead hospital staff saying they thought she had the COVID-19 Virus. She said she treated as if she had the COVID-19 Virus by the hospital staff. She said she had a negative COVID-19 Virus nasal swab test, and the negative COVID-19 nasal swab test had come back within an hours-time on 29Mar2021. She said she was admitted to the hospital because she was dehydrated, and the doctor wanted to make sure she was over her diarrhea and getting better. The adverse events required a visit to the emergency room. She said she was hesitant about getting the second COVID-19 vaccine because of her severe side effects. She had blood work and a urinalysis done at the hospital in Mar2021. Diarrhea and dehydration treatment: Reported she took 3 doses of anti-diarrheal medication on 27Mar2021, and another dose on the morning of 29Mar2021 before she went to the Emergency Room. She said her diarrhea had kind of stopped after the morning of 29Mar2021, because she was unable to provide a stool sample when she went to the Emergency Room. Reported while she was admitted to the hospital, she was given IV fluids. She said she was unsure which IV fluids she was given. Patient reported she had recovered completely from all her reported symptoms in Mar2021.
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| 72 | 2021-04-21 | seizure | 4 seizures over a 2 Week period involving hospitalization. |
| 72 | 2021-04-24 | pain in extremity |
Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racin...
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Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding; Arm barely sore; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 72-years-old , via an unspecified route of administration, administered in Arm Left on 31Mar2021 11:40 am as single dose for covid-19 immunisation. Medical history included ongoing food allergy, she had anaphylactic shock from a food allergy (she was 40 at the time and she doesn't eat anything she is allergic to), sinus infection and then got horrible hives under her eyes. No Prior Vaccinations (within 4 weeks). Concomitant medication was eye drops every night. No additional vaccines administered on same date of the Pfizer Suspect. The patient previously took epipen had two episodes when she was 40. She is bad about carrying her EpiPen, she forgets it. She was allergic to Amoxicillin. At 11:40 am last Wednesday patient had the vaccine, and around 4 or 5 pm, her heart started pounding for 10 seconds, and it felt like forever. An hour later, her heart started pounding again. It happened twice an hour apart and the second time lasted longer. It described as hard pounding. It started at 4 or 5 pm and then for 4.5 hours there was nothing, but then her heart started racing. At around 4 or 5 pm her heart was pounding, than around 9:30 pm her heart started racing and beating fast, she could feel it. She lives in a rural community and her husband called the local fire station and asked if he could take her there, to the station, so that she could have her heart checked. She was hooked up to a monitor and the paramedics said that she had an irregular arrhythmia and needed to go to the hospital by ambulance. Her heart rate was 115 to 130 beats, then 140 beats, at the hospital. It was about 11pm when she was evaluated and then left in the ambulance, as she was 45 minutes from the hospital. The paramedics would have, the arrhythmia, on record and that 5 minutes before she got to the hospital, the paramedic said her heart rhythm was normal. She was not admitted to the hospital, but held in observation and left the hospital at 4:30 in the morning. She hasn't felt anything after that. it was only one time she thought her heart was going faster, after that, but it didn't happen again. It is currently no problem and even at the hospital, the heart racing stopped and it was normal. The doctor in the emergency room said she was totally normal. Her arm was barely sore, when touched, and noticed this when she was being helped to the bathroom in the emergency room, maybe later in the afternoon, it was not hurting. But she didn't have any other events. She was tired the next day on 01Apr2021. She was up all night in the emergency room. people say that one will be tired, as an effect, but she can't say that it is because of the vaccine, or if she only had 3 hours of sleep. She hasn't been sleeping but she can't attribute it to the vaccine. She can't attribute this to the vaccine, that she has been tired lately and not sleeping. Event outcome of irregular arrhythmia and Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding was recovered on 31Mar2021, of Arm barely sore was recovered on 02Apr2021, of the remaining was unknown. Information about Batch/Lot number has been requested.
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| 72 | 2021-04-26 | weakness |
With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors offic...
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With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors office. She saw a PA which told her to drink more water. She experienced Uncontrollable Diarrhea For 18 days. She was sent to Hospital by ambulance on Monday March 15, 2021. She was was treated with an IV and sent home discharged with Weakness. She continued to have Uncontrollable Diarrhea to were she was wearing Diapers. She fell from Weakness on March 16, 2021 to the point where she laid on the floor for an hour and half before she could drag herself up. She went to Hospital on March 18, 2021. Her blood pressure dropped and was admitted to ICU on the March 18th. She started suffering from a Heart attack and was taken back to have a stent put in her wrist to help with possible heart blockage. She went into cardiac arrest and passed away.
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| 72 | 2021-04-27 | pain in extremity |
Slightly sore arm; This is a spontaneous report from a contactable consumer. This 72-Year-old female...
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Slightly sore arm; This is a spontaneous report from a contactable consumer. This 72-Year-old female consumer (Patient) reported that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/expiry date: unknown) via an unspecified route of administration in the left arm as a single dose for COVID-19 immunization on 19Feb2021 at 01:15 PM. The patient's historical vaccine included the first dose of (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/expiry date: unknown) in the left arm on 28Jan2021 at 12:00 PM. The past medical history included Asthma, mitral valve regurgitation, asymptomatic brain cavernoma, high blood pressure. The patients known allergies: PCN, Sulfa, iodine contrast and chocolate. The patient had COVID prior to vaccination. The concomitant medications included Synthroid 88, verapamil, Coreg, calcium/D and zinc. The patient did not have any other vaccines in four weeks. On 19Feb2021, at 12:00AM the patient experienced Slightly sore arm. The clinical outcome for slightly sore arm was recovered. Information about lot/Batch number has been requested.
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| 72 | 2021-04-27 | pain in extremity, tingling, burning sensation |
increased neuropathic symptoms; trouble in her arms.; tingling and burning sensation from shoulder t...
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increased neuropathic symptoms; trouble in her arms.; tingling and burning sensation from shoulder to wrist; tingling and burning sensation from shoulder to wrist; This is a spontaneous report from a contactable consumer (patient) to a Pfizer-sponsored program. This 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247and expiry date unknown, Solution for injection), via an unknown route on 27Jan2021 at 14:15 (at the age of 72-years-old) at single dose arm for COVID-19 immunization. The patient had relevant history of neuropathy prior to receiving vaccine. Concomitant medications was nor reported. On an unspecified date, the patient mentioned that she experienced increased neuropathic symptoms and fair amount of tingling and burning sensation from shoulder to wrist after receiving the first dose. Especially having trouble in her arms between her wrists and shoulder. The patient also felt like burning, stinging, and pins and needles. The patient was scheduled to receive the second dose. Outcome of the events was unknown.
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| 72 | 2021-04-30 | pain in extremity |
It's hard to wash my hair and brush my teeth because my arms hurt/general 24HR a day intense pain in...
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It's hard to wash my hair and brush my teeth because my arms hurt/general 24HR a day intense pain in both arms; joint pain in elbows; acute tendinitis in both arms; she can't straighten her arms out completely, she can't bend them completely/stiff; tennis elbow/golf elbow; right wrist and elbow are swollen up twice their normal size; left arm swelling; It's hard to wash my hair and brush my teeth because my arms hurt/general 24HR a day intense pain in both arms; This is a spontaneous report from a contactable consumer(patient). A 73-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 29Jan2021 (Lot Number: EN5318) at age of 72-year-old at SINGLE DOSE in Arm Right for covid-19 immunisation. Medical history included atrial fibrillation, hypertension from 2010 and ongoing. The patient's concomitant medications were not reported. She was taking her regular prescribed medications which are primary for atrial fibrillation and hypertension, however she has been on these medications for years.The patient previously received first dose of bnt162b2 on 8Jan2021 (Lot Number: EL3246) as SINGLE DOSE in Left arm for covid-19 immunisation. 8 or 9 days later after she received the first dose, she broke out in rash on her upper left chest and shoulder area. It spread, and she then had a patch in the small of her back and then, her legs from her knees to ankles broke out. She reports that after her 1st vaccination she developed a rash 1 week after the injection. Explaining that its a "strange rash some of which I still have on my chest, the small of my back and from my knees to my ankles", The "ones on my legs have never really resolved, its pretty ugly and the dermatologist said it looks like eczema". The doctor gave her some topical steroid cream "Mometaesone" for all of these areas. However, her legs are still not cleared up. She still has lesions there. It looks and is like eczema, but the eczema treatments are not working. For some reason instead of staying as little bumps, the bumps developed into some large, scaly patches. It's those scaly patches that are red and nasty looking which is what the dermatologist has been treating. She was also prescribed Ammonium Lactate lotion which kind of helps with the scaliness that the area produces. The patient received both doses of the COVID vaccine. Both shots were given around 1-2pm. The reaction to the second dose is far more troubling and problematic in all sorts of ways than the first dose. About 7 or 8 days after the second shot, she began to have joint pain in her elbows. She was told she has acute tendinitis and was given oral steroids to take and she was sent to physical therapy. She has had general 24HR a day intense pain in both arms. It's to the point she can't straighten her arms out completely, she can't bend them completely, especially early in the morning when she first wakes up and everything is kind of stiff. She can't even brush her teeth without having to prop her elbow on the edge of the sink. She can't brush her hair, wash her hair without pain. She has to get her partner to undo her bra because she can't. She was given a Medrol pack. With the second one, "My elbows began to hurt, ortho did x-rays and said nothing was wrong with them, and that it may be tendonitis. PT who is a hand and extremity therapist said my swelling is strange and asked if I had Rheumatoid problems. She states she has to go back to dermatologist next week for them to look at the area again. In the mean time, she has taken oral steroids and topical steroids and not much has done any good. She has had reactions autoimmune disorders to both of her vaccinations, the reactions began about a week after getting vaccinated. It was stated that these symptoms are better than dying of COVID but its very unpleasant. She has had X-rays done but it showed there was nothing wrong with her joints. No one has done any blood test. The orthopedic people took X-rays because she told them her elbow hurts. She was told that there was nothing wrong with her elbows, but she does have all this other stuff going on. She clarifies she has tendonitis, tennis elbow, golf elbow- but the hasn't had anything to cause this, and she was told they are really, really bad. Her right wrist is swollen up twice its normal size as is her right elbow. It has been going on now since February, March, April. Her left arm is doing a little bit better but her right arm is pretty acute. She confirms this swelling is still ongoing and persisting in her right arm. The AEs require a visit to Physician Office. Prior Vaccinations (within 4 weeks) was None. AE following prior vaccinations was No. She mentions she was in the military and she received many vaccines from cholera to small pox and beyond. She never had a reaction. The outcome of Joint swelling was not recovered, of left arm swelling was recovering, of other events were unknown. No follow-up attempts needed. No further information expected.
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| 72 | 2021-05-10 | seizure | R56.9 - Seizure |
| 72 | 2021-05-11 | facial pain |
Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) ...
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Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) Last attending ? Treatment team Maxillary fracture Principal problem Final Summary for Deceased Patient Admission Date: 4/14/2021 Discharge Date: 4/22/2021 Final Diagnosis Principal Problem: Maxillary fracture (CMS/HCC) Active Problems: Pneumonia due to COVID-19 virus Demand ischemia (CMS/HCC) Dyslipidemia Essential hypertension Acute kidney injury (CMS/HCC) Glomerulonephritis, IgA Lactic acidosis Septic shock (CMS/HCC) Cytomegalovirus (CMV) viremia (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Left femoral vein DVT (CMS/HCC) Malnutrition (CMS/HCC) Hypothermia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1] COVID-19 virus infection [U07.1] Hospital Course Patient is a 72-year-old female with past medical history of hypertension, hyperlipidemia, recent hospitalization due to CMV viremia and an AKI and myelosuppression. Who presented to the emergency room after a fall in her house on 4/14. She had significant face pain and was hypoxic with an O2 saturation of 68% on room air on presentation. She was then found to be Covid positive. Initially admitted to the medical floor however required increasing amounts of oxygen and was ultimately transferred to the ICU on 4/16. She was maintained on nonrebreather oxygen until the evening of 4/21 when she was intubated and increasing vasopressor requirements. Given her worsening condition, her husband elected to palliatively extubate and pursue comfort care. Time of death was 10:02 AM on 4/22/2021. Disposition of the body: morgue
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| 72 | 2021-05-12 | pain in extremity, burning sensation |
burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched...
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burning between her belly button and breasts; sharp pain in her belly; arm felt like someone punched her; Severe Stomach Pain; stomach pain was unbelievable; So Much Diarrhea; Peeing out of her butt; This is a spontaneous report from a contactable nurse reporting for herself. A 72-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 11:30 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain; stomach pain was unbelievable on 13Apr2021 with outcome of recovering , so much diarrhea; peeing out of her butt on 13Apr2021 with outcome of recovered on 17Apr2021 , sharp pain in her belly on 14Apr2021 with outcome of recovering , burning between her belly button and breasts on 15Apr2021 with outcome of recovered on 17Apr2021 , arm felt like someone punched her on 13Apr2021 with outcome of recovered on 15Apr2021. The patient underwent lab tests and procedures which included blood test: unknown on 26Apr2021. All the reported events were considered Important Medical Events. Causality: Caller stated yes, it is related to the vaccine. Stated she doesnt get diarrhea. Stated she eats healthy and doesnt ever get diarrhea, well maybe once in a blue moon. Caller states she thinks it is totally related to the vaccine. Follow up information has been requested. Lot number was already provided.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 73 | 2021-01-05 | tingling, facial paralysis, numbness, flushing |
The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the pat...
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The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated "probably just nerves". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Eyes: EOM are normal. Neck: Normal range of motion. Cardiovascular: Normal rate and regular rhythm. Pulmonary/Chest: Breath sounds normal. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. Musculoskeletal: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout Skin: Skin is warm and dry. Psychiatric: She has a normal mood and affect.
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| 73 | 2021-01-11 | pain in extremity, weakness |
Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable con...
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Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable consumer (reported for herself). A 73-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 05Jan2021 13:15 at single dose at left arm for COVID-19 immunization. Medical history included High cholesterol, Fibromyalgia, Protein S Deficiency, Anxiety, known allergies: Scallops. Concomitant medications received in two weeks included warfarin, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluoxetine, clonazepam (KLONOPIN), rosuvastatin calcium (CRESTOR), fenofibrate (FENOFIBRAT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, the patient experienced Arm pain, headache, tiredness, extreme weakness. No treatment was received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
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| 73 | 2021-01-15 | numbness | Facial numbness Narrative: |
| 73 | 2021-01-17 | numbness | gait disturbance with visual symptoms for 4 days, numbness of left side of face, flare of cold sore |
| 73 | 2021-01-18 | breast pain, night sweats |
Part of lip went numb right after, started getting nauseous, threw up several times. right breast ac...
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Part of lip went numb right after, started getting nauseous, threw up several times. right breast ached. Slept all day yesterday. since injection no apatite. Had night sweats.
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| 73 | 2021-01-18 | weakness, tingling |
intermittent paresthesias left side of face, left arm and left leg, subjective weakness in the left ...
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intermittent paresthesias left side of face, left arm and left leg, subjective weakness in the left leg
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| 73 | 2021-01-19 | night sweats |
1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping...
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1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping 10-11 hours on both nights. 1/17/2021 Chills and temperatures between 99 and 101.2 degrees 1/18/2021 Temperature of 100.1 degrees in the morning with gradual decline to 98.9 degrees in the evening 1/19/2021 and 1/20/2021 Temperature normal 1/13/2021 to 1/15/2021 Injection site "sore" 1/15/2021 Injection site became hard and painful to the point where I was not able to move the arm without pain at the level of 10 or above which of course limited my use of the arm 1/20/2021 Injection site still painful and difficult to lift or move the arm without pain at a level of 4-5.
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| 73 | 2021-01-19 | tenderness |
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swel...
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Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable effort to swallow.
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| 73 | 2021-01-20 | tingling |
Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got hom...
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Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got home, my left cheek was beet red. That went away in a couple of hours, but left jaw up to my ear still feels strange with intermittent tingling in left cheek and lips. Called dr.
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| 73 | 2021-01-20 | numbness, weakness |
weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two...
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weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two on right chin, slight breathing issue, slight numbness on sides of tongue and between bottom of nose and top of lips,
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| 73 | 2021-01-22 | burning sensation, flushing |
Patient experienced flushing and burning of face ~45minutes after receiving the first dose of Pfizer...
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Patient experienced flushing and burning of face ~45minutes after receiving the first dose of Pfizer vaccine. Patient returned to the clinic because of the symptoms. Patient notes having a similar reaction to prednisone.
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| 73 | 2021-01-24 | weakness |
Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body ac...
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Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body aches and no strength. Caregiver stated on 1/23/2021 patient was having same symptoms with loss of appetite and fatigue. On 1/25/2021 caregiver noticed 2x2 red spot around the injection site that warm sore to touch. Caregiver reached out to the PCP and was told to keep an eye on red spot and put a damp warm rag on it.
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| 73 | 2021-01-24 | tenderness |
Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still ther...
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Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still there at 5 days after vaccination.
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| 73 | 2021-01-24 | pain in extremity | Left arm pain, redness & swelling at injection site |
| 73 | 2021-01-24 | slurring, inability to speak |
STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME...
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STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS
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| 73 | 2021-01-24 | tingling, numbness |
left side of face numb, tingling, redness initially bu gone as of time of call 1/21. Told her to co...
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left side of face numb, tingling, redness initially bu gone as of time of call 1/21. Told her to cont to monitor and get evaluated if did not go away in 24 hours or got worse
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| 73 | 2021-01-25 | tingling |
About 5 minutes afterward had right arm and elbow tingling. About 20 minutes after vaccination had s...
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About 5 minutes afterward had right arm and elbow tingling. About 20 minutes after vaccination had self-described sensation of throat tightness and tongue and lip swelling, and "numbness" but NO tingling. About 1.5 hours and symptoms ~90% better. Plan to continue to monitor until symptoms close to 100% better and patient comfortable going home.
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| 73 | 2021-01-25 | difficulty speaking, pain in extremity |
Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp ...
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Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp pain pain in eyes hoarse throat
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| 73 | 2021-01-26 | numbness | Numbness from forearm down to fingers |
| 73 | 2021-01-26 | cold sweat |
Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood press...
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Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood pressure was 198/91. Per clinical nursing director, EMS called. EMS checked vitals again and blood pressure was 130/82. At that time EMS and patient decided that patient did not need to be transported to hospital at this time. Patient left with husband. At time of departure patient was oriented and reported feeling well.
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| 73 | 2021-01-26 | seizure | Systemic: Seizure-Severe |
| 73 | 2021-01-27 | pain in extremity |
Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely ...
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Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely sore. Joint pain increased, involving shoulders, hands, legs, arms, knees and hips. Left hand began swelling on January 23rd and continued so I could no longer see my knuckles and it ballooned and it was hot and very painful. The knees were so bad it was almost impossible to stand from a sitting position and walking was stiff. Could not sleep laying down because pain in shoulders and knees would increase. I went to the doctor on the 26th. he prescribed Prednisolone for one week and I am scheduled to see him next Tuesday February 2nd.
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| 73 | 2021-01-28 | flushing | Pt. c/o flushing/burning in vaccinated arm, nausea and light headed. |
| 73 | 2021-01-28 | weakness |
This is a spontaneous report from a contactable other health professional. A 73-year-old female pat...
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This is a spontaneous report from a contactable other health professional. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EV0140, via an unspecified route of administration in the left arm on 03Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Simvastatin, Gabapentin, Flonase, Claritin and multi (not specified). The patient previously took codeine and experienced allergy. Within two days (on 05Jan2021), patient experienced headaches, body aches, fatigue, nasal congestion. Strength not yet fully recovered ten days out. The outcome of events was recovering. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 73 | 2021-01-28 | weakness, pain in extremity |
overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, na...
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overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, nausea, dizziness (the last two symptoms were brief)
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| 73 | 2021-01-29 | weakness |
Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep b...
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Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep breaths. Them couldn't get warm. Shivering. Felt fevered but no elevated temp registered. Lasted about another hour. Tired/weak after. Noal next day.
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| 73 | 2021-01-29 | flushing |
at 16:37 making rounds to check on status of vaccination patients . Patient stated "that her mouth l...
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at 16:37 making rounds to check on status of vaccination patients . Patient stated "that her mouth lower lip and tongue were tingling and numb". Notified EMT (on site) patient moved to area of closer observation, Complete assessment . Patient A & O x 3. denies any c/o SOB or Dyspnea. Color wnl, Notified (CN) who immediately came to site of need. Noted at 16:47 Patient appears to have pink circumoral flushed areas around her mouth. Patient also had noted hives on her left upper bicep area. Discussion with (CN) and Paramedic , decision to give 50 mgs of Benedryl. 4:55 PM 50 mgs Benedry l given IM into right Deltoid. Continual monitoring of patient. 5:19 patient stated "I feel much better". Continual monitoring of patient until 5:25PM. Patient discharged home (per her and her son's wish) . Discussion to call 911 or go to ED if condition worsens or returns. Patient recommend to make primary physician aware of incident as well as to take benedryl prior to second dose of vaccine as well as patient to make clinician aware of this occurrence prior to injection..
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| 73 | 2021-01-30 | tremor | Severe chills and shaking, headache |
| 73 | 2021-01-31 | pain in extremity, weakness, feeling cold |
Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had th...
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Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had the chills, needed to sleep. went to bed early around 8 and slept through the night getting up once to go to the bathroom. Has breakfast just toast the next morning and had to get back into bed and slept 4 more hrs. Body still aching. slept with heating pad and iced my arm. I felt a little better the next day around 2 pm. I drank lots of fluids and rested the rest of the day. Next day still felt weak. 3 days later feeling ok. I am worried about my next vaccine due on the 14th of Feb. Would like to know what to take. My doctor referred me to you with no instructions......
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| 73 | 2021-01-31 | weakness, tingling, flushing |
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv...
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Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
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| 73 | 2021-01-31 | feeling hot, pain in extremity |
Redness, heat , swellling ,soreness down whole arm, hot, itching , acheing, tired, arm is still so...
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Redness, heat , swellling ,soreness down whole arm, hot, itching , acheing, tired, arm is still sore. Pt stated Reaction much worse on 2nd Vaccination
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| 73 | 2021-01-31 | pain in extremity | Sore arm with soreness and itching, next day headache and nausea |
| 73 | 2021-01-31 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer (patiet). A 73-years-old female ...
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Sore arm; This is a spontaneous report from a contactable consumer (patiet). A 73-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the Public Health Clinic/Veterans Administration facility, via an unspecified route of administration on 16Jan2021 09:15 AM at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has not had COVID-19 prior to vaccination. The patient did not have any other vaccine in four weeks. Concomitant medication included losartan (manufacturer unknown), levothyroxine (manufacturer unknown), hctz (manufacturer unknown), montelukast (manufacturer unknown, also reported as 'monounsatu'). The patient experienced sore arm on 16Jan2021 at 09:45 AM. The patient did not receive any treatment for the event. The outcome of the event was recovering. The patient has not been tested for COVID-19 post vaccination.
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| 73 | 2021-01-31 | numbness |
Systemic: Other- SOB, light headed, numb hands. Pulse ox was normal. Patient has a history of anxiet...
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Systemic: Other- SOB, light headed, numb hands. Pulse ox was normal. Patient has a history of anxiety.
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| 73 | 2021-02-01 | tingling |
Approx 10:18 am after injection complained of shortness of breath, tingling fingers and toes, dizz...
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Approx 10:18 am after injection complained of shortness of breath, tingling fingers and toes, dizziness. History of asthma. Lungs clear. B/P 163/7; 144/77 and 137/70; Observed and given some sprite. Discharged at 10:52 am.
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| 73 | 2021-02-01 | pain in extremity |
I had injection site area pain, and I found there was a pain with as like bruise on the back side of...
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I had injection site area pain, and I found there was a pain with as like bruise on the back side of left index finger. I don't have any pain at the injection area. About my index finger, It is getting better, but it has still a little pain and a little blue around the second joint area.
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| 73 | 2021-02-01 | tenderness |
Tenderness, warm to touch, red, itchy and then rash on 3rd day after vaccine. Applied ice. Lasted ab...
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Tenderness, warm to touch, red, itchy and then rash on 3rd day after vaccine. Applied ice. Lasted about 6 hrs.
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| 73 | 2021-02-01 | weakness, feeling cold, pain in extremity |
she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chi...
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she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, "do you think I have COVID?" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.
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| 73 | 2021-02-02 | weakness |
Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling naus...
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Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling nauseas and had diarhea and chills which continued through the night and following day. Very weak and passed out briefly when feeding my dogs.Ate a bland diet and drank plenty of water for the next few days. Felt better on Saturday January 30th
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| 73 | 2021-02-03 | tenderness |
PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADA...
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PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADACHE, AND NAUSEA FOR 24 HOURS.
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| 73 | 2021-02-03 | unresponsive to stimuli |
Patient's primary care provider received a death certificate to be signed for this patient. He spoke...
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Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son, who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.
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| 73 | 2021-02-03 | tingling | Systemic: Other- TONGUE, LIPS AND NECK NUMB AND TINGLING-Mild |
| 73 | 2021-02-03 | pain in extremity, cold extremities, feeling cold |
flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ...
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flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
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| 73 | 2021-02-03 | feeling cold, pain in extremity, cold extremities |
the thermometer that marked 100°F orally (she says that the fever was higher in the night); States ...
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the thermometer that marked 100°F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.
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| 73 | 2021-02-04 | flushing, burning sensation |
Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt...
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Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt as though I had a severe sunburn A slightly elevated temperature: normal is 97.3 elevated 98.6 All day 02/01, Partial day 02/02, Redness gone and feeling of burning less severe 02/03 and 02/04. 02/05 a couple of episodes of sensation of facial burning and slightly elevated temp
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| 73 | 2021-02-04 | numbness |
Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious how...
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Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious however the hand numbness improved after 20 mins of rest and relaxation. Initially pt was hypertensive however after resting BP improved
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| 73 | 2021-02-04 | pain in extremity |
tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-year...
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tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-years-old female patient received bnt162b2 (BNT162B2, lot number: EL3302, Expiry Date: 31May2021) via an unspecified route of administration in Left arm on 21Jan2021 10:45 at SINGLE DOSE to gain immunity against Covid-19. Medical history included asthma well controlled Diagnosed 6 years ago. No Prior Vaccinations within 4 weeks. There were no concomitant medications. The patient experienced mildly sore arm on 21Jan2021, tired on an unspecified date. The AEs did not require a visit to emergency room or physician office. The outcome of the event mildly sore arm was recovering. No follow-up attempts possible. No further information expected.
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| 73 | 2021-02-05 | numbness |
73 y.o. female with a history of breast cancer, stroke, and hyperlipidemia who received her second d...
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73 y.o. female with a history of breast cancer, stroke, and hyperlipidemia who received her second dose of the Pfizer COVID-19 vaccine at an outside clinic. Within 10 minutes of receiving the vaccine she developed new numbness and swelling in her tongue, along with numbness in her extremities. She was given 0.3 mg epinephrine per protocol and was then advised to be seen in the emergency department. Her symptoms resolved once she arrived at the emergency department. She was observed for a period of two hours without worsening symptoms and was then discharged. presented to the ED following pfizer vaccine ingestion. received epinephrine IM prehospital for report of tongue swelling and and numbness at the time. She was improved at the time of presentation to the ED. Observed for several hours and discharged home without recrudescent sx. Although cannot find objective evidence of tongue swelling, administration of epi prehospital with report of improvement of symptoms is suggestive that this was a true anaphylactic reaction to the vaccine.
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| 73 | 2021-02-06 | involuntary muscle movements |
Acute intractable generalized abnormal movements. Writhing, choreiform movements x3 days until prese...
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Acute intractable generalized abnormal movements. Writhing, choreiform movements x3 days until presented to hospital. Given Ativan 2 mg IV and Keppra 1g IV with resolution
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| 73 | 2021-02-06 | pain in extremity | Redness, swelling, aching, pain, in the arm where injection was administered. |
| 73 | 2021-02-06 | feeling hot, weakness |
Within 15 minutes started feeling nauseous which has continued, varying in intensity, as I write thi...
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Within 15 minutes started feeling nauseous which has continued, varying in intensity, as I write this. Additionally today, suddenly I started feeling hot and weak. I checked my oxygen level which was fine at 98, but my pulse was fast at 115 when it is normally in the low to mid 70s and I was just cooking. When I took my blood pressure, it was 142 over 125 a blood pressure than is normal for me. I took a table of Inderal 10mg and within an hour my blood pressure was normal at 117 over 86. My pulse was also 73.. So for now I?m ok.
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| 73 | 2021-02-07 | pain in extremity |
Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her ...
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Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; her arm was sore yesterday but better today/her arm was sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing 'sometimes her hip and leg would hurt prior to getting the vaccine'. There were no concomitant medications. Caller received the covid shot on Wednesday, 20Jan2021, her arm was sore yesterday (21Jan2021) but better today (22Jan2021). Caller reports worsening hip and leg pain on 22Jan2021 because sometimes her hip and leg would hurt prior to getting the vaccine. Caller would like to know if it's okay to have taken Tylenol for her symptoms after taking the covid vaccine. Response: The interim ACIP guidelines note that, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot; If you are a patient, you should discuss this with your healthcare provider. Caller would like to know how long the symptoms from the covid vaccine would last. Calling about the Pfizer COVID vaccine she took it on Wednesday (20Jan2021), the Pfizer Biontech, and yesterday (21Jan2021) her arm was sore all day, which is probably to be expected, but today (22Jan2021), she has, her hips and legs feel real achy, she has achiness in her hips and legs, it was asked if that is normal. it was asked if it is a side effect from the shot. Her arm is not like it was yesterday (21Jan2021) if the achiness was a side effect, she thought she may have had it yesterday (21Jan2021), but she didn't, just today (22Jan2021). The outcome her arm was sore yesterday but better today/her arm was sore was recovering. The outcome of other events was not recovered.
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| 73 | 2021-02-07 | unresponsive to stimuli |
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weir...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weird", reported nausea and shortness of breath, and were found to have a blood pressue of 200/96 mmHg despite taking blood pressure medications that day. Patient was transported to the emergency department during which they had a brief episode of unresponsiveness and were non-interactive. On initial exam in the emergency department patient symptoms were improving: speech, sensation, and cranial nerves are intact, normal strength in all extemities, lungs are clear, and there is movement in all extremities. No rash, wheezing, or respiratory distress noted. Repeat vitals within normal ranges except blood pressure 151/87. Patient administered medication for nausea. Symptoms resolved and patient discharged to home stable.
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| 73 | 2021-02-07 | pain in extremity, feeling hot |
Within a few minutes after receiving the vaccine my arm felt stiff and some soreness. Then it fine a...
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Within a few minutes after receiving the vaccine my arm felt stiff and some soreness. Then it fine after I got home and I moved my arm around. It was fine by the next day. Yesterday I ate some shrimp and within the hour of eating the shrimp, I was talking to my son and my head got hot and my ears got really hot. It was itching on my forehead and the front of my neck. I thought something bite me, I went to bathroom. I had big welts on my neck about the size of the quarter and my ears were really red. I told my son that I must have hives, my son told me to take some Benadryl. It eased up after taking the Benadryl, the itching went away but the welts did not go away right away. I took another Benadryl before I went to bed last night. I was able to sleep good last night, it looked pretty much back to normal today, there is one spot left. Today when I got up I don't know how to explain it and I just didn't feel like my normal self. I felt like nervous and shaking. I didn't feel like eating but I made my self eat. I just feel like something isn't right.
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| 73 | 2021-02-07 | weakness | Woke up with chills, fever 101.4, headache, body ache No energy. |
| 73 | 2021-02-07 | weakness |
she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125b...
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she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125bpm; blurry eyes; dizziness; Her blood pressure was also up; In the morning of the 20Jan2021 I was weak; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 19Jan2021 10:02 at a single dose for Covid-19 immunization. Medical history included ongoing Seasonal Allergies (probably started in the last 4-5 years; reoccurs every year from about Oct through Mar), ongoing high blood pressure since like 2006 or 2004, ongoing Iliac artery stent placed started couple of years ago, anxiety from 2010 and ongoing (her cardiologist put her on Xanax around 2010-ongoing). Concomitant medication included ongoing alprazolam (XANAX) since 2010 for anxiety. She gets the flu shot every year and has never had a problem with the flu shot. She got her last flu shot in Oct2020, no adverse events with that or other flu shots historically. On the second dose of Pneumococcal vaccine, it swelled her arm up from the injection site all the way down to her wrist; she went to the urgent care for that. They gave her some medicine and eventually the adverse event went away. She experienced some side effects following that injection. The patient reported that in the morning of the 20Jan2021, she was weak and just kind of rested. She did not have any other side effects until 21Jan2021. At 5am on 21Jan2021, for the whole day she had a fast heart rate, 125bpm, she woke up with her heart rate up, fast heartbeat, then down to 110 and then just toggled a little bit, she had blurry eyes so she could not really focus her eyes, weakness and dizziness. These events continued all throughout 21Jan2021 but her heart rate came down, it was running in the 90s and she was weak all day. Her blood pressure was also up on 21Jan2021. She thinks the blurry eyes, with her eyes being squirrely was related to her heart rate being up and blood pressure being up. She feels like she recovered completely from these events by this morning 22Jan2021. She feels good, strong and her eyes are clear today, felt better than yesterday but not 100%. She has probably shrunk in height, her last known height was 5' 9. She called to ask if she should or should not get the second dose as scheduled for 12Feb2021 in response to the side effects. Outcome of the event 'she has probably shrunk in height' was unknown while the rest of the events was recovered on 22Jan2021. No follow-up activities are needed. No further information is expected.
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| 73 | 2021-02-09 | pain in extremity |
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as w...
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Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg 10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg " and " and nausea 11:30 am severe body aches, chills and fever 99* with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm "
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| 73 | 2021-02-09 | pain in extremity |
sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-o...
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sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at arm at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient asking if one have a sore arm, are one allowed to take Ibuprofen. Female consumer received the first dose of the COVID-19 vaccine today and had a sore arm (25Jan2021). When she received the vaccine, it was administered closer to her shoulder. patient asked what does intramuscularly mean. Outcome of the event was unknown. It was a non-serious report. Information on the lot/batch number has been requested.
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| 73 | 2021-02-10 | tingling |
About 3 days after shot a Small Bump / knot / swelling Appeared; I Massaged & Repeatedly Moved arm ...
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About 3 days after shot a Small Bump / knot / swelling Appeared; I Massaged & Repeatedly Moved arm wSlight Tingling Off & On ( like a DULL toothache; Called a CovidHelp Line & They suggested IF Fever seek further attention However I?ve had No Fever
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| 73 | 2021-02-10 | weakness |
Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited requi...
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Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited required 15 min. w/o reaction. Pt remained for husband's 15 minute wait. During this time, patient felt dizzy and nauseousl and generally weak at 1150. Nourishments provided without relief. Rapid response called at 1155. Team arrived assessed patient. VS179/81 82 pulse, O2 - 96%. Dr. from Urgent Care came to check patient. Told to observe patient and repeat VS, patient ok per Dr. VS repeated at 1215 - 185/92, pulse 84, O2 sat 98%. Patient with c/o pressure to chest, chills and hives. Patient remained stable, husband present. 911 called. EMS Station 28 B shift arrived at 1225 and assumed care of patient. 1245 Ambulance arrived Unit 217 assumed care of patient.
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| 73 | 2021-02-10 | unresponsive to stimuli |
Resident uneventful evening/night. Ate breakfast, baseline status. Found by staff to be unresponsive...
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Resident uneventful evening/night. Ate breakfast, baseline status. Found by staff to be unresponsive at 0945 this AM, almost 25 hrs after vaccine administration. BP at that time 77/30, recheck 81/35. No respiratory distress, oxygen saturations WNL. Remianed afebrile. Over the next hour, she did open her eyes once, but remianed non responsive to staff. Daughter at bedside. Over the next few hours, slowly responding. Was awake and responsive, eating ice cream. PCP has been notified, ongoign onitoring to occur. Spoke to Physican associated with RCAT Care Center. She does infact feel this was an adverse/significant side effect of the vaccination as manifested thru extreme fatugue and exhaustion.
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| 73 | 2021-02-10 | tingling, numbness |
about an hour after vaccine. First left hand weakness. Hand stopped at local grocery store on the wa...
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about an hour after vaccine. First left hand weakness. Hand stopped at local grocery store on the way home. Right hand dominant but use left hand a great deal. Dropped everything I lifted or put in my left hand. Light or heavy. Embarrassed at first, then concerned. Stopped at pharmacy to pick up unrelated med and mentioned to pharmacist. We both laughed. Returned home and told husband. It continued. Later started feeling numbness in fingers and hand on left sixths left leg and numbness and tingling up left neck and face and scalp. Lasted 30 min to an hour. Weakness in hand got better over days . Waited until recently to report it to Anyone and chose Dr as he follows me for other issues and I have a second dose due and became frightened.
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| 73 | 2021-02-11 | migraine, pain in extremity | severe sweating significant migraine fever-low grade muscle pain in thighs |
| 73 | 2021-02-14 | tremor |
Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood press...
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Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy. The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
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| 73 | 2021-02-14 | pain in extremity, tremor |
I woke around 4:45 this morning and I noticed my arm was sore so I got out of bed and had the chills...
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I woke around 4:45 this morning and I noticed my arm was sore so I got out of bed and had the chills. I wrapped up and made some hot coffee, and then made some hot tea. I was also drinking water in between as I felt thirsty but you still could not warm. I was shaking and shivering from the chills. I took two extra strength Tylenol, and with 40 minutes I stopped shaking but I stayed wrapped up as I did not want to get cold again. I went and took my temperature and it was almost 102. I also have a headache, it was like shooting pains in my head and now it feels like a achy fever. I also feel tired.
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| 73 | 2021-02-14 | flushing |
Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the CO...
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Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, rapid progression of symptoms, respiratory distress and skin changes. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 is 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she is no longer lightheaded, headache is almost gone, nausea has resolved. ALLERGY REVIEW OF SYSTEMS: Waves of nausea: Lightheaded with some dizziness, headache: Previous Reactions: Adverse reactions to medications in the past. Objective Vitals Vitals: 02/09/21 1145 BP: (!) 179/63 Pulse: 68 SpO2: 98% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General: No swelling. Right lower leg: No edema. Left lower leg: No edema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and patient took Tylenol before vaccine administration Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Patient feeling back to normal. BP 152/76 at 1203. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She is cleared to drive home. If she should have symptoms return or worsen, she is to call PCP or go to ER.
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| 73 | 2021-02-14 | pain in extremity | fever, diarrhea, headache, sore arm, sore underarm, mouth sores (cheeks, tongue, under tongue, gums) |
| 73 | 2021-02-15 | tingling, speech disorder, numbness, muscle spasms, pain in extremity |
Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hou...
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Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous. Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read) Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
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| 73 | 2021-02-15 | burning sensation | Three days after vaccine on Feb 1 headache, red and burning face and ears |
| 73 | 2021-02-16 | tension headache |
Approximately 36 hours after injection I became dizzy, could not sleep due to constant dizziness, o...
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Approximately 36 hours after injection I became dizzy, could not sleep due to constant dizziness, off-balance and found it difficult to rise from a sitting/laying position without being overcome by dizzy spells. Also felt slight tightness in my head. I begin to take my blood pressure which was well over what was normal for me. BP ranged from highest of 155/84 to 145/78. Blood pressure begin to lower as I begin to take my Blood Pressure medication doubling the dose from 5mg to 10mg Amlodipine. I also take the medication at night, versus my normal routine to take medication during the day. Not sure if this was just a coincident or precipitated by the vaccine.
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| 73 | 2021-02-16 | feeling cold | HA, chilly, muscle pain, joint pain, temp =100 |
| 73 | 2021-02-16 | nerve pain |
Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a...
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Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a pinched nerve. On 2/13 at 2:23pm, my whole L arm broke out in vesicles. Went to ER. Dx with Shingles. Started on Valtrex 1ooomg TID and Prednisone 50mg daily x5 days. V.esicles continued down into my L hand and fingers. Nerve pain continued to be severe. Went back to PCP on 2/16. Started on gabapentin.
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| 73 | 2021-02-16 | pain in extremity |
Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joi...
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Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.
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| 73 | 2021-02-16 | discomfort, flushing | While in observation room, developed uncomfortable flushing feeling. |
| 73 | 2021-02-16 | muscle spasms, paralysis, pain in extremity |
psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible ...
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psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.
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| 73 | 2021-02-17 | pain in extremity, weakness |
At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely d...
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At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.
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| 73 | 2021-02-17 | depressed level of consciousness |
almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; ...
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almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported for two patients. This is the first of two reports. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318 and expiration date 31May2021), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Type 1 diabetic; Alzheimers from 2014 and ongoing, about 7 years ago; and covid-19 from Dec2020 to Dec2020. There were no concomitant medications. At 4 am yesterday morning (03Feb2021), she developed side effects. The patient's husband woke up at 4 am and touched the patient to make sure she was okay like he does every night. When he did, patient was really really hot. He took her temperature it was 101.8. She was almost comatose, and he couldn't get a response from her. He gave her fluid with a straw on her lips. At 7:30 am, 3.5 hours later, she was still hot. He was putting cold compresses on her. He called the hospice nurse, and she came and checked her vitals. She had a fever of 101.5 that time. He continued cold compresses. Her vitals were stable. Then about afternoon, her fever broke, and she became coherent. The rest of yesterday, and today she seems to be fine. She had a side effect that caused her to have a fever and be out of it. He couldn't get a response from her until noon yesterday. When the fever broke around noon, that is when she became more responsive and back to normal. Outcome of the events was recovered on 03Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156644 same reporter/drug, different patient/event
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| 73 | 2021-02-18 | tingling, discomfort, hot flush |
On Day 3 after the shot, I experienced a sensation in the back of my left leg that felt like a shing...
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On Day 3 after the shot, I experienced a sensation in the back of my left leg that felt like a shingles-active area (no rash). Next several days, I have been experiencing hot, heavy, and prickly skin. Not hot externally, just the sensation ? like a constant strong hot flash. No fever. No fatigue. No headache.
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| 73 | 2021-02-18 | weakness, pain in extremity |
She received her first dose of the Pfizer COVID-19 vaccine on 1/7/2021 with the second dose administ...
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She received her first dose of the Pfizer COVID-19 vaccine on 1/7/2021 with the second dose administered on 1/28/2021. She reports that following the second immunization she developed a large red area on the left arm which has since resolved but since less than 1 week after the immunization she has had pain in the left upper arm as well as decreased strength. Pain and decreased strength have not worsened since onset. Pain occurs with movement.
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| 73 | 2021-02-19 | numbness, tingling, burning sensation |
1st COVID Vaccine given on 2/13/2021 and 30 minutes after receiving burning , tingling, and then num...
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1st COVID Vaccine given on 2/13/2021 and 30 minutes after receiving burning , tingling, and then numbness in left side of face and lips. As of 2/20/2021 I still have numbness in the left cheek. I spoke to a doctor and they had no advice to give me because she said that the drug is new.
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| 73 | 2021-02-19 | weakness | fever, headache, extreme weakness and tired |
| 73 | 2021-02-21 | tingling |
After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back a...
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After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back area. Vital signs obtained by EMS. Bp 121/78, HR 82, O2 sat 97%, Blood sugar 120. Client states she feels better and discharged home by EMS.
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| 73 | 2021-02-21 | pain in extremity |
The morning after she got her shot, she experienced sharp pain in thumb. It has been 6 days since s...
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The morning after she got her shot, she experienced sharp pain in thumb. It has been 6 days since she got the shot and she is still experiencing the sharp pain.
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| 73 | 2021-02-21 | weakness |
This is not a critical reaction but want to report in order to help build up the information availab...
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This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
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| 73 | 2021-02-21 | muscle spasms, pain in extremity |
Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 1...
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Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours. Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom. Legs were sore after 18 hours but not cramped . Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM. Extreme exhaustion. Recovering today, Monday. Still tired an s slight residual headache at times but not bad enough for painkiller.
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| 73 | 2021-02-22 | pain in extremity |
After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to ...
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After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to use her Epi-Pen. Did a telemed appointment with her physician who told her to take one dose of the Epi-Pen, Benadryl, Prednisone, Ventolin, and Singulair. These medications have worn off, and wants her to take even more doses of the Prednisone, Benadryl and the inhaler. She is still having symptoms, but improving. She does not itch as badly. Her arm is sore.
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| 73 | 2021-02-23 | tingling, numbness |
About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt n...
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About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt numb or tingly. Very mild. Symptoms disappeared within, say, a half hour and did not return. The following morning I had fleeting head aches on right side - each lasting a' second or so only, and several hours apart. By the afternoon they disappeared. I am having no other symptoms. My arm never hurt at the injection site. I'm not even concerned but feel I should mention this reaction because I will be getting a second shot on March 16. Is it safe? Again, I have no symptoms any longer and feel great.
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| 73 | 2021-02-23 | pain in extremity |
Pfizer COVID 19 vaccine given 01/22/21. Patient reports severe arm pain the following day. She pre...
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Pfizer COVID 19 vaccine given 01/22/21. Patient reports severe arm pain the following day. She presented to ED and was seen by a provider who believes she may have bursitis or tendonitis secondary to the vaccine. I followed up with her 02/16/21 and she is still experiencing severe pain and unable to use that arm. She has an appointment scheduled with an orthopedic specialist 02/18/21 for further evaluation.
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| 73 | 2021-02-23 | cold extremities |
Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and contin...
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Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday slight cramping comes and goes. Feeling much better.
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| 73 | 2021-02-23 | tingling |
pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolv...
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pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolved then on the left then resolved. She also felt like her lungs were feeling weird. This gradually improved over the course of an hour.
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| 73 | 2021-02-24 | weakness |
COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this ...
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COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this month post-covid vaccine # 1, who presetned for feeling sick and SOB. Patient received her second dose of the covid vaccine on 2/19/21, 3 days prior to presentation. The following day, she started having "breathing issues" so she was given a dose of prednisone. 1 day prior to presentation, her breathing had improved but she was feeling generally sick, so she was given tylenol but not pred. Then, today, day of admission, patient was having bodyaches, weakness, headache, and breathing issues again. She took prednisone this morning, but still had to turn up her O2 because her work of breathing kept fluctuating. Admitted 2/22/21 ? 2/24/21.
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| 73 | 2021-02-24 | weakness, muscle spasms, feeling cold |
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch...
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On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
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| 73 | 2021-02-24 | pain in extremity, numbness |
Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 ...
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Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective is a 73 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm/hand numbness . She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: none per pt. Not on any medication. She has not been back to her pcp for "several years". No known hx of htn. She does have a bp cuff at home. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1118 02/25/21 1136 BP: (!) 172/84 124/82 Pulse: 96 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Motor: Motor function is intact. No weakness. Coordination: Coordination is intact. Coordination normal. Gait: Gait normal. Comments: +5/5 strength to upper and lower extremities. Equal facial movement. Psychiatric: Mood and Affect: Mood is anxious (slightly). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved after monitoring. Pt monitored for 20 minutes. She feels well. More like anxiety than local reaction. Pt aware of what to watch for. Education on monitoring bp at home and recommended that she follow up with pcp sometime next week to get up to date on her physical and follow up on bp records she will have done at home. Electronically Signed 2/25/2021 11:33 AM
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| 73 | 2021-02-24 | numbness, tingling, pain in extremity, numbness and pain in extremities, weakness |
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t...
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Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
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| 73 | 2021-02-24 | hot flush, tremor | swelling of face and forehead, hot flashes. tremors pulse rate low, elvevated blood pressure |
| 73 | 2021-02-25 | tingling |
After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling d...
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After about 10 minutes after receiving vaccine patient complained of shortness of breath, tingling down to her fingers and feeling strange. I gave her 1 dose of EpiPen at site of injection. She did start feeling a little better. Paramedics came and she was transported to the hospital. I did speak with her later and she was feeling better. She did tell me that they didn't think it was an anaphylaxis reaction but a reaction to the vaccine
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| 73 | 2021-02-25 | flushing, numbness |
Client c/o numbness and hot flush to the face w/slight lightheadedness. Client verbalized that she ...
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Client c/o numbness and hot flush to the face w/slight lightheadedness. Client verbalized that she had not had anything to eat or drink due to nervousness of vaccine. Client seen and assessed by EMS. Vital signs are BP 132/70, HR 90, o@ 99. Client advised to drink and eat snack that she had in the car. After snack, client cleared to go home by EMS. Client also advised to seek medical attention if symptoms worsen.
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| 73 | 2021-02-25 | weakness |
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ...
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Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
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| 73 | 2021-02-25 | discomfort |
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain an...
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Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort. Also had a headache for most of the day on the second day. Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased. Day Six it is still itchy, red, hot and swollen. Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
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| 73 | 2021-02-25 | weakness |
ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching i...
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ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say "ohhh, I can't lay that way". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment "I'm sorry, I'm choking on my cough". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.
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| 73 | 2021-02-26 | bell's palsy, slurring |
Day after second dose symptoms thought to be a stroke occurred. Patient was given a clean bill of h...
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Day after second dose symptoms thought to be a stroke occurred. Patient was given a clean bill of health at ER in hospital. Following day 2/16/2021 patient went to clinic to find out why face was dropping and speech was slurred. Primary Care Provider diagnosed patient as having Bell's Palsy (see physicians report).
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| 73 | 2021-02-26 | feeling hot, flushing | Itching from head to toe; high blood pressure; flushed and warm |
| 73 | 2021-02-26 | feeling hot, pain in extremity | Low grade fever, headache, fatigue , arm pain and heat. |
| 73 | 2021-02-26 | flushing |
PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLV...
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PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLVED WITHIN 30 ADDITIONAL MINUTES .
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| 73 | 2021-02-26 | night sweats |
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no tast...
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extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
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| 73 | 2021-02-27 | discomfort |
Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Ch...
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Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: DEATH-Severe, Systemic: Heart Attack-Severe
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| 73 | 2021-02-27 | pain in extremity | Sore arm for 24hrs, chills and low grade fever (99.1). 28 hrs |
| 73 | 2021-02-28 | pain in extremity, weakness |
Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by ...
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Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by slight headache for several days.
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| 73 | 2021-02-28 | discomfort |
I developed a rash (in the evening and continued all night). The instructions I received was to see...
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I developed a rash (in the evening and continued all night). The instructions I received was to seek medical attention. I went to Urgent Care at 8 AM on Feb.25. I was instructed to take one tablet Claritin and then 2 Benedryls in the evening. By 5:30 PM on Feb 25 I was extremely uncomfertible and took two benedryls. Still could not sleep and at 11:30 PM took 2 more benedryls. When I woke up at 7:30 AM on Feb 26, the rash was gone and has been gone since. I was also instructed not to take the second shot. (Which I will not)
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| 73 | 2021-02-28 | pain in extremity |
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus...
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Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
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| 73 | 2021-03-01 | numbness, tingling |
After 1st dose of Pfizer Covid vaccine Received on 2/25/2, 20 mins later noted mosquito bite size hi...
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After 1st dose of Pfizer Covid vaccine Received on 2/25/2, 20 mins later noted mosquito bite size hive on upper extremities. 6 hours later hives appeared on all extremities but not face or body truck. No airway and facial involvement. Pt states hives are not painful but pruritic. Also has some numbness and tingling. As of today 3/2/2021, all hives resolved. Finished prednisone course today. Taking Benadryl along with prednisone.
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| 73 | 2021-03-01 | pain in extremity |
Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous...
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Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 73 | 2021-03-01 | bell's palsy | Bells Palsy |
| 73 | 2021-03-01 | weakness |
Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1...
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Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1. Extreme weakness and nausea. Had no appetite. Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
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| 73 | 2021-03-01 | muscle spasms |
I started having lower back pain within hours of the 2nd shot, along with major headache, exhaustion...
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I started having lower back pain within hours of the 2nd shot, along with major headache, exhaustion By that night I had chills, exhaustion, back pain Since then, my back has been in spasm. Extremely, extremely painful spasm The pain is not movement related. I am fine while sleeping and generally while walking. Sitting or standing still brings on the pain
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| 73 | 2021-03-01 | flushing |
Patient presented today for second dose of COVID vaccine. She tolerated her first dose well. She has...
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Patient presented today for second dose of COVID vaccine. She tolerated her first dose well. She has h/o elevated BP and "flushed" feeling with various meds including once when she was doing a bowel prep for a colonoscopy. We decided to monitor her for 30 minutes and she felt fine throughout. As she was walking to her car she felt "flushed" and a bit light headed so she returned to the monitoring area. Initial BP was 189/77, pulse 110, O2 sat 100%. We brought her to the back room so she could sit in a recliner and remove her mask. Subsequent BP 186/77, pulse 86 then 184/69, pulse 80 about 20 minutes later. O2 sat remained upper 90s to 100%. She continued to report feeling "flushed" and noted pressure/pain behind her left eye so we elected to call EMS (and this was also patient request to go to the ED) so she could be evaluated. She drove herself to appointment. Her plan was to call her son to have him meet her at the ED. She left via ambulance in stable condition.
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| 73 | 2021-03-01 | flushing | SOB, facial flushing, observed by EMS-cleared |
| 73 | 2021-03-01 | difficulty speaking |
Throat swelling, which developed gradually by the evening on the day patient received Pfizer 1 injec...
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Throat swelling, which developed gradually by the evening on the day patient received Pfizer 1 injection COVID 19 vaccine on Feb25. Patient did not report reaction until appointment today March 2. Patient reported slight improvement, but still had hoarseness and dyspnea during phone interview. Prescribed Medrol DosePak.
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| 73 | 2021-03-02 | feeling cold, feeling jittery |
Chronic fatigue and feeling cold like I can't get warmed up, but no fever, tense, jittery feeling wi...
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Chronic fatigue and feeling cold like I can't get warmed up, but no fever, tense, jittery feeling with the coldness and fatigue gets worse as day goes by. Hard to rest and relax because of the cold and tense feeling This lasted the entire 3 weeks between dose 1 and dose 2. I got dose 2 on Feb. 19 and have had same fatigue that isn't going away. Fatigue and coldness is not worse with 2nd dose, but I heard that side effects were only supposed to last a few days. To get warmed up I feel like I have to take a hot bath which also helps the tension. Also later in the day I feel like I can't move properly, I just have to stay still, moving is too much of an effort.
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| 73 | 2021-03-02 | flushing |
Facial flushing in recovery area. no respiratory distress or itching. Pt given Benadryl 50 mg PO. VS...
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Facial flushing in recovery area. no respiratory distress or itching. Pt given Benadryl 50 mg PO. VSS. Patient refused transport to hospital. Husband was a previous EMS and wanted to take her home.
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| 73 | 2021-03-02 | migraine, weakness |
Headaches that have continued to get worse and have become like visual migraines. Have only been ha...
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Headaches that have continued to get worse and have become like visual migraines. Have only been happening once a day but the lingering headache and weakness in body continues through the day. With lots of fatigue.
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| 73 | 2021-03-02 | weakness, tingling |
rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week fe...
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rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week feeling
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| 73 | 2021-03-03 | pain in extremity |
Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed...
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Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed aches, chills and low grade temperature. Became lightheaded. Could not sleep due to symptoms. No appetite but drank herbal tea and water with added electrolytes. That severity of symptoms lasted until 3/4 at 6 AM. Still am having some residual effects as one might have with the flu ? fatigue etc. Temperature is gone no more chills appetite still diminished.
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| 73 | 2021-03-03 | pain in extremity, tenderness |
Day of shot my left arm felt sore and also my left arm pit. By evening it was so sore it hurt to m...
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Day of shot my left arm felt sore and also my left arm pit. By evening it was so sore it hurt to move arm or touch arm pit. Morning after 1 PM second shot, my left eye was almost completely covered in blood. My arm pit also very sore and found a bruise on the side of my left breast and also on my left hip. I slept a lot and by the next day everything eased up. After another day my eye was clear and bruises fading. The last thing to go away was the soreness in my left arm pit.
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| 73 | 2021-03-03 | sensory loss |
She was in her usual state of health until January 26 when she received her first dose of the Pfizer...
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She was in her usual state of health until January 26 when she received her first dose of the Pfizer COVID-19 vaccine and the second dose on February 18, 2021. Within 4 days of receiving this vaccine she noticed she fell on Monday, February 22 she was able to raise herself up she fell again on Tuesday, February 23 and on Thursday, February 24. By Friday she could not get up and she presented to hospital where she was noted to have lower extremity weakness. An MRI has revealed extensive edema of the whole of the spinal cord extending from the cervical region to the sacral area. She has lost motor function and sensation to the lower extremities as well. She has not had a bowel movement since Thursday, February 24 and she has had to have a Foley catheter placed because of difficulties passing urine.
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| 73 | 2021-03-04 | muscle spasms |
March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symp...
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March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symptoms that had been in remission were now present. no strength in left injection arm, all muscles weakened. slight headache. All subsided about ten pm.
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| 73 | 2021-03-04 | pain in extremity |
My reaction was not bad enough to require medical attention but I am reporting it to add to the data...
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My reaction was not bad enough to require medical attention but I am reporting it to add to the data base. A few hours following the vaccination, my eyes burned like crazy. The day after my second dose of the vaccine, I became excessively fatigued. My arm hurt, I had a very slight fever (99.2 and my normal temp in 97.6) and felt a general malaise. I went to bed and after 10 hours of sleep felt much better the following day, although still fatigued. However, the next day, my arm hurt to move it and I discovered swelling under my arm and my lymph node was enlarged. The swelling went down after a couple of days and all of my symptoms were gone in about five days.
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| 73 | 2021-03-04 | pain in extremity |
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulde...
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Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel). Blooming painful pustule rash from shoulder to wrist on inner arm for one week. Post-herpetic and muscular pain continues through rash scabbing and drying, to date March 6, 2021. This is my second event in 37 years.
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| 73 | 2021-03-05 | pain in extremity | Headache, pain in both eyes, sore right arm. |
| 73 | 2021-03-05 | feeling hot | Hot sweaty thirsty Slight nausea At night whole body chills Whole body shivers Fever |
| 73 | 2021-03-05 | bell's palsy |
I have developed bell's palsy. I am not sure if that is due to the Pfizer vaccine. Otherwise, I ...
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I have developed bell's palsy. I am not sure if that is due to the Pfizer vaccine. Otherwise, I am in excellent health.
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| 73 | 2021-03-06 | weakness |
2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, a...
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2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, arm rashes shoulder to wrist. Body aches and bad weakness for about a week. Rashes on arm and swollen arm lasted 9 days.
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| 73 | 2021-03-06 | muscle twitching |
Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some fo...
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Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some foggy thinking. this is day 10 headache duller now but other symptoms present
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| 73 | 2021-03-07 | hot flush |
3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5:...
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3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5: Morning; headache, fatigue Evening/overnight: arm still tender 3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset. Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache Evening/overnight: not getting restful sleep 3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected. 3/8 continues to be nauseous, lack of appetite and extreme fatigue.
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| 73 | 2021-03-07 | pain in extremity |
Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next m...
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Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next morning after Covid shot, my blood sugar was 350. It continued that way for days. I started using more insulin the night before (when I usually take it). So I HAD been taking only 45 units at night. I was cautious and increased to 65 units on the 3rd night. That reduced my morning blood sugar readings to 220. Per my doctor's instructions, I have been taking that amount every night, but my blood sugar has only gone down to 175. This was my MAIN concern. But here are the other physical effects that have occurred since 2-25: great thirst, Joints hurt, teeth hurt, confusion, headache, fatigue, sleeping almost all day - all of these days since the shot. Something new started just last night (3-7-2021). Both of my legs hurt so much I could not fall asleep. They still hurt this morning. My joints ache in my hips, knees - Much worse than they normally do.
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| 73 | 2021-03-07 | weakness | Weakness, nausea, fever. Symptoms lasted approximately 36 hours. |
| 73 | 2021-03-08 | seizure, one side paralysis, grand mal seizure, slurring, depressed level of consciousness, speech disorder, facial paralysis |
73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) ...
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73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312. In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something. Observer asked pt if she was ok. Patient nodded yes. A minute later, the patient dropped her purse and mumbled something. Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help. Vitals, glucose and oxygen was placed on patient. EMS was called. Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
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| 73 | 2021-03-08 | feeling hot |
Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactab...
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Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 23Jan2021 at 11:30 AM (at the age of 73 years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium, hydrochlorothiazide/losartan potassium. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 at 16:00 PM, the patient experienced arm red and hot. On an unspecified date the patient experienced the injection site is very itchy. No treatment was given for the events. The clinical outcome of arm red and hot was not recovered. The clinical outcome of injection site is very itchy was unknown. . It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 73 | 2021-03-08 | tenderness | fever, body aches, chills, fatigue, tender arm |
| 73 | 2021-03-08 | tremor |
no pain at left arm at injection site but left arm tremor started approximately 8 hrs after injecti...
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no pain at left arm at injection site but left arm tremor started approximately 8 hrs after injection and developed into body chills, fever up to 102 degrees, body aches and pains which continued for 17 hrs and then resolved with only OTC home treatment
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| 73 | 2021-03-09 | tingling |
Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle ...
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Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle area. Unlike shot #1 on 02/16/21, where I could not even feel the needle in my left arm, this injection into my shoulder was immediately painful. As the day progressed, my upper arm had to be massaged to reduce the pain, my wrist and fingers tingled, and I could not use my right arm for normal activities. Overnight, I had difficulty finding a comfortable position for sleeping. I fear a bursitis condition will develop requiring further treatment.
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| 73 | 2021-03-09 | tremor |
Pain in my heart. Lasted 15 minutes. Took zanax and it went away. Also very bad trembling in my ha...
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Pain in my heart. Lasted 15 minutes. Took zanax and it went away. Also very bad trembling in my hands. Worse than usual.
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| 73 | 2021-03-09 | pain in extremity | Severe headache, slight nausea, very sore arm, tiredness. Lasted through the day and evening |
| 73 | 2021-03-10 | weakness |
Severe vomiting and diarrhea for 12 hours. Received shot at center. Called at noon on 3/10 and got...
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Severe vomiting and diarrhea for 12 hours. Received shot at center. Called at noon on 3/10 and got prescribed ONdansetron 4MG. The vomiting stopped about an hour later. Am still weak this morning. VERY concerned about getting second shot.
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| 73 | 2021-03-11 | burning sensation, pain in extremity |
Left arm burns and aches. Has not stopped even with icing and heat sine day after shot. March 4 fo...
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Left arm burns and aches. Has not stopped even with icing and heat sine day after shot. March 4 forward
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| 73 | 2021-03-11 | pain in extremity |
Sore arm as expected. Fatigue (still in effect, ) Severe headache ( helped/resolved by Tylenol). Som...
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Sore arm as expected. Fatigue (still in effect, ) Severe headache ( helped/resolved by Tylenol). Some queasiness/dizziness
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| 73 | 2021-03-11 | tingling |
Tingling in chest. Chest tight. VSS. Observed and symptoms resolved within 20 minutes. Released hom...
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Tingling in chest. Chest tight. VSS. Observed and symptoms resolved within 20 minutes. Released home
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| 73 | 2021-03-11 | numbness |
numbness to right arm following injection that has subsided but has left pain in the deltoid and rig...
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numbness to right arm following injection that has subsided but has left pain in the deltoid and right wrist. also noted elevated heart rate after leaving the clinic. refuses to go to pcp due to risk of COVID
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| 73 | 2021-03-11 | pain in extremity |
shortly after injection was provided left arm pain 2:45PM. 6:00 AM Headache 6:00 took Aleve 220mg ...
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shortly after injection was provided left arm pain 2:45PM. 6:00 AM Headache 6:00 took Aleve 220mg for arm pain, headache 3:30 PM arm pain, fever, headache, body aches, fatigue 5:30 PM Aleve 220 mg for symptoms
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| 73 | 2021-03-12 | seizure |
Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previ...
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Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previous seizures or seizure disorders.
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| 73 | 2021-03-12 | weakness |
nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination -...
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nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination - bladder and kidneys, extreme weakness, no interest in food.
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| 73 | 2021-03-14 | pain in extremity |
Date and time of vaccination: (list both if they received both shots):? 2/10/21 first / second 3/3/...
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Date and time of vaccination: (list both if they received both shots):? 2/10/21 first / second 3/3/21 Brand and lot of vaccine: Pfizer first EL9262 / second EM9810 2/10/21 first dose sore arm later the night Caller concerned she did not watch the second vaccine go in, the nurse doing it seemed distracted. Since she has had no post vaccine symptoms concern she did not get the dose. Advised all doses are accounted for. Many have not had any symptoms after getting the vaccine.
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| 73 | 2021-03-14 | numbness |
L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontan...
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L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontaneous report from a non-contactable other-HCP. This other HCP reported for a 73-Years-Old (same age at vaccination) female patient that she received the first dose of bnt162b2 (BNT162B2, Lot number EN6205), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication was none. She had not been back to her pcp for "several years". No known history of HTN. She did have a blood pressure cuff at home. During her 15-minute waiting period after the injection on an unspecified date, the patient began to experience L arm/hand numbness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Treatment included: no therapy. Follow up response was excellent. Patient discharge: stable to go home and follow up with PCP. Outcome of events was unknown. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information provided, and on a close drug-event temporal association, the Company assessed there was a reasonable possibility that the reported serious events were related to the suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-03-14 | numbness, tingling |
The right side of my face was numb and felt uneven, my throat felt very dry, tingling in my right si...
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The right side of my face was numb and felt uneven, my throat felt very dry, tingling in my right side of the body. No treatment the symptoms went away within two hours. However, the right side of my face feels tight not numb.
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| 73 | 2021-03-14 | weakness |
chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and tol...
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chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and told it will go away in a couple of day. Stayed in bed all day on the 12th of March and woke up about 8:00 on the 13th and only symptom which I still have today is sore arm at point of vaccination. other meds Lorazepam .05mg,Aspirin 81 mg, Acyclovir 400 mg, Vita D, Vita B12,Align, Estroven. Turmeric, One a day vitamins,Coq10
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| 73 | 2021-03-15 | pain in extremity | Arm swollen -- and slight pain |
| 73 | 2021-03-15 | tingling | Facial tingling |
| 73 | 2021-03-15 | tingling, throat numbness |
In first 15 minutes, no adverse reaction. In second 15 minutes, while driving home, my lips, throat,...
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In first 15 minutes, no adverse reaction. In second 15 minutes, while driving home, my lips, throat, nasal passages began to go numb, tingle, swell. This lasted a day and a half. No breathing obstruction.
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| 73 | 2021-03-15 | flushing |
pt. is alert but complain of light headache and flush. VS BP 151/106, HR 97. symptoms was resolved...
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pt. is alert but complain of light headache and flush. VS BP 151/106, HR 97. symptoms was resolved and patient went home.
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| 73 | 2021-03-16 | weakness |
11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavende...
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11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavender splotches when eyes open; no strength in arms or legs: collapsed trying to get out of bedroom to bathroom & couldn't get up unassisted; collapsed again trying to get from bathroom back to bed - couldn't scoot or pull/raise myself up with my arms; needed help to sit & rest& collect myself; arms/legs had no strength at all.... couldn't move unassisted; took unknown amount of time for husband to help me back to bed....once in bed slept until 6AM.. still weak the following day but vision back to normal - used walker to get around..head still buzzing
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| 73 | 2021-03-16 | numbness |
Client c/o numbness in the jaw. Client seen and assessed by EMT and vitals are BP 120/80, HR 78, O2...
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Client c/o numbness in the jaw. Client seen and assessed by EMT and vitals are BP 120/80, HR 78, O2 98%. During assessment client stated that she had the same reaction when first dose was received. Client advised to contact PCP if symptoms worsen. Client verbalized understanding.
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| 73 | 2021-03-16 | weakness | Fever, Chills, Vomiting, Weakness, Tired, Rapid Heartrate |
| 73 | 2021-03-16 | pain in extremity |
Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, ...
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Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, neck, back hips, upper legs), lethargic. Sore throat resolved within a 8 hours. Fever resolved within 24 hours. Muscle pain still in progress 33 hours later. Have not taken any OTC treatments because I do not want to impede the vaccine's work.
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| 73 | 2021-03-16 | facial paralysis |
right facial drooping including right forehead, no other neurological deficits symptoms started on 3...
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right facial drooping including right forehead, no other neurological deficits symptoms started on 3/13, no significant changes since onset
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| 73 | 2021-03-17 | burning sensation |
Pt. stated she started feeling a burning sensation 5 minutes after getting vaccinated, the burning s...
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Pt. stated she started feeling a burning sensation 5 minutes after getting vaccinated, the burning sensation moved to her chest and then to her legs and it went away on its own. At 10:47 am pt. stated she is feeling OK and wants to go home.
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| 73 | 2021-03-17 | feeling hot | Tongue tingling, face hot, red nose |
| 73 | 2021-03-17 | pain in extremity |
Within the first 15 min. a sharp pain was felt in my upper arm about six inches below the injection ...
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Within the first 15 min. a sharp pain was felt in my upper arm about six inches below the injection sight. The pain subsided and I thought no more about it. My arm was sore for about 5 days. I was extremely tired the first day or so and took a day time nap the next day which is unusual for me. I felt lethargic for two weeks and went into what I call a funk - a very minor depression. Exactly two weeks later the funk lifted and I felt normal. I received my second shot on 2/19/21. About that time (can't remember if it was before or after the second shot) I felt a sharp pain in my left arm in the same spot where the initial pain was. I massaged my arm and took Tylenol and that was the end of it. I've had a couple of other episodes since with less discomfort each time. I have simply massaged my arm and it's gone away. After the second shot I slept for about 2 to 3 hours in the afternoon the next day. I felt somewhat lethargic for a few days and a minor funk for a few days, but nothing more. The pain in my arm is the unusual symptom. I broke that arm just below the elbow two years ago. I don't know if that might have anything to do with the situation or not.
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| 73 | 2021-03-17 | feeling hot |
could taste metal in my mouth; get over heated and breathing slightly difficult; get over heated and...
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could taste metal in my mouth; get over heated and breathing slightly difficult; get over heated and breathing slightly difficult; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EL8982) via an unspecified route of administration at left arm on 16Feb2021 at 01:15 PM at a single dose for COVID-19 immunization. Medical history included allergies to medications, food, or other products: dairy and pineapple. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EL8982) at left arm on 29Jan2021 at 01:15 PM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) and vitamin D nos. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. As soon as the nurse started to administer the shot the patient could taste metal in her mouth. Within minutes she started to get over heated and breathing slightly difficult. She opened all the windows in the car and reminded herself that she was breathing and could blow the horn at any time. Difficulty breathing lasted minutes but the overheating about 20 minutes. Once she cooled down all symptoms disappeared. Adverse event start date was reported as on 16Feb2021 at 01:15 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolved on 16Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 73 | 2021-03-17 | feeling cold |
while sitting and waiting the 15 minutes after the vaccine was administered I felt this cold sensati...
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while sitting and waiting the 15 minutes after the vaccine was administered I felt this cold sensation go from my feet up my legs throughout my body. It felt like an injection of dye(Iodine). I didn't feel cold, I just felt a cool sensation spread over my whole body.
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| 73 | 2021-03-18 | numbness |
Numbness in forehead, Headache and metallic taste in the mouth. Event only lasted about 30 seconds t...
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Numbness in forehead, Headache and metallic taste in the mouth. Event only lasted about 30 seconds to 1 minute. After that event went away.
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| 73 | 2021-03-18 | hot flush |
Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot ...
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Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot flashes including drenching sweat , red neck and face and raised blood pressure. This occurred randomly. It was an almost daily event until 3/5/2021. This then reduced to 1 event every 2-3 days until the present. Last occurred on 3/18/2021.
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| 73 | 2021-03-19 | tremor, migraine |
3 hours after extreme nausea. 10 hours after shaking chills(rigors) lasting in waves for 6 hours the...
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3 hours after extreme nausea. 10 hours after shaking chills(rigors) lasting in waves for 6 hours then intermittently for 5 hours. Low grade Temp 100.3 Degrees , when I could take it. Inconvenience of urine during the rigors. ?Migraine like? headache on right side involving my teeth for 12 hours and slowly abated after 24 hours. Unable to eat or drink for 42 hours with exception of one cup green tea and 1/2 slice of provolone cheese., forced down only to take my Pradaxa. After rigors, whole body sweats for 8 hours. As of today, I have had plain oatmeal and tea.
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| 73 | 2021-03-19 | tenderness |
Skin rash (red, raised) around neck, chest, face. Red, raised and puffy, extremely itchy, tender. ...
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Skin rash (red, raised) around neck, chest, face. Red, raised and puffy, extremely itchy, tender. The rash started in several spots which have then grown in size and merged in a couple of areas. I had one patch of the same rash a couple of weeks after the first vaccination . It lasted a couple of days and wasn't as severe as this time. My internist thinks this is due to the vaccination -- other possibilities (eg bug bite) are not at all likely. Treating with antihistamines and topical cortisone - which are minimally effective so far.
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| 73 | 2021-03-19 | pain in extremity | Sore right arm, fever, nausea chills, rash, headache |
| 73 | 2021-03-19 | weakness |
Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills...
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Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills and felt weak. Went to bed with normal covers, spread and an extra quilt. Temperature was 101.0. stayed in bed until noon then went to the couch. Still felt weak and extremely tired. Temp down to 99 but developed a bad headache. Took Tylenol and laid on the couch all day - did not eat still felt queasy. Went to bed around 8:00pm. Got up about 10:00 on Friday and felt almost back to normal and got better as the day went on. I also noticed quite a bruise at the site.
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| 73 | 2021-03-20 | weakness |
3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no lo...
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3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no longer stay awake, slight aching at injection site 3/12 slept 10 hours, continue to feel tired, less energy to present date 3/21/21.
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| 73 | 2021-03-20 | weakness |
Extreme unremitting weakness, unable to walk without aid for 8 days. blood tests negative on 4th da...
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Extreme unremitting weakness, unable to walk without aid for 8 days. blood tests negative on 4th day. On 8th day neighbor said mother also collapsed and her ER said it was blood clots from the vaccine and gave her aspirin. Exactly one hour after my wife took 325 mg of aspirin, all of her vigorous strength had been restored.
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| 73 | 2021-03-20 | speech disorder |
disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for in...
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disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for instance as a result of flu. She recovers in a few days. This is NOT a stroke or heart related event.
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| 73 | 2021-03-21 | pain in extremity |
Evening of administered dose sore and itchy arm. Woke up the morning after injection (3/18/2021) had...
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Evening of administered dose sore and itchy arm. Woke up the morning after injection (3/18/2021) had tired feeling of eyes, white of left eye appeared to have bleeding across entire bottom area as well as up both sides, top area remained white in appearanceor bleeding was unresolved in three weeks AS
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| 73 | 2021-03-21 | hot flush |
Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm....
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Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm. At 2:am next morning, March 17, sudden severe nausea and diarrhea, severe headache, hot flashes and sweats continued for 2 hours. Intermittent syncope twice.
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| 73 | 2021-03-21 | pain in extremity | arm and shoulder pain f/u call made; caller reports decrease in intensity of arm and shoulder pain |
| 73 | 2021-03-22 | tingling, feeling jittery |
Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history signifi...
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Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer. She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine. Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness. She was given 50 mg oral Benadryl in the ED. Patient then complained of tingling sensation throughout her body and was continuously coughing. She was brought to the emergency department for evaluation. Patient noted she felt jittery and "disconnected". In the ED her cough and dizziness significantly improved. Upon examination, patient was noted to have right lower extremity weakness. She denied any weakness. CT of the head was performed to rule out stroke. Neurology was consulted. CT head brain was negative however patient was still having right-sided weakness. Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine. It was determined she was within the window for TPA. Patient was transferred to the ICU for further management.
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| 73 | 2021-03-22 | flushing | Swollen arm with redness and rash Swollen face, throat, feet, hands, flushing Shortness of breath |
| 73 | 2021-03-22 | muscle spasms | painful arm that received the vaccine, gas and cramping, headache, fatigue, stiffness |
| 73 | 2021-03-22 | muscle twitching, seizure |
seizure; twitches jerks; This is a spontaneous report from a contactable consumer (patient) via Medi...
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seizure; twitches jerks; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW6205), via an unspecified route of administration on 25Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, diabetes, seizure disorder, and was put on continuous positive airway pressure (CPAP) machine. Concomitant medication included unspecified medication for high blood pressures. Patient stated that her blood pressures are normal but she was on medication for it. The patient previously took phenobarbital for seizure. The patient got the first dose of the vaccine on 25Feb2021 and later that day, the patient had a seizure and was in the hospital for days. The patient was put back on seizure medication, Keppra. It was further reported that patient was diagnosed with a seizures disorder when she was 20. She haven't had a seizure probably in 40 years and she was put on a CPAP Machine and she started getting good sleep and she was able to go off all seizure medicines about 10 years ago. The patient got the first shot on the 25Feb, she sit around for 15 minutes and no adverse reactions. She went to lunch with her sister and started having like what she call twitches jerks (not clarified) and she went home and little bit later that afternoon she had a major seizure and had to be taken to the hospital and there she stayed about 4 days. Now she was home and back on her seizure medication (further clarified as Keppra). The patient was hospitalized for seizures on 25Feb2021 and was discharged March 1st or 2nd. Additionally, it was reported that patient had a bunch of laboratory test (unknown results) in the hospital. Electroencephalogram (EEG) and magnetic resonance imaging (MRI) were performed with unknown results. Therapeutic measures were taken as a result of seizure which included Keppra. The outcome of the events was unknown.
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| 73 | 2021-03-23 | tremor |
About 9.5 hours after the injection, I started feeling a bit shaky. Seemed to be on left side of che...
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About 9.5 hours after the injection, I started feeling a bit shaky. Seemed to be on left side of chest. Shakiness got stronger and stronger, spread across chest and into head. By 10 hours after injections, hands were shaking, voice, was shaking, teeth chattering. The worst lasted about 20 minutes, and then started to subside in reverse order ending on left side of chest. By 90 minutes after initiation, all shaking was gone. During the worst of it, I could sometimes control the shaking briefly with slow breathing. But then shaking would return. Fitful sleep through the night. Aches and low fever next day.
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| 73 | 2021-03-23 | tingling, numbness |
Spike in blood pressure and numbness/tingling down arm within minutes after the injection. The follo...
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Spike in blood pressure and numbness/tingling down arm within minutes after the injection. The following morning, swelling on face and jaw as well as inside and around the mouth, including the tongue. Took Benadryl to relieve symptoms.
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| 73 | 2021-03-23 | weakness | Weak, aching, chilling |
| 73 | 2021-03-23 | pain in extremity |
started about 15 hours after dose # 2 on 18Feb2021.I had flu like symptoms.; achy legs; achy back; ...
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started about 15 hours after dose # 2 on 18Feb2021.I had flu like symptoms.; achy legs; achy back; chills; fatigue; Headache; runny nose; mild cough; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (Lot number: EN6200) at single dose for covid-19 immunization on 18Feb2021 (08:15 AM, at left arm). Relevant history included allergies with Sulfa drugs. Relevant concomitant drug was unknown. The patient received the first dose of BNT162B2 (Lot number: EN9625) for covid-19 immunization on 28Jan2021 (08:15 AM, at left arm). The patient did not receive other vaccine in four weeks. No other medications received in two weeks. The patient stated about 15 hours after dose # 2 on 18Feb2021, at 11:30 PM, she started to have flu like symptoms (achy legs and back, chills, and headache which recovered by 7:00 am the following day. Started about 7 am the day following, very runny nose(used 2 boxes of tissue in 24 hours) and had intermittent headache and fatigue. At the reporting time (day 3) and she was still having very runny nose and mild cough. No treatment was received. Outcome of event was resolving. The patient was not infected COVID prior vaccination. The patient did not have COVID test post vaccination.
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| 73 | 2021-03-24 | inability to speak |
I felt paralyzed, unable to move or speak after a nap. It lasted several hrs. and I thought I migh...
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I felt paralyzed, unable to move or speak after a nap. It lasted several hrs. and I thought I might be dehydrated. A friend had to assist me to sit up and drink water. I had confusion and difficulty speaking in complete sentences. No treatment sought. Pt reported this on 3/25/2021 as her response to her first dose, after already having then had her 2nd dose.
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| 73 | 2021-03-24 | inability to speak, seizure, facial paralysis | Seizure, aphasia, facial droop 3 days after receiving vaccination. |
| 73 | 2021-03-24 | cold sweat |
Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling be...
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Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling better by noon. ongoing waves of brain fog, pressure behind my eyes. I seek no treatment, hope it will improve with time. Would like to know if it is advisable to have the second dose. I do not want to repeat the previous experience. Are you able to advise? Thank you
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| 73 | 2021-03-25 | tremor, tingling |
Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness ...
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Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness on her bottom lip to the center of her lip. It spread throughout the entire bottom lip. Then it moved to the left hand corner of her mouth as well, and then moved up to the left side of her face to her eye, and then to the corner of the left hand of her head. This is a tingly pressure, and it then developed into a hard headache concentrated in one spot. She went into heavy sweating. The pharmacist was watching her and came over to her, she was there for about an hour and a half. She had a bottle of water trying to cool off, and her tongue was getting a bad taste in her mouth, and numbness in the back of her tongue. The pharmacist gave her Benadryl to take and she sat there for a while and was starting to feel really shaky, and she thought she would go back to her apartment to get out of being around other people. She was feeling weak to walk, and overwhelmingly tired. Once she did get into her apartment she her taste buds felt dry. After several days of this reaction, little by little it subsided, but the sweating and chills continue even up until today, 3/26/21. She goes to bed dry and wakes up soaked from sweat due to profuse sweating. She has been yawing a lot lately and if she does yawn she immediately has chills. It's been back and forth with the chills/fever. She can be perspiring on one end and the other end cold. She tried to talk to her doctor but told her to seek out UC for her symptoms as he is too busy. There is eye strain that is bothering her which leads her into wanting to sleep and sleeps for extended periods of time and really exhausted. Has also had runny nose, hands and feet swelling. Her right hand is kind of like a tingling/weakness sensation.
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| 73 | 2021-03-25 | feeling hot |
Had a rush of heat inside about around back side at waistline. Lasted during the 15 minute stay aft...
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Had a rush of heat inside about around back side at waistline. Lasted during the 15 minute stay after shot. Reported to nurse, she looked and there was no redness. She had me wait another 15 minutes. Sensation was still there but she had me go ahead and go home. This went away but I still have periodic times of the heat sensation. My doctor wanted me to report before she would pursue.
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| 73 | 2021-03-25 | feeling cold | Patient fainted, coming in and out of consciousness, complained that she feels cold |
| 73 | 2021-03-25 | pain in extremity |
Patient reported arm pain, itchy rash and swelling after receiving the vaccine. It has been 3 days a...
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Patient reported arm pain, itchy rash and swelling after receiving the vaccine. It has been 3 days and she doesn't have any resolution of symptoms.
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| 73 | 2021-03-25 | difficulty speaking |
With both COVID vaccines pt experienced raspy voice, hoarseness, funny feeling in bronchial tubes. ...
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With both COVID vaccines pt experienced raspy voice, hoarseness, funny feeling in bronchial tubes. Pt denies SOB, CP or anaphylaxis. Her symptoms started approximately 1 hour after admin and resolved within 3 hours of onset.
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| 73 | 2021-03-26 | numbness and pain in extremities |
After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 day...
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After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 days went to urgent care checked out OK but symptoms persist to this day. On 3/13 severe dizziness and vomiting and blacking out and went to ER. Admitted overnight. Pulmonologist prescribed course of Prednisone on 3/15 and ending on 3/25. Some relief for chest tightness Neuropathy has gotten steadily worse with inclusion of face and lower leg. On 4th day began some ringing in ears which is to this day louder. Have fatiugue, sleep issues, trouble focusing my brain and eyes. Everything is worse today. Can't hold my head up. Will someone please help me
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| 73 | 2021-03-26 | weakness, tremor |
Heart Attack: taken by ambulance to hospital ER: symptoms were weakness, pounding, racing heart, un...
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Heart Attack: taken by ambulance to hospital ER: symptoms were weakness, pounding, racing heart, uncontrollable shaking
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| 73 | 2021-03-27 | tingling, pain in extremity |
That Thurs evening arm neck hurt...then killer headache. Went to bed fever, body aches joints burned...
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That Thurs evening arm neck hurt...then killer headache. Went to bed fever, body aches joints burned. Sat fever back to normal. Didn't eat just drank water. Sunday skin felt prickly...yep shingles. Took valcyclovor and applied Ravensara.
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| 73 | 2021-03-28 | weakness |
Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high bl...
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Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering. Information on the lot/batch number for first dose has been requested.
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| 73 | 2021-03-30 | bell's palsy |
Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-ye...
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Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.
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| 73 | 2021-03-30 | flushing |
roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaust...
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roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaustion for 36 hours; This is a spontaneous report from a contactable consumer (patient reported herself). A 73-year-old non-pregnant female patient received BNT162B2 (COVID 19, Formulation: Solution for injection, Lot number: EL9269) via an unspecified route of administration on 06Feb2021 11:00 AM at single dose for Covid-19 immunization. The patient's medical history included coronary artery disease (CAD), arthritis and known allergies/allergies. Concomitant medications were not reported. Other medications in two weeks: Yes. Facility type vaccine: facility. On 06Feb2021 11:00 AM, the patient experienced roof of mouth felt numb, heart raced, then felt palpitations, strong headache across eyes and forehead, face flushed and exhaustion for 36 hours. Covid was not tested prior or post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date.
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| 73 | 2021-03-30 | pain in extremity |
sore arm; Left arm achiness; a little light headedness/slight lightheadedness; slight blurred vision...
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sore arm; Left arm achiness; a little light headedness/slight lightheadedness; slight blurred vision/slight blurry/ fuzzy vision; slight headache; This is a spontaneous report from a contactable Consumer. A 73 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN, expiry date: 31May2021), via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient medical history included ongoing Lymphocytosis and the patient is allergic to eggplant, Aspirin and penicillin.The patients concomitant medications were unknown.On 30Jan2021, the patient received the 1st dose of the vaccine and experienced nothing major but a sore arm that resolved, a little light headedness and ever so slight blurred vision that resolved on the night of the shot. she had her first Pfizer shot and she had the usual side effects that evening of a slight headache and feeling achy afterwards. She says after the shot she was fine, but a little bit of lightheadedness and a little bit of fuzzy vision but it was minimal. She says it's like if you're looking in the distance at a stop sign, it was a little fuzzy. These happened last Saturday. These two symptoms were very slight, the lightheadedness was nowhere near passing out and the little bit of blurry vision was ever so slight and gone several hours later. Outcome of event sore arm; Left arm achiness, a little light headedness/slight lightheadedness, slight blurred vision/slight blurry/ fuzzy vision and slight headache was recovered. No follow up attempts are possible. No further information is expected.
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| 73 | 2021-04-01 | facial paralysis, tremor, speech disorder |
Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in ri...
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Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation. Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-04-02 | pain in extremity |
Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my righ...
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Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my right calf; Had difficulty just walking; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in left arm on 12Feb2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart (as reported) and known allergies to penicillin. There concomitant medications were not reported. On 15Feb2021 18:30 the patient experienced two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf, had difficulty just walking. It was reported that two nights after receiving the vaccine, she suffered shortness of breath and pain in her right calf. She tried to relax the next day, but had difficulty just walking. She went to a walk in medical facility. They sent her to the ER. After testing they found that she had two blood clots in her right calf that travelled up to my lungs. The event two blood clots in my right calf that travelled up to my lungs was considered as serious (hospitalization) and other event were considered as serious (hospitalization). The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included blood test on 15Feb2021 with showed two blood clots in my right calf that travelled up to my lungs and sars-cov-2 test with negative results on Feb2021.Therapeutic measures were taken as a result of two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf and had difficulty just walking. AE treatment included blood thinner. The outcome of the events was recovering. No other vaccine was given to patient in four weeks and two weeks. No Covid prior vaccination. If Covid tested post vaccination: Yes. Patient was covid tested post vaccination in Feb2021 with negative results. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Facility type vaccine was Public Health Clinic facility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
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| 73 | 2021-04-06 | numbness and pain in extremities |
Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vo...
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Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vomiting; vision changes; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, glaucoma, Manages cholesterol, controlled high BP and iodine contrast. The patient's concomitant medications were not reported. The patient experienced neuropathy, shortness of breath, chest tightness , ringing in ears, fatigue, brain fog, dizziness, vomiting and vision changes on 10Mar2021 03:00. The patient was hospitalized for all of the events for 2 days on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Mar2021. The patient was not pregnant. Outcome of the events was not recovered.
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| 73 | 2021-04-09 | pain in extremity |
pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoul...
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pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoulder; pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm; tooth ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6198, via an unspecified route of administration administered in right arm (shoulder) on 03Mar2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure abnormal, thyroid problems, fall (fell a couple of years ago), and trouble with her shoulder (prior to getting the vaccine). She reported that she did have some trouble with her shoulder prior to getting the vaccine. She fell a couple of years ago and the doctor's x-rayed it and thought it was pulling away from the bone. They didn't have to do surgery. She was completely over that and it had resolved before getting the vaccine. Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient has no prior vaccinations within 4 weeks. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET) taken for diabetes from an unspecified start date and ongoing (been taking it a long time over 20 years); glipizide taken for diabetes, start and stop date were not reported (been taking it a long time over 20 years); losartan taken for blood pressure from an unspecified start date and ongoing (been on it about 10 years, her blood pressure is in between and it doesn't bother her a lot, it is not really high or low); and thiamazole (METHIMAZOLE) taken for thyroid problem from an unspecified start date and ongoing (been on it about ten years). Patient was calling because she had her first Pfizer shot about three weeks ago. About three days after on 06Mar2021, she developed pain in the right shoulder where she got the shot. It has been bothering her up until this time. She also had a pain over her heart area. The pain over her heart area occurred when she was breathing it. That has gone away. She had her second shot today and she was trying to explain to the doctor what happen to the right shoulder. He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. She clarified Pfizer shot as COVID19 vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm in Mar2021. She got first and second dose. She got the first dose of COVID19 vaccine on 03Mar2021. Pain in the right shoulder: it felt like her toothache has something to do with the pain in the shoulder. The toothache came on a little later (Mar2021) than the pain in the shoulder. The tooth ache is still ongoing, but it has improved. Pain over heart area: It started at the same time as with the pain in the right shoulder. The pain over the heart stopped about a week ago. She thinks she has recovered completely. She didn't have anything done for the heart pain. She got the second dose today, 25Mar2021, lot number: ER8733, Expiry date: unknown. The outcome of the events 'pain over her heart area and pain in the right shoulder travels down the right arm/it goes down the shoulder and down the arm' was recovered, event tooth ache was recovering, and events 'pain in the right shoulder where she got the shot (vaccination site pain) and pain in the right shoulder' was not recovered.
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| 73 | 2021-04-11 | weakness |
increasing body wide weakness 1 day after vaccine, found to be in fulminant renal and hepatic failur...
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increasing body wide weakness 1 day after vaccine, found to be in fulminant renal and hepatic failure with +troponin and rhabdomyolysis with no other preceding symptoms or significant history
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| 73 | 2021-04-12 | breast pain |
3 bouts of ulcerative colitis; her B12 was over 2000; copper was 189.2; Folate 16.8; foamy spit; dry...
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3 bouts of ulcerative colitis; her B12 was over 2000; copper was 189.2; Folate 16.8; foamy spit; dry mouth; Breast pain in the right side; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Solution for injection, Lot number: unknown), via an unspecified route of administration in right shoulder muscle on 05Mar2021 at the age of 73 years old as SINGLE DOSE for COVID-19 immunization. Patient medical history included Hypothyroidism and high blood pressure. Concomitant medications included levothyroxine sodium (SYNTHRIOD), one half of 25 mcg tablet, once a day, taking the medication many years, it's been like 5 years for Hypothyroidism and hydrochlorothiazide 25mg 1 tablet daily for High blood pressure. On 18Mar2021, she had 3 bouts of ulcerative colitis, foamy spit, dry mouth, breast pain in the right side where she got first dose. The patient reported that, she had the Covid vaccine in March of 5th, she has some lab test drawn on 18th and copper level was extremely high and folate level was high too, plus she has been having Phony stiff in my mouth. It was also reported that, her B12 was high also it never been so high it never been 2000 and I haven't been taking b12 from quite a while, she wonders if this was shot related, had dry month and besides that she had three bout of colitis, ulcerative colitis attacks. The colitis, it started than and went through 24th about had 3 bouts of it 3 different days of terrible pain, started probably the 20th. It was also reported that, she is not eating a lot and not taking any supplements, her doctor told her to stop everything so that's what she did, usually she takes supplement. She said she is hesitant about taking the second dose. Caller wanted to know does the vaccine have copper in it and response. The patient supposed to get her 2nd one on Friday. On 18Mar2021, the patient had performed with lab tests and which included vitamin B12: 2000 pg/mL; Copper: 189.2 ug/dL and folate: 16.8 ng/mL. The patient did not take any treatment for events. There was no PQC involved. The outcome of the events was not recovered. Information on Lot/Batch number was requested. cannot be obtained.
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| 73 | 2021-04-12 | paralysis | Paralysis (CMS/HCC) death |
| 73 | 2021-04-16 | one side paralysis |
Patient had a possible stroke, or possible head bleed from her fall yesterday. Documented s/s of CV...
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Patient had a possible stroke, or possible head bleed from her fall yesterday. Documented s/s of CVA prior to immunization. Pt has left-sided lower extremity functional limitations. left arm extremity weakness. left leg extremity weakness. Admitted to hospital from 1/14 - 1/18 Diagnosis CVA
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| 73 | 2021-04-17 | migraine |
Could understand words but could not answer back; Her symptoms came out as if she was having a strok...
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Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
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| 73 | 2021-04-18 | muscle spasms |
wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distress...
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wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distressed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730 and expiration date Jul2021) via unknown route on 01Apr2021at 16:00 at single dose for COVID-19 immunisation. Patient reported that she was allergic to bee stings so her doctor told her she should wait 30 minutes after getting the vaccine to observe for any reaction instead of the 15 minutes. The patient concomitant medications were Zydus, USP 75 mg Venlafaxine HCl (EFFEXOR XR). Patient was fine and left, when she got to her car she took 2 Tylenol and went to the grocery store and did some errands. 4 hours later, patient took 2 more Tylenol. Patient reported that this morning (02Apr2021) she got up from bed to go to the bathroom and noticed that when she wiped herself there was blood on the toilet paper and "quite a bit in my pajamas". Patient reported she was experiencing cramps. Patient believes she's having her period. Patient sounded distressed, reported that she hasn't had a period in years and now she is anxious and scared. Is really scared and wanted so seek medical advice. Unable to contact personal doctor, Declined ISI, cold transferred to PMI due to hold time. Will fax AE for side effects. Patient reported that yesterday she also started a new dose of her Effexor which was increased from 37mg to 75mg which she takes for anxiety and depression, she took the first increased dose yesterday evening and doesn't know if that is what caused this or the Covid shot. Her second dose is scheduled for 29Apr2021. Patient reported that she called her General Practitioner who was not in the office today and her GYN who hasn't yet called her back but she reports that the nurse instructed her to go to the walk in clinic for evaluation, but the caller reports she don't want to go because of the Covid. She spoke with someone before speaking to this agent saying they read her a bunch of information but it was not clear if she spoke with safety or customer service. Obtained the lot number for her first vaccine dose with exp. Patient stated 'I'm a nervous wreck" asking, if the symptom she was experiencing is from her Covid vaccine. Patient asked if her second shot supposed to be more than 21 days from the first. The case was reported as non-serious. Upon callback, she stated she has had a really bad day and spent all afternoon at the walk in clinic. She found out her symptoms were not related to the vaccine and said she could not talk anymore because she was driving. Callback made but caller said she could not talk and did not request a callback. The outcome of the events was unknown. Additional Information is requested.
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| 73 | 2021-04-23 | muscle spasms, tingling |
Muscle spasm; Lump in a small area that she can rub; Tingling in her arm; Itch; Like a tiny pinched ...
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Muscle spasm; Lump in a small area that she can rub; Tingling in her arm; Itch; Like a tiny pinched nerve; feels like something is biting her in an area that stings; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included cataract (pending clarification). The patient's concomitant medications included fluticasone propionate/ salmeterol xinafoate (ADVAIR) and unspecified drops. The patient received the first dose of the COVID-19 vaccine on 21Jan2021 and experienced muscle spasm and a lump in a small area that she can rub out within a couple days on 23Jan2021 (within 2 days of the dose being given); little bit of muscle spasms and a slight lump will come up in that area and she can rub it out. The muscle issue isn't still happening as much. The patient wanted to know if the tingling is a common side effect. In Jan2021, the patient experienced tingling in her arm and asked could that be because the vaccine she received was cold. The patient asked how long the vaccine should sit out at room temperature. In Jan2021, it feels like something is biting her in an area that stings, like a mosquito bite, and nothing is there; like a bite feeling and it will itch in that area and she will think what could have bitten her. The feeling like a bite, it is like a tiny pinched nerve or something like a mosquito bite and she will look but nothing will be there. The feeling will be in like one specific area. It began very close to the muscle thing around 2 to 3 days after the vaccine (Jan2021). It happens about once per day. It might skip a day here or there but pretty much its once per day. It is about every day or every day and a half or so. The patient was in a place that was below zero. It was mostly her legs but last night it was in her arms. The patient was scheduled to have the second dose tomorrow (16Feb2021) and she is concerned. The patient had cataract surgery last week, so she had to get her purse she also has her drops in there. That is why she did not get the second dose exactly 3 weeks because she had surgery. The patient kept thinking what that weird thing was, it is like a no-see-um bite. The patient called her primary care about it and her recommendation was to get the shot anyway and let them know. It was fairly mild, and she was just curious. The outcome of "Lump in a small area that she can rub", "Tingling in her arm", and "Itch" was unknown. The patient was recovering from "Muscle spasm". The patient had not recovered from the remaining event.
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| 73 | 2021-04-24 | pain in extremity |
Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mou...
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Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
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| 73 | 2021-04-24 | weakness |
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; ...
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Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins. The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
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| 73 | 2021-04-27 | pain in extremity |
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration (injection), administered in the right arm on 12Feb2021 at 13:00 (batch/lot number: EL9267) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 1991 and ongoing (diagnosed 30 years ago; doctor said that he didn't know if she has RA because she's taken all of those infusions and it may just be severe osteoarthritis), ongoing thyroid (disorder), thyroid was removed, knee replacement left leg from 2020 (she had knee replacement last year on her left knee), Achilles tendon tear - reported that she had to have surgery last to repair her right Achilles tendon as it tore, cholesterol (abnormal) from 1991 and ongoing (diagnosed with cholesterol problems 30 years ago), ongoing depression (diagnosed with depression a couple years ago), ongoing sleep problems (experienced sleep problems for a long time), blood pressure (abnormal) from 2013 and ongoing (diagnosed with blood pressure problems 8 years ago), physical therapy, lymphedema, and unable to recall exact dates. There was no family medical history. No prior vaccinations (within 4 weeks). Concomitant medications included amitriptyline taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); folic acid taken for arthritis from an unspecified start date and ongoing (she has been taking this medication for years and years); levothyroxine taken for thyroid, start and stop date were not reported (she has been taking this medication for years and years); chlordiazepoxide (LIBRIUM) taken for sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); losartan taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); meloxicam taken for arthritis from an unspecified start date and ongoing (began taking for 10 or 15 years after switching from celecoxib); metoprolol taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); omeprazole taken for stomach from an unspecified start date and ongoing (helps her stomach with all of the medications she has to take); pravastatin taken for cholesterol from an unspecified start date and ongoing (she has been taking this medication for years and years); desvenlafaxine succinate (PRISTIQ) taken for depression from an unspecified start date and ongoing (she started taking over a year ago, a year and a half or maybe two years ago); levothyroxine sodium (SYNTHROID) taken since thyroid was removed from an unspecified start date and ongoing (she has been taking since 15 years ago, for a long time); temazepam taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); cholecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (she has been taking this medication for years and years). The patient previously took BNT162B2 first dose on 21Jan2021 via injection in the right arm (lot number: EL3047 or EL3247; expiration date unknown) for COVID-19 immunization; and celecoxib (CELEBREX). The patient experienced extensive deep vein thrombosis on 06Apr2021; leg pain and feet swollen/ leg was like a balloon/ leg started to swell on 05Apr2021; throat hurts and tired on an unspecified date. The patient was calling about the Pfizer Covid-19 vaccine. She reported that she and her husband received both doses of the Pfizer Covid-19 vaccine. She received her first dose of the Covid-19 vaccine on 21Jan2021 and her second dose on 12Feb2021. She reported that she has had no complications before such as blood clots or problems with her blood or anything. She reported that on Monday, 05Apr2021, her leg started to swell. She reported that on the following day, 06Apr2021, her leg was so swollen that she couldn't put it down. She reported that she went to the emergency room on 06Apr2021 and was found to have an extremely extensive deep vein thrombosis. She reported that she was calling to complete a safety report. She stated that she doesn't want a deep vein thrombosis to happen to anyone else if her thrombus was from the Covid-19 vaccine. She reported that she and her husband thought they were so lucky as they had no side effects whatsoever following the Covid-19 vaccine doses. She reported that she was not saying that the deep vein thrombosis was from the Covid-19 vaccine but she has never had any blood or clotting problems in her life. Throat hurts: She reported that she thinks that when she was intubated, that whoever intubated her caught her tongue and cut it. She reported that she and her son and husband had been seeing news stories about the (Company name) vaccine. She reported that she has friends that were waiting for the (Company name) vaccine. She reported that her son wanted to send a text message so that others could be aware of the problems they might have. Leg pain: She reported that she went to the dentist on 05Apr2021 and was fine. She reported that when she got home from the dentist, her husband asked if she wanted to the take dog for walk. She reported that she put a leash on her dog and walked to the end of her driveway and said to her husband that she couldn't walk because her leg hurt so much. She reported that she had 2 surgeries last year, a knee replacement in her left leg and an Achilles tendon repair in her right leg. She reported that when she was released from physical therapy that the therapist told the caller that she might have lymphedema. She reported that the physical therapist directed her to go to a clinic that had no doctor where the clinic staff wanted her to buy a (dollar)10,000 piece of equipment to pump up her legs in the morning and at night. She reported that she came home from the clinic and called the podiatrist that repaired her Achilles tendon. She reported that she went to see the podiatrist that day and that the podiatrist ordered an ultrasound. She reported that a vascular surgeon called her regarding the ultrasound and stated that there was nothing wrong with the veins in her legs. She reported that the surgeon stated that they could tell there was nothing wrong with the her because her feet weren't swollen and instructed her to follow up in 9 months. She reported that on 05Apr2021, she went back into her house after experiencing the leg pain. She reported that her feet were not swollen and she was not that concerned. She reported that she thought maybe she was just tired and laid down. She reported that when she woke up the next morning, 06Apr2021, that her feet were like balloons. She reported that her son called a friend of his who was an orthopod. She reported that her son's friend instructed her son to take her to the emergency room, recommending that they bypass a certain hospital. She reported that she went to the emergency room on 06Apr2021. She reported that the emergency room staff did an ultrasound as soon as the caller arrived. She reported that the emergency room staff called the vascular surgeon. She reported that the vascular surgeon stated that if he had been in the caller's hospital room 5 minutes earlier that the would have done the surgery then, but that he had to lay her on her stomach to perform the surgery and she had eaten some cookies and drank diet soda. She reported that on the following day, 07Apr2021, the vascular surgeon put a scope in her vein and pulled out the clot. She reported that the physician was extremely concerned because the clots were very extensive. Leg pain: She reported that the leg pain was still ongoing. She reported that it hurts when she walks. She reported that she doesn't know if the leg pain has gotten worse. She reported that her leg pain on 06Apr2021 was excruciating and off the charts. Feet swollen: She reported that the swelling in her feet has maybe gotten slightly better. She reported that her feet were wrapped tightly with ace bandages. Leg swollen like a balloon: She reported that her leg was still swollen but it's gotten better, maybe about 90%. Extensive deep vein thrombosis: She reported that the deep vein thrombosis was removed on 07Apr2021 from her left leg. She reported that she was at end of her life and she had trips planned. She reported that she had a trip planned recently to go to Las Vegas with her daughter. She reported that her daughter was not able to take the trip, and stated she didn't know what would have happened if she had experienced the blood clot while in Las Vegas. She reported that she received both doses of the Covid-19 vaccine in her right arm, as she was in the car and her husband was driving. First dose: Date: 21Jan2021; Lot Number: She reported the lot number as EL3047, then stated that the handwriting was hard to read and that the lot number was either EL3247 or EL3047. She stated when reporting on her history that she has no concept of time and was unable to recall exact dates. She reported that while in the emergency room and during admission, the hospital staff did labs, but she has no idea what the results were. Vaccination facility type was drive through clinic at (clinic name). Vaccine administered at military facility: No. The adverse events leg pain, swelling in feet and leg, extensive deep vein thrombosis required a visit to the emergency room. Did not require a visit to the physician's office. The patient was hospitalized for 6 days for extensive deep vein thrombosis from 06Apr2021 to 12Apr2021. The patient underwent lab tests and procedures which included CT scan of chest: normal on an unspecified date, ultrasound: there was nothing wrong with the veins in her legs on an unspecified date, ultrasound: unknown results on an unspecified date. The outcome was not recovered for the event leg pain; recovering for the event feet swollen/ leg was like a balloon/ leg started to swell; and unknown for the rest of the events.; Sender's Comments: Reported events are assessed as intercurrent medical conditions probably associated to patients underlying conditions and are therefore unlikely related to BNT162B2.
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| 73 | 2021-04-27 | burning sensation, pain in extremity |
she have her arm completely swollen to the elbow and it is red with a circle around the injection si...
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she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis; Still having problems with left arm it still burns, itches, and still has a throbbing pain; Still having problems with left arm it still burns, itches, and still has a throbbing pain; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number), via an unspecified route of administration, on 09Apr2021 (at the age of 73 years-old) as a single dose for COVID-19 immunization. Historical vaccine information included bnt162b2 (COMIRNATY), 1st dose on an unspecified date and no adverse reaction. The medical history included: acid reflux. Concomitant medications were not reported. She says that she is a healthy person and does exercise, has no weight problems, nothing but acid reflux. The patient reported that she got the second on Friday at 1 pm and now she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis and she is not happy about this. Her left arm was on fire, burned, very swollen from the site all the way down to the elbow. That went away, the swelling finally started to go down Tuesday of last week but she is still having problems with left arm it still burns, itches, and still has a throbbing pain. She has been in the ER twice already and they told her that if the circle around the injection site gets bigger she would need an IV. She has been to the ER 3 days later twice at two different locations. Caller states she is still having difficulty after getting her second Pfizer shot. She contacted her doctor to let them know because she wants them to document everything. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 73 | 2021-04-28 | pain in extremity, cold sweat |
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ...
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didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-05-03 | bell's palsy, numbness |
I got the first Covid shot on April 13, 2021. The next day in the afternoon I noticed that the righ...
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I got the first Covid shot on April 13, 2021. The next day in the afternoon I noticed that the right side of my face was sort of sagging and I has having a hard time drinking without it spilling out of the right side of my mouth. I called my doctor, but it was around 4:30 PM, 4/14/21. The next morning I got a call back from her office around 10:30 AM, 4/15/21 and told them what was happening, I had Bell's Palsy about 20 years ago and this seemed to be the same thing. She had me go to the ER just to be sure I wasn't having a stroke. I got to the hospital around noon and they saw me right away. the physician who saw me and diagnosed Bell's Palsy. I got two prescriptions, one for Prednisone and one for Acyclovir. I seemed to shake off the numbness in about 4 or 5 days. I saw my own Dr. on 5/3/21 for ER followup.
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| 73 | 2021-05-04 | pain in extremity |
Headache; extreme exhaustion; Felt like she was freezing and had the chills; arm is still sore; This...
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Headache; extreme exhaustion; Felt like she was freezing and had the chills; arm is still sore; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9264)intramuscularly into the left arm on 05Feb2021 17:00 (at the age of 73-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said that she had some adverse events after receiving the vaccine. On 05Feb2021, the patient stated that her arm was still sore. The hcp that gave her the injection was not gentle. She said that she noticed the soreness in her arm on Friday night. Laying in bed if she laid on that side, she noticed that it was sore and not up to par. She said that she did not expect it to last this long. On 06Feb2021, the patient reported of extreme exhaustion after receiving the injection which was like having Covid all over again and felt like she was freezing and had chills both of which resolved on 07Feb2021 after a good nights sleep at about 10:00 to 12:00. She had 3 weeks of it with Covid though. She said that it started about 18 hours after she had the shot. She stated that she felt fine when she woke up, but after she started doing some stuff, she just could not function. On 07Feb2021, she had a bit of a headache which recovered on the same day. She said that she took a couple of Tylenol and it seemed to resolve. She had Covid over the holidays and that her brain does not always match her tongue when she was trying to explain her symptoms. She stated that she was not looking forward to the second vaccine because everyone she spoke with said that the side effects are worse with the second vaccine than they are with the first. No further details provided. No prior vaccinations within four weeks nor any relevant tests done. Outcome for exhaustion, headache and chills was recovered/resolved whereas it was recovering/resolving for pain in arm.
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| 73 | 2021-05-04 | breast pain, tingling |
one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash;...
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one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash; tingling of the left breast; Foggy different feeling; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of BNT162B2 (Pfizer COVID19, Solution for injection, Lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 15:00 for Covid-19 immunisation. The patients medical history included Breast cancer, thyroid cancer, blood pressure and palpitations. The patient had allergic to Z-pak. The concomitant medication includes Synthroid 150mcg 1 tablet by mouth once a day for thyroid cancer. Relevant Family medical history included Shingles shot, she took one a long time ago, like 10 years ago, it gave her ringing in the ear. She had no other vaccines on the same day on in the 4 weeks prior to the first dose. On 12Feb2021, the patient experienced Foggy different feeling, on 13Feb2021 at 16:00, tingling of the left breast, on 14Feb2021 experienced Left breast hurt, heart palpitations and localized rash described as red with white lumps. She had no ER visit. The outcome of the event foggy different feeling, left breast hurt, and white lumps was recovered, whereas of red rash and heart palpitations it was recovering and for tingling of the left breast it was recovered with sequelae. The patient underwent lab test which included blood work whose results were unknown and TSH with results 0.57. She wanted to know if those AEs are from the vaccine and if she is ok to get the second shot. She felt lightheaded for 20 minutes, in the left breast is where she had cancer and it was in situ in the duct, it had not spread for which she received 8 weeks of radiation. She went to bed and noticed that her breast was hurting in the night, but she was too tired to get up at that point, when woke up and took a shower she lifted the left breast and saw a massive, bigger than pancake, rash. It was on the bottom of the breast and it ran down to the stomach, it also had white lumps on it, this just frightened her. There was severe redness before, but that has started to fade, it was still dark brown right now, like she can see outline, but it was going away. Before when there was redness, she could press the spot and it would turn white, it would be red again. When read the instruction that came it says there could be a side effect of a rash, but it would be all over the body not localized. She does not know if the vaccine was responsible for it. Then just quickly she started having heart palpitations on Sunday, just a few, but on Monday it was like a 100 of them. She called doctor, at this point that she also has a history of thyroid cancer in 1982, they removed 2/3rds of her thyroid and since then she has been on Synthroid. When her thyroid was not working properly, she had a TSH done. She got lab work done just to see if it was the thyroid. The doctor said it could be from the shot. The Heart Palpitations were fading, she stopped taking Synthroid for 1 day and it went from 100 palpitations to 50, to like 6-7 now. The heart palpitations were going away and that was after stopping the Synthroid for 1 day. The Light headedness only lasted for 20 minutes but started 5 minutes after getting the shot. She clarified that it was not lightheadedness she means to say that she was a little foggy and had a different feeling. The tingling in the Left Breast began, it was for a couple hours, she thought it was different. Normally she doesn't have that. She has had 6 breast operations, so she has very little feeling in that breast normally. Her left breast began to hurt when she was sleeping, she was too tired to get up and look, she rolled over felt something was wrong. This was at 2-3AM on and it subsided when she took shower and patted all around, she dried it and kept an eye on it, the pain started to go away easily. She did notice that she started to feel a little bit of an itch, but that went away quickly too. She had the rash and lumps, it was during the shower she lifted the breast and saw it. She has a picture to provide. It is Not ongoing, it has started to fade, it is still dark reddish brown, but she can tell it was going away. The heart palpitations started late at 4 or 5 in the evening, she has not had that for years. She knows at one-point TSH was high, but they like to keep it low like this in which the 1/3 of thyroid stays dormant, this is intentional because if it gets too high.
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| 73 | 2021-05-04 | burning sensation |
ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, bur...
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ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809 and Expiration date was not reported), via unspecified route in left arm on 09Feb2021at single dose for COVID-19 immunization. Medical history included diabetes and overweight. Patient had an allergic reaction to medication. Clarified products as Bactrim and codeine. With Bactrim she had hives all over and went to ER. codeine made her do the exact same thing as she was now (stinging, burning and itching) and hadn't taken codeine or Bactrim for several years. She confirmed that she had no ndc/lot/exp for either codeine or Bactrim. The patient's concomitant medications were not reported (She takes so many medications). On 09Feb2021, four hours after the covid-19 vaccine, the patient experienced ongoing stinging, burning, and itching sensation on her scalp, face, and back. She states there is no visible rash, but these symptoms are consistent with her reaction to codeine. Have these symptoms been reported. Should she get her second dose that was due on 02Mar2021. It has been a full week. She called her doctor and the nurse asked him. Doctor didn't know if that was a listed side effect and should she get her second shot. Has been taking Benadryl (Wal-dryl Allergy HCi-25mg antihistamine, Exp: Jun2023, Formulation: 25mg capsules, provided: ORG11719008, 50844 and P120784), but that is not helping. Sometimes after taking Benadryl, it's better, but sometimes it will hit real hard again. Does not see very well. only took one capsule and tried not to take it over twice a day. She takes so many medications. Doesn't know what will mix with what. Therapeutic measures were taken as a result of adverse event. The outcome of the events was not recovered.
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| 73 | 2021-05-09 | seizure |
This 73 year old female received the Covid shot on 3/2/21 and went to the ED and admitted on 3/...
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This 73 year old female received the Covid shot on 3/2/21 and went to the ED and admitted on 3/25/21 with the following diagnoses listed below. R56.9 - Seizure R56.9 - Unspecified convulsions N17.9 - Acute kidney failure, unspecified
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| 73 | 2021-05-11 | unresponsive to stimuli, weakness, inability to speak |
Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inab...
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Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inability to communicate- both expressive and receptive, moaning and complete loss of awareness. The initial episode lasted approximately 4 hours. These episodes repeated for the next 3 days. She was taken to the Emergency Room by ambulance 3 days after the vaccine and a workup was completed. It was negative at the time of exam. She did have a mild anemia, but CT and laboratory work were otherwise negative. She had recovered strength and her memory. Later that evening she was again unresponsive except to painful stimuli and was like that over night. She was fatigued but was repulsive the next day. She never gained her full strength back. Over the next 4 weeks, she had progressively more of the periods of unresponsiveness and amnesia that stayed progressively longer and recovery was even less in-between the periods of unresponsiveness. She was placed on Hospice Care and succumbed on March 9, 2021, 1 month after her first vaccine.
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| 74 | 2021-01-05 | pain in extremity |
Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptom...
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Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs. Headache & sore arm lingering on 1/6/21.
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| 74 | 2021-01-11 | pain in extremity |
Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable cons...
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Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
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| 74 | 2021-01-12 | pain in extremity |
Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm emp...
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Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm employee states that Left arm started aching. Around midnight, employee states that right elbow began to ache as noticed redness and swelling approximately 2-3 inches below injection site. States swelling and redness increased over the course of two days. Friday, the swelling and redness began to improve.
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| 74 | 2021-01-12 | flushing | felt flush. Symptoms resolved prior to leaving facility |
| 74 | 2021-01-13 | weakness |
very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site;...
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very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy. The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
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| 74 | 2021-01-14 | pain in extremity, feeling of body temperature change |
fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; fel...
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fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; felt 'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention. Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt 'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt 'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
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| 74 | 2021-01-15 | pain in extremity | Sore arm that day (1/14) which is normal. Brain fog the following morning for 4 to 6 hours. |
| 74 | 2021-01-20 | bell's palsy | Bells Palsy |
| 74 | 2021-01-20 | bell's palsy | Bells Palsy diagnosed by ER 1-15-2021. treated with Prednisone and Acyclovir. |
| 74 | 2021-01-20 | feeling cold |
Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really ...
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Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really cold with chills and a headache. It lasted 24 hours.
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| 74 | 2021-01-21 | burning sensation |
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my...
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As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
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| 74 | 2021-01-23 | pain in extremity |
On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evenin...
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On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evening I experienced a pain on my right side that went along the outside starting at the base of my little toe and continuing to the heel of my foot and from there going right on up the outside of my right leg to the base of my hip. At this point I laid down which made the pain a little better. I tried rubbing the area but that didn"t help much. I did take one advil an hour before bedtime but the moderate pain stayed the same. At midnight I went to bed and was able to sleep. By morning I was fine.
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| 74 | 2021-01-23 | pain in extremity, discomfort |
Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ac...
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Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ached, had chills, and could not get comfortable in bed. Once up at 7 AM took two Advil 200mg with relief
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| 74 | 2021-01-24 | tremor |
Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP:...
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Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP: 160/60, HR: 70, RR: 24-28, O2 sats: 98%. No other symptoms noted. Pt. assessed local EMS. Declines going to emergency room today. Pt. plans to go to urgent care or call PCP.
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| 74 | 2021-01-24 | tremor |
Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. wa...
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Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. was immediately assessed by Physician. Also assessed by local EMS. BP: 160/60, HR: 70, RR: 24-28, O2 sates: 98%. Pt. declines to be transported to the emergency room. Plans to make appt. with PCP.
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| 74 | 2021-01-24 | facial pain, weakness, pain in extremity |
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ...
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Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
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| 74 | 2021-01-24 | weakness | Lack of energy Feel exhausted |
| 74 | 2021-01-24 | numbness |
Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checke...
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Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checked and 1 25mg of Benadryl given PO, Pt rested approx. 2 hours before she felt comfortable to leave
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| 74 | 2021-01-26 | flushing |
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccine patient felt flushed. Vital signs...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccine patient felt flushed. Vital signs taken and all within normal ranges. Patient observed for thirty minutes after vaccination and at end of observation period stated they felt a sensation of throat closing. No rash, shortness of breath, or uticaria noted. Patient took one dose of diphenhydramine 25 mg by mouth and symptoms resolved. Repeat vital signs remained within normal ranges and no new symptoms developed. Patient discharged from vaccination clinic to home stable.
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| 74 | 2021-01-27 | tingling |
Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic react...
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Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic reaction and she was released the same day.
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| 74 | 2021-01-27 | muscle spasms, weakness |
Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, ...
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Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, not able to do much No appetite Urine strong odor, different color, and frequent Cramping in hands and feey
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| 74 | 2021-01-27 | breast pain, pain in extremity |
tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, up...
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tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
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| 74 | 2021-01-28 | feeling hot |
15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the...
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15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the right side of my throat. I was monitored in the ER, seen by the doctor and given 25 mg of Benadryl. My BP was high. I was discharged after approximately an hour and a half after incident. THESE WERE MILD SYMPTOMS. I was told to take Benadryl for the next 48 hours, which I did.
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| 74 | 2021-01-28 | pain in extremity |
Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours aft...
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Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours after vaccination Symptoms still present, but beginning to improve after 48 hours
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| 74 | 2021-01-28 | pain in extremity, discomfort |
it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; ...
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it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
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| 74 | 2021-01-30 | burning sensation |
15 minutes after injection, I had a strong metallic taste in my mouth. One hour to 1.5 hours after ...
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15 minutes after injection, I had a strong metallic taste in my mouth. One hour to 1.5 hours after the injection, my tongue felt scalded . My tongue has an obvious red ring which continues to have a burning sensation. Day 3 and it is somewhat less sensitive but continues to burn.
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| 74 | 2021-01-30 | pain in extremity |
Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body ac...
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Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body aches and chills. Left arm sore for three days.
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| 74 | 2021-02-01 | weakness | Altered mental status; Chest pain; Elevated troponin; Generalized weakness |
| 74 | 2021-02-01 | weakness | Cant get her breath, intensely weak, chills. |
| 74 | 2021-02-01 | inability to speak |
Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore th...
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Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore throat, nausea, vomiting, diarrhea, altered taste Also complaint of intermittent acute shortness of breath and cough
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| 74 | 2021-02-01 | weakness |
No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling u...
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No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report. There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment. Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
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| 74 | 2021-02-01 | weakness | Weakness, Tiredness |
| 74 | 2021-02-02 | numbness |
1/28/2021 received her 1st dose of Pfizer COVID-19 vaccine yesterday and about an hour later starte...
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1/28/2021 received her 1st dose of Pfizer COVID-19 vaccine yesterday and about an hour later started experiencing numbness of her nose, mouth and tongue, she also felt eye pressure and thought she was going to have a migraine but never got a migraine. Now (about 19 hours later) the numbness is about 75% resolved. not too concerned about it and would like to receive her 2nd dose of vaccine. So far she has not had any other notable adverse reaction. will call me next week to follow up. 2/3/2021--called and reports that still experiencing numbness of her nose, mouth and tongue but it has resolved a little
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| 74 | 2021-02-02 | flushing |
Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patien...
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Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patient. BP 154/85 (baseline, 120's/60's), pulse 64. Given juice, rested, felt better after 15 minutes.
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| 74 | 2021-02-02 | weakness | Nausea, vomiting, Temp over 100, extremely weak, head ache |
| 74 | 2021-02-02 | pain in extremity |
The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept...
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The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept fitfully. Felt tired. Fever continued until 5 pm the next day (Saturday). Didn?t eat much. Fever broke late afternoon on 1/30 and I felt better. Slept better. But was very, very tired the next two days (1/31 and 2/1). Felt normal the 4th day, 2/2. My first shot was on 1/12/21 and I had no reaction other than a sore arm. For 24 hours.
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| 74 | 2021-02-02 | weakness |
Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. State...
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Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. Stated could not get out of bed, could not walk, has severe weakness. flank pain, nausea, headache, fever, and chills
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| 74 | 2021-02-03 | pain in extremity |
Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This i...
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Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BTN162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E13246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the public health clinic/veterans administration facility. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Jan2021, the patient experienced pain in left arm and at injection site and large bruise, which were assessed as non-serious. One week after the injection, she still had pain in left arm and at injection site and also a large bruise. The patient did not receive any treatment for the adverse events. The patient was not recovered from all the events.
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| 74 | 2021-02-03 | feeling cold |
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; ...
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she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
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| 74 | 2021-02-04 | feeling cold, pain in extremity |
First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : ...
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First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : pain in the arm began the day of vaccination, second day at noon began chills, fatigue, joints pain and and fever at around 4 pm , highest reading 100.4 Third day feeling good for
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| 74 | 2021-02-04 | feeling cold |
Patient felt cold, some shortness of breath right after vaccine. Experienced anxiety too. Given wate...
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Patient felt cold, some shortness of breath right after vaccine. Experienced anxiety too. Given water and apple juice - felt better and was discharged to home. Vitals: 168/96, 162/86 (pulse 68). O2 sat 100%.
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| 74 | 2021-02-04 | tingling |
after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experie...
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after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experienced some tingling in the face, and head .
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| 74 | 2021-02-04 | pain in extremity |
received BNT162B2/ medical history included ongoing breast cancer; received BNT162B2/ medical histor...
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received BNT162B2/ medical history included ongoing breast cancer; received BNT162B2/ medical history included ongoing breast cancer; sore arm; This is a spontaneous report from a contactable healthcare professional. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included ongoing breast cancer. Concomitant medications were not reported. The patient previously took palbociclib (IBRANCE) in Oct2019, Sep2020, then in Dec2020 for breast cancer and experienced diarrhea, mouth sensitivity, lowered white blood, tired, hair loss, fluctuating blood sugars with insulin adjustment. On an unspecified date in Jan2021, the patient experienced sore arm. The outcome of the event was unknown. Information on Lot/Batch has been requested.
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| 74 | 2021-02-05 | pain in extremity |
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site p...
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About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
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| 74 | 2021-02-05 | pain in extremity | Unable to lift arm and soreness. Flu like symptoms - muscle aches, chills, headache |
| 74 | 2021-02-06 | tingling, numbness |
30 minutes after injection started noticing numbness and tingling in left arm. It also went to left ...
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30 minutes after injection started noticing numbness and tingling in left arm. It also went to left side of my face. Felt like Novocain after a dentist visit. Also had high blood pressure. 232/100
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| 74 | 2021-02-06 | pain in extremity |
From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and s...
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From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and swollen. Patient reported pain as well as itching in the swollen part. Arm was also bruised the size of a half dollar at the injection site. Dr. diagnosed her with cellulitis after immunization and prescribed her amoxicillin 875mg twice daily for 10 days.
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| 74 | 2021-02-07 | pain in extremity |
At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade...
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At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade fever (99.4 when normal temperature is in low 97s). Also had a fairly bad headache, a fast heartbeat of up to 111, hips and legs ached, and felt a bit nauseated. At about 9 am took 1 extra-strenghth Tylenol, with little help. At 1 pm took 2nd Tylenol and all symptoms were pretty much gone by 3 pm in the afternoon.
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| 74 | 2021-02-07 | tremor |
Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning...
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Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 74 | 2021-02-07 | feeling hot |
Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Ra...
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Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Rash is red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. The patient had a regular routine appointment to the HCP on Monday. The patient medical history and concomitant medications were not reported. The patient noticed every day she had a red rash that was about the size of her palm. Rash itches a lot. Rash was red and warm to the touch. The patient wanted to know should she be concerned and what to do to get rid of it or should she ignore it. She did not think she was going to die, it just kept continuing. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 74 | 2021-02-08 | weakness |
Weakness, slight swelling of upper lip and construction of throat. Weakness after 15 minutes, swell...
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Weakness, slight swelling of upper lip and construction of throat. Weakness after 15 minutes, swelling and construction after 40 minutes, on drive home. Went to ER but swelling and construction better by the time I saw doctor. Monitored for about an hour and released. Weakness on and off for several days after. Followed up with primary care doctor and referred to an allergist. Waiting for appointment.
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| 74 | 2021-02-08 | pain in extremity |
about 2 hours after shot my throat felt like it was closing and had a hard time swallowing. lasted ...
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about 2 hours after shot my throat felt like it was closing and had a hard time swallowing. lasted only until the next day. Arm was sore.
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| 74 | 2021-02-09 | pain in extremity |
Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore o...
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Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore on the arm; This is a spontaneous report from a contactable consumer reporting for self. This 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux, stomach relaxer, IBS (irritable bowel syndrome). Concomitant medications included hyoscyamine sulfate for stomach relaxer, omeprazole (PRILOSEC), Vitamin D2, omeprazole for acid reflux. On 23Jan2021, the patient experienced heart beat was high, she was having heart beat was fast and usually it's low, she just feel weird, and also experienced sore on the arm. No treatment received. Lab data included Height: 5ft 5 inches and weight: 140 pounds on unspecified date. The outcome of events was not recovered. Information about lot/batch number has been requested.
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| 74 | 2021-02-10 | burning sensation | I already did. Face itching/burning and nausea I had no red face and no discernible hives or rash. |
| 74 | 2021-02-10 | breast pain |
she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to...
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she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
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| 74 | 2021-02-15 | burning sensation |
About 15 minutes after vaccination, patient began to experience acute pyrexia and nausea. No vomiti...
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About 15 minutes after vaccination, patient began to experience acute pyrexia and nausea. No vomiting. No syncope. Vital signs within normal limits. Borderline tachy. No hypertension, but some shortness of breath and some lightheadedness.. After 1st vaccination , developed body aches and wrist burning on 2nd day. Taken to ED where BP 129/77, HR 80, O2 sat 97%. EKG showed NSR. Symptoms resolved on own.
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| 74 | 2021-02-15 | weakness | Vomiting, weakness, difficulty walking, lasted 24 hours. Passed after sleeping 12-14 hours |
| 74 | 2021-02-17 | weakness, tremor |
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid...
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Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
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| 74 | 2021-02-18 | hot flush, tremor |
Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p. They incl...
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Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p. They included flushing & face really hot & much higher than normal BP. My BP, usually low, 95/67 pulse 61 that morning rose precipitately to 142 in the parking lot via a nurse who tested me. It subsided to 125 within 30 mins. BUT the next morning, W the 17th, it again rose precipitately from 99/65 pulse 74 at 9am to 141/88 pulse dropped to 66, at 10a, it was 150/88 pulse was 73, at 10.30a it was 156/93 pulse 80 and I called the nurse. Again BP rose to 160/84. I tested my right arm where I rec.d the shot, it was still sore. I suggested going to Urgent Care, the nurse advised the ER. I went to ER & by then my BP lowered to 140 & within an hour I left. I notified my doctor bvia a voice mail to her PA and an email today. Im feeling fine today Feb. 19, 2021 & felt fine yesterday Thursday, Feb 18, 2021. With the unusually high BP I felt shaky. This high of a BP is something Ive never experienced before in my life. It was frightening. My only other near death experience was in 1970 at a Hospital getting a broken tooth repaired bc of a car accident. They gave me an injection of Demerol & I immediately went into shock, perhaps anaphylactic, was given Epinephrine I believe & survived the ordeal & he was able to repair the cracked tooth. I was advised to never have Demerol again. It is such a vivid memory I checked with my doctor prior as I was very concerned about the PEG in the Demerol injection & also in the Pfizer vaccine. She advised that I was at a very low risk for adverse reactions from the Pfizer shot. I preferred Moderna after reading it had 1/2 of the Pfizer adverse reactions reported. I was not so lucky.
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| 74 | 2021-02-18 | bell's palsy |
Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale...
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Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale 3-4) Day 2: pain on left side of head and neck intensifies to an 8-9 (treatment: ibuprofen), loss of mobility in face. (PCP emailed with no immediate response) Day 3: full loss of mobility and control on entire left side of face. Emergency room visit diagnosis: Bell's Palsy. Head neck pain persist (no more ibuprofen taken because of stomach pain) ER doctor prescribes 5 day course of Prednisone. Day 4-7: Bell's Palsy symptoms persist unchanged. (Treatment: Acupuncture, 2 visits) Pain on left side of head neck persist at a pain scale of 2-3.
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| 74 | 2021-02-18 | inability to speak, feeling cold, unresponsive to stimuli |
PHN called to 15 minute observation post-immunization by Nurse and Nurse who were with px upon PHN a...
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PHN called to 15 minute observation post-immunization by Nurse and Nurse who were with px upon PHN arrival at 9:50am. Px found to be cool to the touch, crying yet unresponsive; px was unable to verbalize or open her eyes. Respirations were even and non-laborious, rise and fall of chest was visible. VItals monitor brought to scene, Fireman/Paramedic called to scene and 911 called. BP: 161/111, SpO2:95% RA, HR: 80. Husband brought to scene to provide medical Hx information. Hx of High Blood Pressure confirmed with husband, Hx of Diabetes denied by husband. EMS Arrived at 9:56am, blood glucose checked and recorded at 199. PHN rechecked vitals at 09:57am , BP: 143/89, HR:81, SpO2: 95%. EMS advised px received first dose of Pfizer immunization at 9:36am. Px taken to Hospital for further medical work up at 10:08am via ambulance.
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| 74 | 2021-02-18 | pain in extremity |
Sore arm has persisted for three weeks. Had second shot on 2/18/21 which I felt slightly activated t...
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Sore arm has persisted for three weeks. Had second shot on 2/18/21 which I felt slightly activated the pain
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| 74 | 2021-02-21 | feeling cold |
Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then co...
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Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain
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| 74 | 2021-02-21 | seizure | Had seizure 2/5/21 . Does have dx of seizures disorder |
| 74 | 2021-02-22 | weakness |
Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehic...
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Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehicle was feeling short of breath. Rapid response team from hospital came out and transported her to the emergency room. Most current nursing note as of 20 minutes ago, "pt complains of chest pains sob difficulty swallowing and weakness. pt is AA+Ox 4 and has a room air sat of 98% rr of 22, hr of 71."
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| 74 | 2021-02-23 | flushing |
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle...
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12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
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| 74 | 2021-02-23 | weakness |
Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer...
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Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer her to the hospital that can actually perform the surgery she needs; became very weak and didn't tell anyone/too weak to get up; mother was swollen from head to toe with edema; mother was swollen from head to toe with edema; fell using her walker on Wednesday/fell again; Laceration of face; having issues with her kidneys and has progressively declined since; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history using her walker. Concomitant medications were not reported. The consumer reported that her mother had the COVID-19 Vaccine on 21Jan2021. She was now hospitalized and was due to have the second vaccine on 11Feb2021 and stated that her mother was completely unstable for the second vaccine. After receiving the COVID-19 vaccine, medically, she seemed fine. Then, she progressively has gotten worse. First EMS was called. This was about less than a week later after receiving the vaccine. Then, she was admitted into the hospital with a kidney infection and she has progressively declined. She has no idea if it was related to the COVID-19 vaccine or not. She initially called regarding the second COVID-19 vaccine. She didn't know what would happen if her mother didn't show up for her second vaccine. She didn't know if she would get on the "never going to get the vaccine" list or what as her mother was just so unstable. On an unspecified date, her blood pressure was so low right now they can't even transfer her to the hospital that can perform the surgery she needs. The reporter stated that she has no idea if this was COVID related or what. She began having problems less than a week later after receiving the COVID-19 vaccine, she mentioned Wednesday. On 27Jan2021, her mother began having issues with her kidneys and has progressively declined since. Consumer stated her mother was swollen from head to toe with edema on an unspecified date and that was how this all kind of started. Her mother became very weak and didn't tell anyone. She fell using her walker on Wednesday and the EMS was called. Her mother told the EMS she wasn't hurt but was just too weak to get up and EMS got her up. Her primary care doctor sent her for an x-ray, and she had some wheezing in her chest. She was given an antibiotic for that. The patient fell again, and the EMS was called and had some face lacerations and stuff, so she was taken to the hospital. Consumer confirmed her mother was admitted into the hospital and was first diagnosed with a kidney infection and it has progressively gotten worse. Outcome of event kidney infection was not recovered; and outcome of the rest of events was unknown. Information on lot/Batch number has been requested.
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| 74 | 2021-02-23 | discomfort |
uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the...
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uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the giant hives were like fire ant bites/developed little hives on the inside of her arms, behind her knees, and on the tops of her feet; This is a spontaneous report from a contactable health care professional nurse, the patient. A 74-years-old female patient (retired nurse) received the first dose of bnt162b2 (BNT162B2, Lot Number EL9262) , via an unspecified route of administration in the right deltoid on 29Jan2021 at 11:00 (at 74 years of age) as a Single dose for Covid-19 Vaccination. The Vaccination Facility was 'movie theater'. No other vaccines were given within 4 weeks. Medical history included hypertension from 2020 ( doctor considered taking her off of blood pressure medicine because her blood pressure is very normal now), Prediabetes (diagnosed with Prediabetes about 3 years ago) and Allergic reaction to bee sting (numerous yellow jacket stings throat felt like it was starting to close, and tongue felt funny. Went to ER and Treated with Zantac and Epinephrine) and lost 55 lbs. (borderline high blood pressure was related to her weight). Concomitant medication included ongoing generic losartan (LOSARTAN) 50 mg, 1x/day for borderline high blood pressure, metformin (METFORMIN) 500 mg, 1x/day for glucose tolerance impaired. On 29Jan2021at 5 PM the patient started having some itching 'felt like she had a mosquito bite but on further investigation she noticed "giant hives all over my body'. She said she took some Benadryl Lot Number: P119923 Expiration Date: Apr2023 and 1 expired Zantac (Lot Number: NL4604, Expiration Date: Nov2019) on 29Jan2021 to help treat giant hives and itching. The giant hives 'kind of subsided' after she took the Benadryl and the Zantac, though she did remain itchy and uncomfortable all night. She said by the morning (30Jan2021) the giant hives were gone. She said that evening (30Jan2021) the giant hives came back again, and the giant hives were all over her body. She said the giant hives were like fire ant bites, she said the giant hives were just awful. She said she had a previously scheduled appointment with her doctor on Monday, 01Feb2021 (prior to developing the giant hives after her first COVID-19 Vaccine dose) but probably would have gone to see her doctor anyway, if she didn't have a prior appointment. She said she had taken pictures of her giant hives, her doctor believes the giant hives she experienced was a reaction the COVID-19 Vaccine's preservatives. She said her doctor still wants her to get the second COVID-19 Vaccine dose. Consumer stated Reported her giant hives were gone by Monday morning (01Feb2021), when she woke up. She stated during Monday (01Feb2021) into Tuesday (02Feb2021) she developed little hives on the inside of her arms, behind her knees, and on the tops of her feet. She said she has a residual itching that is lingering, but not continual. She said she has been taking one generic Zyrtec 10mg tablet per day, Lot Number: NL4604, Expiration Date: Nov2019. The events Hives and Itching was medically significant and uncomfortable was non serious. Treatment was given for itching and hives. Her doctor still wants her to get the second COVID-19 Vaccine dose. Patient second COVID-19 Vaccine dose is scheduled for 19Feb2021. The patient reported her doctor told her it would be a good idea for her to take one Zyrtec, each day, for 3 days before her next COVID-19 Vaccine dose. She said her doctor told her to pre-medicate with Benadryl on the day of her second COVID-19 Vaccine dose. The clinical outcome of Pruritus was recovering while Hives was recovered on 02Feb2021 and the outcome of uncomfortable was unknown. The events Giant hive, hives and itching were considered related to the suspect product.
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| 74 | 2021-02-24 | tremor |
Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is g...
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Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is going to pass out. Provided water, cold towel and being monitored by nurse. Denies any shortness of breath or difficulty breathing. States symptoms persist for the next 30 minutes while refusing to go to ED. Daughter arrives and instructs patient to ED. Escorted to ED with the patient still complaining of persistent dizziness, lightheadedness, and brief chest tightness which subsided within 5 minutes.
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| 74 | 2021-02-24 | flushing | flushed in face, high blood pressure, |
| 74 | 2021-02-25 | bell's palsy | Bells Palsy |
| 74 | 2021-02-25 | weakness |
I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on ...
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I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on the 25th until 1 pm on the 25th. My headache was moderate but relentless throughout those days and into the 27th. I was extremely tired, having no energy or interest in doing anything but lying down. My body ached all over and I was somewhat dizzy and nauseated. I took a Tylenol during the night of the 25th. Today is the 26th and I am still very tired and my eyes are bleary.
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| 74 | 2021-02-25 | unresponsive to stimuli, weakness |
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM...
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I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me. He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.
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| 74 | 2021-02-25 | pain in extremity | Painful shoulder and arm continues still, one month later |
| 74 | 2021-02-25 | pain in extremity | Sore arm headache muscle aches fever chills |
| 74 | 2021-02-25 | weakness, migraine |
WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WE...
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WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block
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| 74 | 2021-02-25 | burning sensation |
cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report fro...
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cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included allergic to a lot of antibiotics, always get reactions to drugs. Concomitant medications were unknown. The patient previously received ciprofloxacin (CIPRO) experiencing lip swelled, levofloxacin (LEVAQUIN) experiencing lip swelled, Prednisone experiencing burning cheeks. The patient experienced that her cheeks were red and burning, and upper lip swelling slightly, all on 12Jan2021. And it lasted a little over two hours. The patient was asking if it would be safe to take Benadryl before the 2nd dose of the vaccine. Outcome of all events was recovered on 12Jan2021.
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| 74 | 2021-02-25 | pain in extremity |
still a part of her forehead that feels like a live nerve; upper back started hurting/back was very ...
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still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.
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| 74 | 2021-02-26 | inability to speak |
15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drain...
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15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.
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| 74 | 2021-02-26 | weakness, tremor |
I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chill...
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I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chills and an all over listless feeling that started about 18 hours after I received vaccine and still remains 4 days later
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| 74 | 2021-02-26 | pain in extremity | Itch at site, sore arm, insomnia, brain fog, out of breath |
| 74 | 2021-02-26 | tingling, feeling cold |
PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS ...
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PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS STARTED. SHE WAS SENT TO THE ED FOR EVAULATION.
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| 74 | 2021-02-27 | pain in extremity |
Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the n...
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Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the next day with a fever at 5pm of 100.5; Sunday no temperature but loss of taste, diarrhea, stomach discomfort.
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| 74 | 2021-02-27 | tremor, weakness |
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash....
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Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-27 | weakness, tremor |
Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle ...
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Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-28 | tremor |
At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard...
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At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard I couldn't initially place a thermomenter in my mouth. Moments later, this was accompanied by throbbing pain in my lower back. Eventually I was able to take my temperature and I had fever. My daughter contacted my primry care physician who told us to go the emergency room. By the time we went to hospital, the chills had stopped as well as the lower back pain. I was quarantined (though they knew I had been vaccinated for COVID) until they tested me for COVID, the test came back negative in an hour. They did a number of tests and I was discharged around 6:00 pm that evening
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| 74 | 2021-02-28 | pain in extremity |
Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contac...
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Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#:not provided), via an unspecified route of administration from on 27Jan2021 (at the age of 74-year-old) at SINGLE DOSE for COVID-19 immunization at the hospital and paracetamol (TYLENOL), via an unspecified route of administration and dates at 2 DF, daily (every morning) for aches and pains. Medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot#: not provided) on an unknown date at SINGLE DOSE for COVID-19 immunization and says that she had no reaction to the first shot. The patient received the second dose and had a sore arm (in Jan2021) that was better today. She stated that in the morning she always took two paracetamol for aches and pains; and after she got the first and second shot she read three articles to do not take paracetamol before you get the vaccines as it might affect antibodies. However, no one published about this or said this at the hospital when she went to get the shot, they just asked what she was allergic to it. She would like to know if now she was not so protected because she took paracetamol and if this was a problem. The action taken in response with the adverse event for paracetamol was unknown. Outcome of the event was recovering Information on the lot/batch number has been requested.
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| 74 | 2021-02-28 | weakness, muscle spasms |
I became dizzy and then nauseous, increasingly dizzy. When I told my husband that I was getting up...
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I became dizzy and then nauseous, increasingly dizzy. When I told my husband that I was getting up to go to the restroom, perhaps to throw up, I found that I couldn't walk or make my arms and legs move in a controlled way. He helped me to a resting place on the floor. I asked him to call 911. I thought that I was having a stroke. Emergency personnel treated it as a pot overdose, because I told them that I had a bite of a pot brownie a couple of hours earlier. It was really a little piece and I doubt that it would be enough to have these results. I developed spasms throughout my body. My hands were unable to do tasks. I did throw up once at the hospital. I think that the pot issue was parallel but not necessarily the cause. I received IVs. One med was for nausea, Not sure what all. I went home about 1 AM after dizziness had lessened and spasms had stopped. Today I am a wobbly and weak, but no spasms. And I can walk and control my arms.
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| 74 | 2021-02-28 | weakness |
Reports x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and gen...
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Reports x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and generalized weakness
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| 74 | 2021-02-28 | tingling |
patient c/o tingling and numbness (slight) on L arm all the way to fingertips. No itching noted. No ...
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patient c/o tingling and numbness (slight) on L arm all the way to fingertips. No itching noted. No c/o pain V/S 98% RA 70 HR 19 cmp 130/60 BP @2:52pm v/s 97% RA 79 HR 19cmp 120/80 Patient stable symptoms improved left at 2:57pm
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| 74 | 2021-03-01 | muscle spasms |
With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl an...
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With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl and tylenol. On 21st sore all over, knees, back, shoulders, difficulty rising from seated position. It was as if all my joints were inflamed. Had strange bruise of left thigh, Dificulty walking. Took warm bath, muscle rub, ibuprofin, Pain continued on 10.,muscle spasms. When to ungent Care 2/27. Test Netrophils 61.7,lymphs 30.0, monos 6.0, eos,2.1 baso 0.2, AnC 2.99;Lymphs 1.45, monos 0.29, eos auto 0.10,BASO,001, WBC 4.8, RBC 4.70. HGB 12.7 HCT 39.8, MCV 84.7,MCHC 31.9.RDW<BLOOOD, 14.0,PLT'S AUTO,NA 141, K 4.1,CL 103, CO2 29. CREAT 0.86, GFR 77, BUN 15 , GLUC 112, ESR 23
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| 74 | 2021-03-02 | tremor |
12 hrs after shot I was suddenly sicker than I?d ever been in my life: body shaking chills, fever, ...
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12 hrs after shot I was suddenly sicker than I?d ever been in my life: body shaking chills, fever, headache, body aches. Today I still have fever, body aches, head ache, diarrhea. Haven?t been able to eat.
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| 74 | 2021-03-02 | pain in extremity |
Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-y...
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Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via intramuscular on left arm on 24Jan2021 at 18:30 at single dose for COVID-19 immunization. The relevant medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: autoimmune disease, PBC (Primary biliary cholangitis) (PBC is her autoimmune condition and was diagnosed 10 years ago). Concomitant medications were reported as none. The patient had sore arm with first dose on 24Jan2021. The outcome of the event was recovering.
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| 74 | 2021-03-02 | tingling | Tingly, nausea; pallor |
| 74 | 2021-03-02 | pain in extremity |
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen...
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light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
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| 74 | 2021-03-02 | hot flush | queasy stomach hot flash rapid pulse metalic taste |
| 74 | 2021-03-03 | flushing |
10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx...
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10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx 10:30, provided bottled water to drink, denies any difficulty breathing, throat swelling, or tongue swelling 11:00 finished bottle of water feeling fine left vaccine clinic accompanied by her husband 11:30 returned to vaccine clinic c/o thick tongue and difficulty swallowing, denies difficulty breathing. Sent to ED. ED note states that patient presented after "near syncopal episode" after developing lightheadedness and flushing after vaccination. Similar episode an hour later (prompting return to medical center). Denied chest pain or shortness of breath on presentation to ED. Described difficulty swallowing and "thick tongue" leading to her presenting back to clinic, but asymptomatic when arrived to ED. Oropharynx free of any swelling. EKG done but only showed sinus bradycardia. Patient observed multiple hours then discharged without any medical intervention taken.
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| 74 | 2021-03-03 | numbness |
Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too ...
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Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car, "I thought I felt numbness in my cheek. It didn't stay, went right away. My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal? It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"? It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.
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| 74 | 2021-03-03 | pain in extremity |
Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extr...
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Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extreme itching at site; lethargy; reporter let person know these events not terribly unusual, vaccinee (sp?) wanted to report because continuing to have this
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| 74 | 2021-03-03 | feeling hot, pain in extremity |
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right...
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Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
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| 74 | 2021-03-03 | pain in extremity |
The next night after getting my 2nd dose the upper part of my arm swelled 3 times the size of my arm...
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The next night after getting my 2nd dose the upper part of my arm swelled 3 times the size of my arm normally. The very next morning I woke up to my whole arm hurting and being swollen down to my wrist.
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| 74 | 2021-03-03 | pain in extremity |
Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat,...
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Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat, sore arm, fatigue. Symptoms faded during following day (Sunday) and by Monday left only with fatigue which resolved by Tuesday.
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| 74 | 2021-03-04 | burning sensation |
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning,...
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After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
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| 74 | 2021-03-04 | weakness |
Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and ...
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Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.
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| 74 | 2021-03-04 | pain in extremity | Enlarged nymph node under left armpit Swollen left arm with pain along the inner left arm |
| 74 | 2021-03-04 | pain in extremity |
Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chill...
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Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chills, no fever that i know of, headache, extremely painful left arm up & down, into shoulder & scapula. . Stayed home all day., took Tyleno, benedril dye free the day after injection when feeling so bad
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| 74 | 2021-03-04 | pain in extremity |
I received the first Covid shot. After a few days of soreness, it became itchy. Red blotch on arm...
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I received the first Covid shot. After a few days of soreness, it became itchy. Red blotch on arm that itches
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| 74 | 2021-03-05 | muscle spasms |
2/25/2021 7am I got painful cramps in Right Calf that lasted about 10 minutes. They subsided when I...
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2/25/2021 7am I got painful cramps in Right Calf that lasted about 10 minutes. They subsided when I got out of bed and moved leg and walked 2/26/2021 6am I got painful cramps in Left Calf lasted about 10minutes. They subsided when I got out of bed and moved leg and walked.
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| 74 | 2021-03-06 | pain in extremity |
Muscle pain in right upper leg, groin, side and front of leg. Enough pain that I am limping when I ...
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Muscle pain in right upper leg, groin, side and front of leg. Enough pain that I am limping when I stand up and can't walk very far, due to the pain. It's been going on for 12 - 13 days and is not improving. I had no leg injury that I could identify as the source of the pain.
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| 74 | 2021-03-06 | flushing |
pt felt flushed, slight sob, initial bp at 202/10, gradually decreased, continued to be slightly hig...
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pt felt flushed, slight sob, initial bp at 202/10, gradually decreased, continued to be slightly high, last bp at 177/82, per client, pt due for bp med tonight. Per MD, ok for pt to go home, pt no longer felt flushed.
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| 74 | 2021-03-07 | pain in extremity |
Client's daughter reports extensive bruising to right arm and increased soreness, starting about 10 ...
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Client's daughter reports extensive bruising to right arm and increased soreness, starting about 10 days post-vaccination. Bruising has continued to grow worse and states her mother "cannot use her right arm." Reports she has been to the ER twice but only pain medication given as treatment. Client denies any other symptoms or skin changes anywhere else.
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| 74 | 2021-03-07 | weakness |
Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with na...
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Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days. Tested COVID 19 positive. Found to be hyponatremic. Was treated with IV fluids. Discharged on 3/6/21. Follow labs on 3/8/21.
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| 74 | 2021-03-07 | tremor, feeling cold |
tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Head...
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tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19. She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.
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| 74 | 2021-03-08 | weakness |
1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5...
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1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5 days-nausea, weakness & fatigue - could not eat or smell or even look at food.
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| 74 | 2021-03-08 | pain in extremity |
First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. ...
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First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. Evening of day two: Headache started. and continues each day getting a little worse each day. Took Ibuprofen-helped slightly Day five: Bad headache all day and from previous night. Contacted doctor through MY Chart. He said persistent headaches with Pfizer vaccine were uncommon and suggested a treatment.. I declined as I had used that medication 30+years ago and didn't like it. Day six: Better Day seven: Better Day eight: Still with headache, sinus drainage, chest pain (like I was coming down with a cold) Day nine: No chest pain, drainage and headache, ringing in ears Day ten: More drainage and headache, ringing in ears
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| 74 | 2021-03-08 | pain in extremity |
Light headed and slight fever on day of injection. Since that time, arm is swollen and red and sli...
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Light headed and slight fever on day of injection. Since that time, arm is swollen and red and slightly sore.
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| 74 | 2021-03-08 | feeling cold |
On Sunday around 2:00 p.m. I got cold inside. Around 10:00 p.m. that same day I got a headache and ...
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On Sunday around 2:00 p.m. I got cold inside. Around 10:00 p.m. that same day I got a headache and my arm where I got the shot was swollen in that area and it hurt. On Monday, March 8th my headache was gone and the coldness went away, but my arm was still swollen, sore and red. On Tuesday, March 9th I called the doctor and he told me to put ice on it. When I get other shots my arm swells a little and it is gone in two days along with the redness, but not this time. It is warm to the touch too.
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| 74 | 2021-03-08 | flushing | itching on cheek and neck, redness (flushing). Evaluated by EMS-Cleared |
| 74 | 2021-03-08 | weakness |
pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, ...
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pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety. Pt called ambulance and transported to ER. She was tested for covid w/ negative results. Had blood work w/ abnormal results (mild leukopenia). She was prescribed Benadryl. Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax. She was released and told to FU w/ PCP. Her FU appt is 3/12/2021.
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| 74 | 2021-03-08 | flushing, tenderness |
red, flushed, hot, tender cheeks, face; noticed after removing face mask in car. This was not not...
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red, flushed, hot, tender cheeks, face; noticed after removing face mask in car. This was not noticed at vaccination facility because face was covered with protective mask. Pain in both eyes continued for several hours following.
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| 74 | 2021-03-09 | weakness, pain in extremity, cold sweat |
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold...
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11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
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| 74 | 2021-03-09 | flushing, difficulty speaking |
Called patient to follow up on her reaction to the COVID vaccine administered on 3/4/21. She was tra...
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Called patient to follow up on her reaction to the COVID vaccine administered on 3/4/21. She was transported by EMS to the ER after having anaphylaxis to her second Pfizer vaccine. She states she was hospitalized in the ICU overnight and was discharged home this afternoon. Patient feels she is doing much better. She does note feeling very tired from all the medications they gave her. She plans to call her PCP on Monday to schedule an appointment and has follow up scheduled with allergy specialist. She denies any further questions or concerns. Patient is appreciative of phone call. Progress Notes: 3/4/2021 Subjective Patient is a 74-year-old female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30-minute waiting period after the injection, the patient began to experience hoarse voice. She denied rash, difficulty breathing, difficulty swallowing, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. PMH of anaphylaxis x 3, with one hospitalization. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness (she later developed chest tightness when she was in the bay prior to epi-pen administration.) Patient denies chills, fever, malaise/fatigue, facial swelling, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain Hoarse voice.: Negative for nausea: + lightheaded.: Previous Reactions: anaphylaxis to medications. Never to vaccines. Pt's husband with her today. He states she progresses rapidly with her anaphylaxis and wishes for her to get epi pen now based on her symptoms. She typically starts out this way. Vitals: 03/04/21 1135 03/04/21 1140 BP: (!) 187/100 (!) 163/95 Pulse: 93 95 Resp: 18 16 SpO2: 100% 100% Physical Exam Constitutional: Appearance: She is well-developed. She is not toxic-appearing or diaphoretic. Comments: flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway. Voice is hoarse. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: benadryl 50 mg IM R leg antihistamines and epinephrine x 1 at 1136 in L leg Follow up response to treatment: good. She started to have return of symptoms when AMR was leaving with her. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Pt with early onset of presumed anaphylaxis that responded well to epi-pen. Pt sent to ED for closer observation/treatment via AMR. Husband voiced great appreciation of pt's care today. 3/4/2021 11:40 PM Addendum: ED charge nurse, RN was notified of patient coming.
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| 74 | 2021-03-09 | flushing |
Progress Notes APRN (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/4/2021, 8:45 AM Expand...
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Progress Notes APRN (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/4/2021, 8:45 AM Expand All Collapse All COVID VACCINE CLINIC 3/3/2021 Patient Date: 3/3/2021 Subjective Patient is a 74 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience diaphoresis. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , collapse, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Past Medical History: Diagnosis Date ? Allergy all year ? Anxiety ? Arthritis ? Asthma exercise induced ? Calculus of gallbladder without mention of cholecystitis or obstruction Cholelithiasis; ? Diabetes mellitus ? Diabetes mellitus, type 2; ? Diverticulosis of colon (without mention of hemorrhage) Diverticulosis without Hemorrhage ? Esophageal reflux GERD; ? Hearing loss ? Hypertension ? Irritable bowel syndrome Irritable Bowel Syndrome ? Past Hospitalization Diagnosis: Chest Pain, atypical; at: Health Center; Approximate Date: 18000101; ? Nextgen Comments Palpitations/SVT; Anxiety disorder; HRT; Microscopic hematuria ? Osteoarthrosis, unspecified whether generalized or localized, unspecified site Osteoarthritis; ? Other and unspecified hyperlipidemia Hyperlipidemia, Pure; ? Pancreatitis ? PONV (postoperative nausea and vomiting) ? Type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled; DM type II w/o comp; ? Unspecified essential hypertension Hypertension ? Unspecified hemorrhoids without mention of complication Hemorrhoids; ? Unspecified tinnitus ALLERGY REVIEW OF SYSTEMS: Patient complains of headaches (frontal, reports from using her hearing aids and is loud in the expo center. Present prior to vaccine today. ). Patient denies chills, fever and malaise/fatigue; Previous Reactions: none Pt reports she last ate around 10 am. She declines any food/snacks from bay today. Objective Vitals Vitals: 03/03/21 1355 BP: (!) 115/99 Pulse: 73 Resp: 16 SpO2: 97% Blood Sugar 134 collected at 1354 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic (no visual diaphoresis. ) HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Flushed sensation Pt observed for 15 minutes. t Symptoms resolved. BG good and pt able to ambulate w/o dizziness, lightheaded, sob, cp. Follow up with pcp if not improving or worsening. Continue to monitor BG and BP at home. Pt and pt's husband voices appreciation of care today. APRN Electronically Signed 3/3/2021 1:57 PM Division of Health.
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| 74 | 2021-03-09 | tremor, pain in extremity |
Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt be...
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Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt better when I woke up. I haven't felt completely well. On Monday 3/8 I had vertigo and nausea and my arm was sore. I feel disoriented, like I just cant concentrate well. extremely tired, I feel like I could sleep all day.
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| 74 | 2021-03-09 | feeling hot, pain in extremity, flushing |
her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getti...
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her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getting the vaccine, she felt like she had been punched in the arm; she is losing her voice; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL1283 and expiry date was unknown) via an unspecified route of administration, into left arm on 15Jan2021, as single dose for COVID Prevention. Medical history and concomitant medications were not reported. Patient stated that quickly after getting the vaccine, her face flushed out, and she got hot and sweaty. For three days following getting the vaccine, she felt like she had been punched in the arm, she was not just sore, but it felt like she had been punched. Stated that she was losing her voice. Patient received no other vaccines on the same day as the COVID vaccine. Patient wondering if other people are having the problem with the face flushing from the vaccine. Outcome of the events was unknown.
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| 74 | 2021-03-10 | weakness, feeling hot |
20 minutes after being vaccinated, patient felt,weak,feeling "I'm going to pass out", facial rednes...
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20 minutes after being vaccinated, patient felt,weak,feeling "I'm going to pass out", facial redness, feeling very hot. Remains alert and oriented x3. Brought to EMT monitoring area, VSS 148/72 HR 57 O2 100%, POC 86, very anxious with husband at bedside. EKG,with heart being monitored all within normal ,noted in database for rate as baseline. Cognitively presents anxious with noting calmness after 30 minutes with patient stating "I just feel not right". Has stated that her throat feeling cold. feeling spacey. Vitals have remained stable and offered to be transported to ER if preferred. Both she and husband agreed to be transported to Hospital. Their son was notified of this episode. Transported in stable condition to Hospital.
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| 74 | 2021-03-10 | one side paralysis, sensory loss |
74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital o...
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74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital on February 25, 2020 4 hours after the development of left-sided weakness. She was found to have an acute ischemic stroke. She has had slow progression with therapy but is now able to ambulate with a walker. She is in need of further rehab, hence the transition to swing bed. She denies any new complaints today, including headache, chest pain, shortness of breath, palpitations or feelings of tachyarrhythmias. The sensory deficits on the left side have improved in particular in her left upper extremity. She is noting some improvement as well and strength. No new focal neurological deficits
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| 74 | 2021-03-10 | pain in extremity |
Forty-five minutes after the injection my heart began to race to the extent that it was very alarmin...
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Forty-five minutes after the injection my heart began to race to the extent that it was very alarming. After an hour or so I took a very mild tranquilizer (.25 mg of clonazepam), which I take rarely (my doctor only prescribes .5 mg, 30 pills per year), and my heart calmed down. I also had "standard" side effects, namely, headache and sore arm.
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| 74 | 2021-03-10 | slurring, paralysis |
optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurologic...
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optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurological damage; unable to speak; changes in her eyes; Her right eye was bulging; Neither eye looked in the same direction, or able to track objects; known allergies: Apparently the Covid Vaccine by Pfizer; This is a spontaneous report from a contactable consumer. The consumer reported two reports for two separate vaccine doses for the same patient. This is the first of two reports. A 74-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included advanced stages of Multiple Sclerosis, Diabetes, depressant, covid prior vaccination. The patient's concomitant medications included diabetic meds (pills), anti-depressants, etc. The patient previously received the first dose of BNT162B2 in Dec2020 at age of 74 years old for COVID-19 immunization and experienced neurological setback and it wasn't terribly obvious at that time. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. The patient (mother of the reporter) suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time, in comparison to what occurred after she received the second vaccine. The patient suffered major neurological damage after the second vaccine; unable to speak, followed by an inability to move, chew, eat, etc. The reporter also noticed optical neuritis or changes in her eyes. Her right eye was bulging. Neither eye looked in the same direction, or able to track objects. The patient was currently in a long term acute hospital (pending clarification) with a tracheostomy and a food peg. She had advanced stages of Multiple Sclerosis. Reporter had since learned she had been advised by her MS doctors NOT to receive flu shots. The reporter had known this and would not have listened to the doctors at the nursing home, who recommended she receive the Covid Vaccine. This was serious. The reporter was awaiting medical records, which would provide exact dates, times, etc of the administration of the vaccines. Adverse events resulted in Disability or permanent damage. Known allergies: Apparently the Covid Vaccine by Pfizer. If treatment adverse events: unknown. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included unknown covid test: negative in Jan2021 (post vaccination). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 74 | 2021-03-11 | weakness |
Patient calling to report she received second COVID-19 vaccine 3 days ago. Patient is having difficu...
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Patient calling to report she received second COVID-19 vaccine 3 days ago. Patient is having difficulty functioning since vaccination. Patient is fatigued, body aches. Patient states that she is having a "hard time getting around" due to exhaustion. Able to stand and walk without difficulty. Able to do some of normal housework. No fevers. PCP performed labs - D-dimer elevated, troponin negative, EKG normal. Sent to ED for concern of PE. CTA-PE negative. D/C'd home in stable condition.
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| 74 | 2021-03-11 | pain in extremity |
Severe lower back pain across whole back about hand span width. Pain in right hip joint. Pain in lef...
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Severe lower back pain across whole back about hand span width. Pain in right hip joint. Pain in left upper leg with loss of strength in leg and could not lift leg up. The pain and discomfort in my back started to subside after 5-7 days. Today (day 10) the pain is gone from my hip. I still have weakness and discomfort in my left leg. Saw my M.D. today and will start physical therapy for the leg. Also first day not needing to take Tylenol which did not effect the pain at all for the first week.
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| 74 | 2021-03-11 | feeling hot |
body was burning up and face became very red. Had no temperature but was extremely hot after on weer...
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body was burning up and face became very red. Had no temperature but was extremely hot after on weer. Now have temporal pain in right hs hand temple with intermittent shooting pains
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| 74 | 2021-03-11 | weakness |
weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed,...
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weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed, hospitalized for 14 days. Gullian barre syndrome.
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| 74 | 2021-03-12 | feeling hot |
Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit three days after vaccination patient reports f...
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Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit three days after vaccination patient reports fever one day after vaccination and two days after vaccination suddenly felt hot and fell to her knees holding onto a couch. Able to ambulate to bed afterwards. Patient also reports swollen lymph node in left axilla. Patient denies chills, headache, blurry vision, nausea, vomiting, abdominal pain, myalgias, or respiratory symptoms. Does not report loss of consciousness, rash, or injury after fall but does report not eating or drinking prior to fall. Vital signs within normal ranges except blood pressure 135/70 mmHg. Advised to keep hydrated and eat well.
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| 74 | 2021-03-13 | numbness, tingling, flushing |
Almost immediate total body flushing and tingling, including numbness/tingling on left side of face....
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Almost immediate total body flushing and tingling, including numbness/tingling on left side of face. After 10 min. shivering though not feeling cold for about 5-10 min. Then later in afternoon continuous light numbness on left side of face. Slight headache. It's almost 3:00 p.m. on 3/14 and left side of face still feels somewhat numb but right side feels ok. Smile is even both right after the injection when nurse checked and now. Never a problem breathing.
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| 74 | 2021-03-13 | weakness | Dizziness, weakness, very tired |
| 74 | 2021-03-14 | pain in extremity |
Began with left knee and lower leg pain and swelling on 3/2/2021 at approx. 1500. Could barely put ...
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Began with left knee and lower leg pain and swelling on 3/2/2021 at approx. 1500. Could barely put weight on left leg. Placed bag of ice under left knee/lower leg to decrease pain/swelling for 20 minutes. Removed ice and wrapped a heating pad around left knee and went to bed for approx. 11 hours. Awoke at 0230 and almost fell to floor because left leg and knee was very swollen and painful. Left arm was swollen from upper arm to wrist. Whole face also appeared swollen. Denied redness and hardness. Went back to bed and awoke at 0930 - took two Tylenol for left arm soreness where injection was. Swelling slowly subsided throughout the day and she stated that she felt so much better in am of 3/5/2021 (Friday).
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| 74 | 2021-03-14 | tenderness |
This dose was administered in the wrong location. Resulted in redness, swelling, tenderness and swol...
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This dose was administered in the wrong location. Resulted in redness, swelling, tenderness and swollen lymph nodes under arm.
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| 74 | 2021-03-14 | flushing, hot flush | head ache, moderate lower G.I.cramps, Watery stools x 3, hot flashes and flushing after eating x4 |
| 74 | 2021-03-14 | facial pain, numbness |
lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her fa...
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lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown.
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| 74 | 2021-03-15 | depressed level of consciousness, unresponsive to stimuli |
1320: received initial injection of Pfizer 1330-1335: patient was not responding normally to husband...
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1320: received initial injection of Pfizer 1330-1335: patient was not responding normally to husband and caregiver 1335: our initial evaluation revealed she was semi-conscious, initially looking up when her name was called but then she stopped responding. Pulse ox was 99% on 2L O2 (chronic use), pulse 35. Blood pressure could not be measured. EMS was called. Pupils were both reactive to light but patient was not tracking. Despite sternal rub and physical stimulation, patient was not responding. She exhibited excessive salivation but no tongue swelling. Cardiac auscultation revealed bradycardia but regular rhythm. Lung sounds were normal bilaterally, no wheezing. 1340: EMS arrived, no vitals were obtained initially, patient taken to ED
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| 74 | 2021-03-15 | tremor |
Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/f...
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Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/feeling odd, along with the shakes and chills. VS taken and doctor notified of patient arrival. Reviewed Pt. History and any medical problems. Pt stated she is currently being treated for Sinus Problems and saw her doctor yesterday who encouraged her to get her vaccination today. She is on a Prednisone taper, and takes HCTZ for BP, and had a cardiac procedure done last year for chest discomfort, and nothing was found. Discussed with doctor the need to call EMS. Pt resistant to this but explained that they would assess her and then she could decide what kind of treatment from there. Pt still resistant to having EMS called, but call placed as per protocol. EMS Arrived and report given. Pt still resistant to being transported to hospital, after approx 15 minutes EMS convinced patient of the risks and needs of being transported versus the risks of driving there herself. Pt transported via EMS hospital.
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| 74 | 2021-03-15 | pain in extremity |
Raised rash on left arm. Rubbed Benitryl morning and night. Seems to be fading at this time. Very s...
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Raised rash on left arm. Rubbed Benitryl morning and night. Seems to be fading at this time. Very sore and sometimes itchy
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| 74 | 2021-03-15 | numbness, facial paralysis |
The patient began experiencing numbness on the right side of her face about 10 minutes after her vac...
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The patient began experiencing numbness on the right side of her face about 10 minutes after her vaccine was administered into her right arm. She reported that the right side of her face felt like it was red and swollen. She endorsed some drooping of her right eye. She was able to communicate fully, denied shortness of breath, difficulty breathing, and difficulty swallowing. She denied irritation at the vaccine site or any new rashes. Her only known allergy is to shellfish and iodine, which cause nausea and vomiting. The patient waited for about 25 minutes following the administration of the vaccine. Her symptoms did not begin to improve and it was recommended to contact EMS. The patient refused to call EMS and instead contacted her physician and left the facility.
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| 74 | 2021-03-15 | hot flush |
dizziness, hotflasshes, not feeling good. BS-109; VS 164/72-66; 173/95-72; 171/65-68; 160/65. ...
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dizziness, hotflasshes, not feeling good. BS-109; VS 164/72-66; 173/95-72; 171/65-68; 160/65. Dizziness resolved but still doesn't feel good.
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| 74 | 2021-03-15 | pain in extremity |
left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and...
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left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and at out side of left knee, sometimes directly in middle.
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| 74 | 2021-03-16 | numbness |
1. After few minutes numbness on right side of body for 2 days. 2. After 3 days erratic blood pressu...
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1. After few minutes numbness on right side of body for 2 days. 2. After 3 days erratic blood pressure and rate, now at day 17 and this shortness of breath, dizziness and erratic heart beat and rate continues...my heart rate of 160 is totally out of my norm.
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| 74 | 2021-03-16 | pain in extremity | Severe severe headache. Nausea and diarrhea. Plus sore arm. |
| 74 | 2021-03-16 | pain in extremity |
She got her vaccine and it was so high up that it hit a nerve in her joint. She did not have any sy...
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She got her vaccine and it was so high up that it hit a nerve in her joint. She did not have any symptoms after the injection. Went to bed, and woke up and her arm is swollen, it's like she has a frozen shoulder, is pounding pain, extremely tight, difficult to move, can't move it, and very constricted which prevents her from using it. The pain goes all the way down to her elbow. She cannot use the left hand, and when she tries to move her arm at the elbow has excruciating pain. She took 2 Tylenol which helped, but the pain comes back when it's time for more Tylenol and is also taking Ibuprofen but the symptoms are still there. Just to lift her arm up to put on the arms of a chair is painful with no mobility in the arm.
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| 74 | 2021-03-16 | feeling hot | hot, dizzy, tight throat EMS called, pt refused transfer, reaction resolved |
| 74 | 2021-03-17 | seizure | Resident had a seizure on 01/30/2021 at approximately 3:15PM. |
| 74 | 2021-03-17 | tingling |
caller states that his mother has become increasingly more tired, has a fever of 102, c/o chills, fe...
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caller states that his mother has become increasingly more tired, has a fever of 102, c/o chills, feeling dehydrated. Tingling in legs and feeling unsteady on feet. Was working in garage earlier today however had to lay down due to fatigue. Caller gave his mom 2 tylenol approx 20 min prior to calling, reports that he feels that is helping. Reports that she is A/Ox3 just "tired". Advised to increase fluids and monitor fever and effectiveness of tylenol. If she doesn't improve in the next hour, or if she begins to experience any chest pain, SOB or neuro changes, caller needs to take her to contact her PCP and/or ER. Spoke with son, his mom is doing much better, no fever and symptoms have resolved.
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| 74 | 2021-03-18 | tingling |
Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient ...
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Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient has hx of throat swelling from PO Sulfa. Pt alerted nurse at 9:35AM that she was experiencing a generalized prickle sensation. P60 O2RA 97%. At 09:54AM pt experiencing widespread prickle sensation, tightening in throat, difficulty swallowing, disorientation, and light headedness. Epi 0.3mg auto injector(Lot 0FM534) administered left leg 9:54AM per RN; BP 198/72 P75, O2RA 98%. EMS called 9:55AM, arrived at 9:59AM and assumed care of patient. Patient transported to Hospital.
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| 74 | 2021-03-18 | discomfort, pain in extremity, breast pain |
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast...
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Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
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| 74 | 2021-03-18 | pain in extremity |
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotte...
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she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
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| 74 | 2021-03-20 | pain in extremity | Bad headache, back ache, chills. shot arm hurt |
| 74 | 2021-03-20 | breast pain |
Pain on right side of rib cage and right side of right breast. Pain for approximately 1 week prior ...
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Pain on right side of rib cage and right side of right breast. Pain for approximately 1 week prior to seeing primary care MD.
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| 74 | 2021-03-21 | pain in extremity |
Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in ...
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Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in multiple veins & artery of left foot; several SVT &DVT in multiple veins & artery of left foot; Pain & swelling of foot; Pain & swelling of foot; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:00 AM (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Some antibiotics cause autoimmune issues, all sulphate drugs, narcotics. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot_number=EL3249) on 22Jan2021 12:00 AM administered in Right arm. Concomitant medications included thyroid (NATURE THROID) and multiple vitamin, taken for an unspecified indication, start and stop date were not reported. The patient experienced Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot. Pain & swelling of foot, all on 06Mar2021 01:00 AM with outcome of not recovered. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for events included given Eliquis to avoid further clotting. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
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| 74 | 2021-03-21 | tremor, pain in extremity, hot flush |
She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, st...
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She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness. She went to bed and covered up under lots of covers, and just froze. She put on extra clothes, layers of blankets and her legs felt swollen, painful. She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes. She felt as though her heart was racing, and her brain as well trying to figure out what was happening. Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9. At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday. When day broke on Saturday shew as not able to get out of bed for the entire day. She could not eat, had no appetite and drank water day. On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted. This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling. She is still not feeling completely well, but is on her way. Not steady on her feet yet. She took some Bayer aspirin for the symptoms.
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| 74 | 2021-03-21 | numbness | both feet/toes are numbish. (skin ) and now seems to be going up into the side of lower shin. |
| 74 | 2021-03-22 | weakness | High fever, general weakness leading to fall and hospitalization |
| 74 | 2021-03-22 | feeling hot |
Hot, itchy rash all over body (abdomen, arms, legs, head, inguinal region). Prescribed prednisone an...
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Hot, itchy rash all over body (abdomen, arms, legs, head, inguinal region). Prescribed prednisone and triamcinolone cream.
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| 74 | 2021-03-22 | muscle spasms |
excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Sy...
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excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Symptoms started 3/12. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache.
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| 74 | 2021-03-23 | weakness |
Patient received 2nd COVID-19 vaccination on 3/13/21. Manufacturer and lot # of vaccine not availab...
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Patient received 2nd COVID-19 vaccination on 3/13/21. Manufacturer and lot # of vaccine not available as administered at outlying clinic/facility. Date of 1st vaccination also unknown. Patient presents to ED after fall. Patient states that she has had significant weakness since receiving 2nd COVID vaccination. Patient states prior to COVID vaccine she was in her normal state of health. Patient troponin was elevated at 0.99. Patient denies any chest pain or shortness of breath. Patient diagnosed with non-STEMI. Treated with medical management including heparin drip and continue aspirin + Plavix + statin therapy. Patient was discharged to rehab facility on 3/18/21.
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| 74 | 2021-03-23 | muscle spasms |
patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruc...
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patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with history of muscle cramps.
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| 74 | 2021-03-24 | breast pain, hot flush |
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, ...
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First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme tiredness that sleep did not help. Also, hot flashes during night. took Tylenol. Second day, pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder. It had spread and was now a light pink. A small amount of dizziness.
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| 74 | 2021-03-24 | tingling | Pressure in the back of the ears, tingling all over, headache |
| 74 | 2021-03-25 | weakness |
Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest ...
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Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest pain, SOB, headache and dizziness, ankles and wrists aches.. sever spinal pain. Debilitating pain and weakness
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| 74 | 2021-03-25 | burning sensation |
The day after the shot I began a flare-up of psoriasis, an ongoing condition. By evening it had esca...
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The day after the shot I began a flare-up of psoriasis, an ongoing condition. By evening it had escalated to the point that my eyes were swollen shut. I had a fierce itching and burning of my face. I asked my husband if he would take me to the emergency room. He then suggested that he remembered having prednisone tablets. Without them I know I would have gotten much worse. I couldn't get in to see my dermatologist until another day later. They gave me a 40ml steroid shot. It called everything down but took another week to subside. I've had a similar reaction to the Fluzone shot back in Sept, 2020.
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| 74 | 2021-03-28 | unresponsive to stimuli |
Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became un...
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Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became unresponsive in her wheelchair and became blue with no palpable pulse. Patient had a DNR status and was not revived.
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| 74 | 2021-03-30 | bell's palsy, numbness | Bell's Palsy second occurrence. First occurrence 12/18 Numb toes on both feet |
| 74 | 2021-03-30 | feeling hot |
Face and ears are hot; This is a spontaneous report from a contactable consumer (patient herself). A...
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Face and ears are hot; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 28Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included none. She didn't know what to take and therefore has taken nothing. Patient states that she got the vaccine yesterday. She was calling about the COVID vaccine. She was fine, but then last night the skin on her face got hot on 28Jan2021. The rest of body did not. She did have a blanket on. Her face and ears are hot on 28Jan2021, the rest of her body was not hot. She wanted to know, she has called the doctor and has had no answer, she wants to know was she could she take aspirin or Tylenol. Her first dose was on 28Jan2021. Her face being hot started last night. It was just the skin on the face and ears that got hot starting 28Jan2021. She was going to be switching. Investigation assessment was none. She has had no issues with vaccines in the past. She has had 5 COVID test in total and all were negative. The last one was 2 weeks ago on an unspecified date in Jan2021. She last had an antibody test that was negative back probably on an unspecified date in Jul2020. The outcome of the event was recovering.
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| 74 | 2021-03-30 | weakness |
Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakn...
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Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
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| 74 | 2021-03-30 | weakness |
Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to ...
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Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to faint; I got really weak; Felt like I was going to threw up; Light-headed; I did feel like I was going to lose consciousness; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) (Batch/Lot Number: EL9261 and Expiry Date was Unknown) via an unspecified route of administration on 28Jan2021 12:45 at single dose for covid-19 immunization. Medical history included diabetes and asthma. Concomitant medications included empagliflozin (JARDIANCE) and lisinopril. Consumer (Retired Nurse) stated, "I had my COVID Vaccine first dose yesterday 28Jan2021 at 12:45 in the afternoon and I was standing in my kitchen cooking and all of sudden I got really weak and light headed and it was like black darkness was coming over my head. I was afraid, I was going to faint. My stomach was upset. I made up to the bathroom, sat on the toilet, had a bowel movement and felt like I was going to threw up, never did threw up. I got real tired from headache and I just sat there until I thought it was safe to stand, which I did. So, I was reading in my little brochure and it said what to call this number to report any side effect so I was not dizzy but I did feel like I was going to lose consciousness." The patient assessed the events as non-serious with outcome of unknown. Reported causality for COVID Vaccine to events for stomach upset, headache was related.
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| 74 | 2021-03-31 | cold extremities, weakness |
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si...
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a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
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| 74 | 2021-03-31 | pain in extremity |
doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is ha...
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doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 03Mar2021 (at the age of 74 years old) at a single dose for COVID-19 immunization. Medical history included lumbar spine infusion (operations on spinal cord) from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that the patient needed the call handler to speak slowly, she doesn't feel that well. She had the first dose of BNT162B2 last 03Mar2021 and the second dose will be on 23Mar2021. She said something was happening to her arm but it was not where the needle went in, that is not where it is. It hurt there at where the needle went in, in the beginning but now it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone. She hopes it was not a blood clot. She has been looking at the website and they say people could have blood clots and she does not know if this was a blood clot, she can't hardly lift her arm, it was the left side that the shot was in because her right side is partially paralyzed due to effect of lumbar spine infusion and so when she tried to get up sometimes she can hardly lift that arm and so she didn't know what to do if she should call the primary care doctor to see if she has a clot but she read it and it says to call this number if you are having compactions and she been on hold over and hour and a half. It was hurting and the feeling like she couldn't hardly raise the arm or get any kind of strength in it. She knew in Europe they have had few people who have had blood clots, and she thought could that be a sign of a blood, like blood not moving through her veins like it is supposed to. It is not moving it has not made it to her heart yet. She says it is associated with the product, this is the only thing she has had in her arm she knows it is the product. She said her birthday just passed. She turned 75 years old but when the issue started in her arm she was 74 years old. It did not start the first week, the first week it was just sore around where the shot went in but then last week it started happening where it was hurting down her arm and she was getting close to the second shot which she doubts she will have but it is the 23rd which is next week. She used to be 5'2" but the operations on her spinal cord, she guesses she might be 4''10 now. She does not know because she can't hold her head up straight because the doctor that fused it, she indented it instead of it being more out and because of that her head is forward and down. It was also reported that she hasn't been to the doctor she only goes to pain management for him to check out her body and everything and renew prescriptions. The outcome of the events was unknown.
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| 74 | 2021-04-01 | unresponsive to stimuli, seizure |
DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patien...
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DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patient is a 74 year old female who receives care through healthcare clinic and second healthcare clinic with past medical history of HTN, CKD, cardiomyopathy/congestive heart failure, atrial fibrillation on Pradaxa who presented to the ED 3/16 after suffering an out of hospital cardiac arrest at her dentist's office. Per report, patient had SBP in the 80s on arrival but was asymptomatic. Prior to start of any procedure (no reports of being given sedative medications), she became unresponsive. CPR was initiated and was found to be in asystole. She received 3 rounds of CPR with ROSC. CT head without acute abnormality. Chest XR showing mild vascular congestion and interstitial edema. Initial labs showing AKI, elevated liver enzymes, BNP >29,000, troponin 39, lactic acid of 11, INR of 6.6, PTT 62, APTT 87. UA with protein, nitrite, moderate blood. Urine culture ordered. Blood cultures ordered. In ED, patient was hypotensive requiring addition of vasopressors. Targeted temperature management was started. Ceftriaxone and flagyl started for possible urinary tract infection and aspiration. Patient with profound coagulopathy, INR increasing to 12.0 on arrival to the ICU. Two units FFP and vitamin K were given. Patient with escalating pressor requirements at this time so CT t/a/p was ordered showing multiple bilateral rib fractures, nondisplaced sternal fracture with small anterior mediastinal retrosternal hematoma, small right sided hemothorax, right chest wall hematoma, patchy bilateral airspace disease consistent with atelectasis/infiltrate/aspiration, diffuse GGO consistent with interstitial edema, enlarged pulmonary arteries consistent with pulmonary hypertension, cholelithiasis. FDP elevated and 2 units of cryoprecipitate given 3/16. Hemoglobin decreased to 5.9 3/17 with INR of 5.4. Two additional units of FFP and additional dose of vitamin K ordered. Two units RBCs ordered. CTA thorax and abdomen 3/17 re-confirmed hemothorax and chest wall hematoma but no active bleeding noted. CT bilateral LE showed no evidence of hematoma. Trauma consulted who recommended chest tube placement. Overnight 3/16-3/17, patient also noted to have seizure activity on EEG and patient loaded with Keppra. Head CT 3/17 negative for hemorrhage or other acute processes. Patient remained in status epilepticus 3/17am and additional Keppra load was given and neurology consulted. Received Praxbind for continued bleeding/coagulopathy. 3/17pm went into PEA arrest with 10 minutes of CPR with ROSC. Bronchoscopy following ROSC noted evidence of bleeding from multiple areas, clots removed. MRI brain showing diffuse anoxic brain injury. Propofol stopped 3/19am. After goals of care discussion this morning, all first degree relatives (daughter and son) all in agreement to transition to comfort care measures. I received call from bedside RN that patient had passed away. On exam, no heart or breath sounds appreciated upon auscultation for 2 minutes. No spontaneous movement or chest rise noted. No pulse palpated for two minutes. Pupils fixed and dilated. No response to noxious stimuli. Time of death 1400 3/20/2021.
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| 74 | 2021-04-01 | weakness, tremor |
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p...
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weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-06 | weakness |
her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fl...
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her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fluids/I was so dehydrated; hadn't eaten anything; stated she started salivating and then threw up; stated she threw up once; she had a severe headache; she was shivering all evening and she couldn't get warm; she had body aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, NDC number: Unknown, Expiration Date: May2021, Manufacturer: Unspecified) via an unspecified route of administration at right arm on 15Jan2021 at single dose for COVID-19 immunisation. Medical history of patient included knee pain and anxiety. Patient's concomitant medications included tramadol, paracetamol both 500 mg for knee pain and hydroxyzine hydrochloride (25mg tablet up to three times a day as needed by mouth, she does not take every day) for anxiety. On 15Jan2021 after vaccination patient experienced salivating and then threw up, stated she threw up once, severe headache, shivering all evening and she couldn't get warm, body aches, nausea, lost a lot of fluids/I was so dehydrated, hadn't eaten anything and her blood pressure was very low the next morning, she felt really weak on 16Jan2021. She required urgent care trip for IV fluids, "She was so dehydrated" and was "miserable" with her symptoms. She said she lost a lot of fluids and hadn't eaten anything. Patient wants to get the second COVID-19 vaccine dose because she is scheduled to have a knee replacement on 26Feb2021. She said she also had to deal with the pain in her knee, clarifying that is why she is getting a knee replacement. IV fluids (clarified as Saline), tylenol given as treatment. She reported when she got home she drank Pedialyte to try to rehydrate herself. She reported she went to urgent care on Saturday (16Jan2021), and by Monday 18Jan2021, she was feeling better, but she didn't golf on Tuesday, 19Jan2021. patient underwent lab tests and procedures which included blood pressure measurement which very low, influenza virus test and sars-cov-2 test was negative on 16Jan2021, blood test was fine. Patient said yes for investigation assessment. The outcome of event was recovered on 15Jan2021 for Increased salivation and Vomited and for all other event outcome was recovered on Jan2021.
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| 74 | 2021-04-07 | tingling |
Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulm...
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Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulmonary emboli involving the left upper lobe.
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| 74 | 2021-04-07 | unresponsive to stimuli |
Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way...
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Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way home from the vaccination and had chest pain and shortness of breath. Patient called their primary care doctor who requested reporting to the nearest emergency room immediately. Patient became unresponsive in the car. Patient arrived in cardiac arrest (arrival time noted to be 4/6/21 at 10:54 am, CPR began. Patient was intubated in the ER, and received epinephrine, amiodarone, and was defibrillated several times per ACLS protocol. Patient did not have return of spontaneous circulation and was subsequently pronounced. Per report, it was noted that patient was short of breath prior to receiving vaccination earlier in the day.
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| 74 | 2021-04-09 | pain in extremity |
elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to hea...
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elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; This is a spontaneous report from a contactable nurse reported for herself. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EP7534, expiration date: 31Jul2021, via an unspecified route of administration, administered in left deltoid (also reported as left arm) on 21Mar2021 at a single dose for COVID-19 immunisation; and rosuvastatin calcium, oral from an unspecified date (Lot Number: 20082811; Expiration Date: Jul2022) to an unspecified date, at 5mg every night for hyperlipidemia and Stage 3 kidney disease. Medical history included hypertension (diagnosed maybe 30 years ago, it is controlled), status ventricular tachycardia in 2001 (controlled), stroke (suffer stroke may be 12 or 13 years ago without the residual), Phase 3 renal disease/Stage 3 Kidney Disease, extracted tooth, bad tooth, aches and pain in her legs in Jan2020 and ongoing, and muscle pain. Patient did suffer stroke may be 12 or 13 years ago without the residual, it was incidental finding with the MRI with the brain because she had a bad tooth and they extracted the tooth, they decided to complain let's do a brain MRI of the brain and it showed an influx in right cerebellum but without residual she have no deficit, but they put her on Plavix first but the bruising was very severe so they changed it to Aggrenox which she successfully use Aggrenox now. Other medical conditions: Consumer stated, Folic acid, sodium bicarbonate, yes the Soda Bicarb (sodium bicarbonate) is for the Phase 3 renal disease but numbers are good, my DE creatinine all was normal but my nephrologist who happened to be a friend of mine said stage 3 renal disease. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX) taken for antiplatelet therapy, and paracetamol (TYLENOL) taken for pain. Concomitant medication: Consumer stated, "I take lots of medication, I mean I take Tylenol but none these have a direct correlation to the, I take Aggrenox, Aggrenox is antiplatelet, oh you are a pharmacist so you know that, that's Persantin and aspirin that's the combo, its antiplatelet." Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient previously took clopidogrel bisulfate (PLAVIX) and experienced bruising; folic acid, and Soda Bicarb (sodium bicarbonate) for phase 3 renal disease. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6203, expiry date: 30Jun2021, on 28Feb2021 for COVID-19 immunization. It was given in her left arm. She received the second dose of the Covid-19 vaccine on Sunday (21Mar2021). Her arm became sore on 21Mar2021. On Wednesday (24Mar2021), she was unable to raise her arm even in the shower. She saw her doctor on Thursday because she is on a statin and had aches and pain in her legs. They drew blood and found that she has an elevated CPK on 26Mar2021. It is not grossly but is elevated and has had muscle trauma. Could there be a connection? She reduced the statin to three times a week. The arm soreness is 30-40% improved. She can move her arm away from her body. It felt like she hit her elbow in the funny bone. It was an odd feeling down to her fingertips. The vaccine card indicates the vaccine was given in her right deltoid but it was given in her left deltoid (Left arm). She clarified that she is taking Rosuvastatin Calcium instead of Crestor. She added that she has Stage 3 Kidney Disease. The Nephrologist had told her that she needed to take Rosuvastatin Calcium 7 days a week instead of three. She has only had the pain since she started taking it daily. She stopped taking it daily this past Monday night. She told her doctor she will be taking it only on Monday, Wednesday and Friday. Consumer further stated, she had a very sore arm that she cannot lift over her hand, it feels like somebody hit her elbow. Consumer further reported and stated that she had the Pfizer second vaccine on Sunday (21Mar2021), by Wednesday (24Mar2021), she could not lift her arm, she went to her doctor yesterday and she was a nurse for 54 years so she did not think that was big deal, vaccine do give you a sore arm. However, she drew blood, well she didn't, the technician drew blood in that arm and her CPK is elevated, Patient stated "am I speaking to a pharmacist, doctor or, okay CPK indicated some kind of damage either to heart muscles to the brain or some skeletal muscle on the body. Mine has never been elevated, it's not growth fully elevated like indicative of cardiac event, However, it is elevated so I thought I should report this to Pfizer so I want you to know that, this is unusual finding." She was on a statin drug, she was on Crestor 5 mg once a day (clarified that she is taking Rosuvastatin Calcium instead of Crestor), however she cut it back to just 3 times a week now because her cholesterol numbers are good, my LDL and HDL are all good and the Cholesterol drug (Intent: Crestor) is known to cause this muscle aches and pain but this is so coincidental with this arm, her left arm where she received vaccine and this CPK being elevated and she thought perhaps Pfizer should be made aware. Consumer stated, "I have been a nurse, I am retired now, I am 76 but I had been a nurse for 54 years, I was at one time director of nursing, so I am familiar with the healthcare system and most medications but of course this Pfizer vaccine and Moderna and Johnson and Johnson these are brand new, this is a Covid pandemic so. Causality: Consumer stated, I kind of think there is connection there sir, because remember that it could be, muscle damage that elevates your CPK, it could be cardiac muscle, it could be a stroke, neither which I didn't have a heart attack. I was having a lot of muscle pain, prior because of the Crestor but that is the common side effect of any statin drug can cause muscle aches and pains. However, I thought there was quite a connection getting the vaccine in the right arm, not being able to raise my (incomplete sentence) now vaccine was Sunday which was I believe the 21st and this event did not happen until, I was sore Sunday evening but the unable to raise it was Wednesday, which was 3 days later yeah and the blood draw was yesterday morning and this morning my doctor called me to tell me that my CPK was elevated not grossly but enough to make the phone call. Consumer stated, the first one was on 28Feb2021 and the lot number was EN620, I need my magnify glass, there is one right here because it's so small, okay its EN62C or is it 0, it's hard to tell 3 is the last number. The second dose with lot number is EP7534. Consumer stated, Let me just look at the calendar to make sure that was Wednesday, I got the shot on 21st, yes sir, it was the 24th, the arm was sore even that evening the 21st (21Mar2021), evening of the 21st but the inability to move it was Wednesday the 24th, I could not move even move it away from my body so I was guarding it, today it's not as bad, I can move it but I still feel it like up in my shoulder. When confirmed if the event has improved, consumer stated, I would say yes but not totally gone. Consumer stated, I just took Tylenol that's all, I mean what I was going to do, I think I took, I know I took a shower last night Wednesday at night, I might let the warm water run on it, I might have, I don't remember, I took a shower regardless so." Lab test: Consumer stated, "I had blood work yesterday all my values were normal, Cholesterol was normal the only thing that was elevated was the CPK." Consumer stated, "I thought that it was necessary to report it okay, is there any way you can tell me is this a common occurrence where CPK elevates slightly." The action taken in response to the events for BNT162B2 was not applicable and for rosuvastatin calcium was dose reduced. The outcome of the events 'arm became sore, unable to raise arm, elevated CPK and muscle trauma (muscle injury)' was recovering while the outcome of the other event was unknown. The reporter considered the events 'arm soreness, unable to raise arm and elevated CPK' as serious (medically significant). The causality of the events 'arm soreness and unable to raise arm' was related to BNT162B2, and event 'elevated CPK' was related to rosuvastatin calcium.; Sender's Comments: Based on a drug event temporal association, the company cannot completely rule out a reasonable possibility that BNT162B2 caused the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-12 | weakness |
Two days after receiving vaccine patient and family reports patient developed nausea and headache. s...
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Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.
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| 74 | 2021-04-15 | weakness |
Patient is a 74 year old female with PMH of morbid obesity and seizure disorder who presented to the...
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Patient is a 74 year old female with PMH of morbid obesity and seizure disorder who presented to the ER on 2/13/2021 with weakness and fever. Patient tested positive for COVID-19 on 2/13 and was treated with a five day course of oral dexamethasone and remdesivir. Antibiotics were started on admission, but serial chest x-rays were mostly stable and all culture results remained negative. Antibiotics were discontinued on 2/15. Patient discharged to home on 2/18/2021
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| 74 | 2021-04-19 | cold sweat |
Patient was admiited to the hospital on April 9, 2021 complaining of tightness in her chest was note...
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Patient was admiited to the hospital on April 9, 2021 complaining of tightness in her chest was noted to be clammy with blue tinted lips and fingertips. Vital signs were BP 114/72, Pulse 135, Respirations 20, O2 Room air 80% Shortness of breath. While at the hospital she was diagnosed with a saddle embolus of the lungs and also a DVT on her left leg. She was sent back on hospice and is being treated with Eliquis
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| 74 | 2021-04-23 | pain in extremity |
Asthmatic bronchitis; Arm soreness; This is a spontaneous report from a contactable Consumer (Patien...
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Asthmatic bronchitis; Arm soreness; This is a spontaneous report from a contactable Consumer (Patient) via Pfizer-sponsored program. A 74-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date were unknown,) via unspecified route of administration, on 02Feb2021 (age at vaccination 74-years-old) at single dose for COVID-19 immunization. Patient had asthma before first shot but it was unclear if she was having more trouble now. The patient concomitant medication was not reported. The patient was scheduled for the second dose on 24Feb2021. The patient went to her pulmonologist for regular scheduled appointment for asthma who prescribed her prednisone and an inhaled steroid for her asthmatic bronchitis. The patient does not want to jeopardize the effectiveness of the vaccine so she was wondering if there may be any potential interactions between the steroids and the vaccine. The patient also stated that she had arm soreness for 1.5 days after the vaccine. Patient wanted to know if there was any information regarding the vaccine for patients with osteoporosis. Patient heard that there could be more symptoms/side effects from second dose of the vaccine. No PQC was present. Patient asked if she can have Prolia shot in between the 2 doses or she needs to delay. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 74 | 2021-04-23 | pain in extremity |
my arm was very itchy for 3-4 days/Itchy on arm where she bends her elbow; Arm soreness is in left a...
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my arm was very itchy for 3-4 days/Itchy on arm where she bends her elbow; Arm soreness is in left arm, which received the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 74-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265, expiration date not reported) via an unspecified route of administration in left arm on 11Feb2021 around 11:00 am (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included patient was allergic to Ibuprofen and gets swollen eyes. Can't take any medications with Ibuprofen in it. Hasn't taken Ibuprofen in years. Has no NDC/Lot/Exp to provide. Patient had no family medical history. Patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines were administered on same date of Pfizer suspect. Reportedly, there were no other products. No investigation assessment. There were no relevant tests. On 11Feb2021, patient experienced arm soreness is in left arm, which received the COVID-19 Vaccine and on 12Feb2021, started itching where she bends her arm across her elbow about six inches. Had no rash. Was very itchy that day and then it decreased a little. Itching went on for three to four days. Patient was little better in the morning. It was very itchy. Wants to know if that is an allergic reaction. Patient was scheduled for second dose on 03Mar2021, but she doesn't want to get the second COVID-19 Vaccine. Heard all sorts of stories. Patient asked how much she is protected if she just received one shot. Patient asked if you get a reaction can you take Benadryl after getting the vaccine. Patient also asked for his son who has a Penicillin allergy. He was supposed to get his first vaccine tomorrow. He is 45, is it ok to get the vaccine. No further details provided. The case was reported as non-serious. There was no PQC present. Patient was recovered from itching on 16Feb2021 and was recovering from arm soreness.
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| 74 | 2021-04-24 | migraine, one side paralysis |
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ...
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Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
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| 74 | 2021-04-24 | facial paralysis |
TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where...
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TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where she was, she didn't feel like herself; since this happened she makes mistakes; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the upper right arm on 06Mar2021 at 17:30 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus diagnosed in 1998-1999, high blood pressure diagnosed about 3 years later from Diabetes Type 2, like 2002 and little bit obesity. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. The patient's concomitant medications were not reported. The patient was not administered additional vaccine on same date as suspect vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. On 19Mar2021, the patient woke up so disoriented, she didn't know where she was, she didn't feel like herself, felt weird. She was staring out the window, and she daughter called her on the phone and caller told daughter she was feeling crazy, that morning was feeling weird and her daughter informed it was not morning it was in the evening and patient did not sound right. The patient's face from the nose down, looked like her teeth were melting, both cheeks looked like they were melting. She said her bottom lip was turned out and down, sagging, drooping. On 19Mar2021, about 18:30, the patient went to emergency room and was admitted to the hospital on 19Mar2021 around 21:00-22:00. On 19Mar2021 around 21:00-11:00, while she was in the hospital, her sugar had gone up to 310, hard time bringing her sugar down and blood pressure was way up, way higher than normal. In the hospital the patient was told she had transient ischaemic attack (TIA). The patient was discharged on 21Mar2021. The patient informed that since it happened she was making mistakes. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EP6955) via an unspecified route of administration in the upper right arm on 27Mar2021 as single dose for COVID-19 immunization. The informed that the she waited until after she received her second dose to inform about the events just in case something else happened. She stated she was fine now, everything was ok and stated she did believe the events were related to the vaccine. The patient followed up with her primary doctor, talked to him about her experience and going into the hospital. He instructed her to call Pfizer and let them know of her experiences. The patient underwent lab tests and procedures which included Computerised tomogram scan, Magnetic resonance imaging on unspecified date in Mar2021 and sugar 310 and hard to bring down, blood pressure was way up on 19Mar2021. The outcome of event since it happened she made mistake was unknown and rest all events was recovered on an unspecified date 2021.
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| 74 | 2021-04-26 | pain in extremity |
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness...
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chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) . Medical history included atrial fibrillation from 2019 (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019 , medical device implantation (Watchman device inserted), anaemia , oesophagogastroduodenoscopy , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date. The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage. The patient experienced feeling occasional pain and tightness to my heart on 30Jan2021 with outcome of not recovered , chest pain on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was on 28Jan2021 with outcome of recovering , headache on 28Jan2021 with outcome of recovering , left arm pain on 28Jan2021 with outcome of recovered. No follow-up attempts are possible. No further information is expected.
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| 74 | 2021-04-26 | tremor |
troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her h...
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troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
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| 74 | 2021-04-27 | pain in extremity |
Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of so...
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Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of sorts; Arm was sore; This is a spontaneous report from a contactable other hcp (nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 18Jan2021 at 09:00 (Lot Number: EL3247, Expiration Date: Apr2021) as single dose for COVID-19 immunization. The patient's medical history included spinal fusion surgery from 2019 to an unknown date. The patient previously received 1st Shingrix injection and experienced her arm turned really red and swelled up (so her doctor told her not to take the 2nd injection). There were no concomitant medications. On 19Jan2021, the patient experienced arm was sore. On 21Jan2021, the patient felt out of sorts. On 22Jan2021, the patient experienced muscle aches and pains. She is not sure if the muscle aches are due to her just getting old or from the vaccine. The muscle aches are especially in her legs. On an unspecified date, the patient experienced aching legs, gradually getting worse and her memory is affected. She is gradually getting worse, but doesn't know if it's the weather, or is it a possibility that it's the vaccine. The patient's memory is affected, then clarified that it has nothing to do with the vaccine, she is just getting old. She asked if people have reported muscle aches and pains for weeks after. She is due to have the second injection on 08Feb2021. No family medical history relevant to events. The events did not result in emergency room visit or physician office visit. The outcome of the muscle aches and pains was not recovered and was unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.
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| 74 | 2021-04-27 | weakness |
couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; couldn't con...
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couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed; labored breathing / Breathing difficult; swelling face; swelling face, mouth, tongue/my skull was swelling; swelling face, mouth, tongue/my skull was swelling; swelling face, mouth, tongue/my skull was swelling; Dizzy; weak; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot ER8727, second dose) solution for injection intramuscular in the left arm on 22Mar2021 at 09:00 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: sulfa drugs. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, lot EN6198) for COVID-19 vaccination on 01Mar2021 and experienced nausea, dizzy, weak, feeling unwell, and sore arm at injection site. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Mar2021 at 09:30, the patient experienced labored breathing, swelling face, mouth, tongue/my skull was swelling, out of breath with little exertion, dizzy, and weak. On 23Mar2021, the patient couldn't concentrate, think, read, be productive, sort papers etc. spent 3 days in bed. The events resulted in emergency room/department or urgent care. Treatment for the events included EPIPEN, steroids, ZYRTEC, famotidine. The outcome of the events was recovering. The patient was not test for COVID post vaccination.
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| 74 | 2021-04-27 | unresponsive to stimuli |
post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report r...
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post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report received from a contactable pharmacist. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 20Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. It was reported that patient was not pregnant. Facility type vaccine was reported as unknown. The patient's medical history included acute respiratory failure with hypoxia, cardiac arrest, transaminitis, and diabetes. It was unknown if patient had COVID prior vaccination. The patient's concomitant medications were not reported. It was unknown if patient received other medications in two weeks and if she received any other vaccine in four weeks. The patient previously received first dose of BNT162B2 on unspecified date at single dose for COVID-19 immunisation, lisinopril and hydrochlorothiazide/triamterene (DYAZIDE) both reported as known allergies. It was reported that patient was brought in by emergency medical services (EMS) status post-cardiac arrest. Per EMS she was driving to urgent care (unclear why). She just got her second Pfizer vaccine. At urgent care she collapsed and cardiopulmonary resuscitation (CPR) was initiated immediately. EMS arrived and her initial rhythm was pulseless electrical activity (PEA). They placed a gel and administered 3 rounds of CPR with 3 onset epinephrine. No shockable rhythm. Patient arrived at hospital intubated and unresponsive on 20Apr2021. Duration of hospitalization was reported as two days. The events were reported as serious with criteria hospitalization and life-threatening illness (immediate risk of death from the event). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient was tested for COVID post-vaccination. The outcome of the events was resolving Information on lot number/batch number has been requested.; Sender's Comments: The reported events would seem unlikely related to suspect vaccine BNT162B2, but more likely due to underlying cardiovascular morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-28 | weakness | Severe chill, fever 100,6, headache , weakness |
| 74 | 2021-04-30 | difficulty speaking |
She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burni...
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She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burning; Difficulty breathing; chest congestion; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported that she started to receive the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) via an unspecified route of administration in arm left on 03Mar2021 08:45AM (at the age of 74-year-old) at single dose for COVID-19 immunisation. First dose of BNT162b2 (Lot number GM or EM9809) was taken on 10Feb2021 (at the age of 74-year-old) in left arm (way up high on the shoulder) for COVID-19 immunisation. Relevant medical history included bronchitis, chronic obstructive pulmonary disease (due to environmental toxins), allergy to different dyes (allergic to yellow, purple, and blue dye) and allergy to medications. The patient has never been a drinker or smoker. Concomitant medications were not reported. A week or so after the second dose, she thought she was having a cold. It has affected her voice and breathing. She thought she had bronchitis. She was going to her doctor on 04May2021. She had a hacking cough and she doesn't know what she has if it isn't a cold. She wondered if it was connected to the vaccine or is it bronchitis. The more she talks the more difficulty in her chest. She was prescribed Robitussin DM cough syrup by her doctor and was taking honey lemon cough drops. She also had congestion in her chest ever since. She has been having like a cold in her chest. It was heard how she was sounding. She never thought it was connected to the vaccine and never expected this to last for this long. The patient asked whether it could be a residual side effects of the vaccine and questioned if this could have had any effect on the COPD. She stated she was not having any problems with it and she has had it for years. Her cough has been the same, she takes a dose of DM cough syrup or a cough drop during the day. Robitussin was working. She was drinking lots of fluids, between 74-96 ounces of water per day. The doctor told her she had A influenza, but she thought she had COVID because she had all the symptoms, but they said A influenza and treated her for influenza A. That morning she had difficulty breathing like bronchitis, her chest was burning inside and was always like that, her talking aggravates everything and she had deep breathing. Her physician said her chest was clear after she thought she had bronchitis at her previous visit. She does not have any questions, she was calling to report an event, she is calling her doctor for further guidance. Cough, difficulty breathing, voice changed required a visit at physician office. Onset date for hacking cough, voice affected, chest burning, difficulty breathing and chest congestion was 10mar2021, while onset date for the other events was unknown. Hacking cough, voice affected, chest burning, difficulty breathing and chest congestion were not resolved, outcome of the other events was unknown.
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| 74 | 2021-04-30 | pain in extremity |
arm soreness.; This is a spontaneous report received from a contactable consumer (patient). A 74-yea...
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arm soreness.; This is a spontaneous report received from a contactable consumer (patient). A 74-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Mar2021 at 11:30 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included vitamin B, vitamin C, hemp, biotin, lutein, aloe vera, and chlorzoxazone, paracetamol (GIN). The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 16:00 the patient experienced arm soreness. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of arm soreness was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
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| 74 | 2021-04-30 | numbness and pain in extremities, pain in extremity |
slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, t...
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slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, there was pain; arthritis; it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there; nerve problems; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in left arm on 01Apr2021 11:30 (Batch/Lot number was not reported) at the age of 74 years old as single dose for covid-19 immunisation. Medical history included pain from back and neck surgery she had predating treatment with the vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 11Mar2021 11:30 am in her left arm at the age of 74 years old for covid-19 immunisation and didn't feel anything different. The patient received the second dose on 01Apr2021 at 11:30 am in her left arm. Reported the first dose she didn't feel anything different. This time she didn't feel anything different until this morning. Added her arm was feeling heavy (Apr2021), she thought maybe she needed to exercise it, and she slept on that side mostly. She reported she was having a slight pain in her arm. Mentioned she also had arthritis and nerve problems (Apr2021). Added it was not swollen, but right where she got the vaccine, just a little, there was pain (Apr2021). She was asking should she just exercise it. Added it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there (Apr2021). Added it was young and it had not scattered out yet. She thought the slight pain in her arm started a few days after the second dose of the vaccine, about 05Apr2021, and now it was better than when she first noticed it. Mentioned she was concerned about getting the vaccine because of her other problems but her doctor told her to go ahead and get it. The outcome of the event slight pain in her arm was recovering, of the other events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-05-06 | weakness |
I was hospitalized with covid; I was hospitalized with covid; kind of weak; tired; This is a spontan...
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I was hospitalized with covid; I was hospitalized with covid; kind of weak; tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Last week (unspecified date), she was hospitalized with COVID, just came home after a week in the hospital, just came home last night. She was asking whether she can get the second dose and if there is any guidance on timing of the second dose. She was in the hospital 2 weeks ago and they tested her, and she was negative and last Monday she didn't feel good and went to the hospital and she has COPD and she tested positive on Monday and they kept her. She already has 1 shot and is supposed to get the 2nd on the 24th and she doesn't know if she should wait 14 days. Stated she was kind of weak. She was starting to get tired and not able to complete report. Clarified it was the Pfizer Covid vaccine and she got the 1st dose 30Mar2021 and was due for the 2nd dose 24Apr2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on Apr2021 then positive on Apr2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-05-07 | discomfort |
Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The h...
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Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158; head congestion/pressure; head congestion/pressure; Headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiry Date of COVID-19 Vaccine: unknown), via intramuscular in left arm on 01Feb2021 15:30 as single dose for covid-19 immunisation. Medical history included cancer from Nov2017, Verbatim was reported as cancer, she explains she started chemo in late Jan2018 and ran through that year. Starting in Aug2018, she had radiation every day, Intestinal cellulitis, this was diagnosed about 8 years ago; kidney problem and blood pressure. Concomitant medications included simvastatin 40 mg, tablet via mouth at once a day at night taken for blood pressure, start and stop date were not reported, caller verifies it was through insurance and is dispensed in a pharmacy bottle. lisinopril dihydrate 10 mg, tablet via mouth once a day before she goes to bed taken for blood pressure, start and stop date were not reported, it was dispensed in a pharmacy bottle. On 02Feb2021, the patient experienced headache; on an unknown date experienced blood pressure high/ her blood pressure got high, the bottom number (diastolic) got up to 101. the highest the top number (systolic) got was 158, head congestion/pressure. The report received as, caller received her COVID-19 shot on 01Feb2021. She is recorded to get the next vaccine on 19Feb2021. However, she read to not get the second vaccine before 21 days. She had trouble with first shot and is worried about getting in early. The caller confirms she received the vaccine on Monday, 01Feb2021.The caller states right at first while receiving the COVID-19 vaccine, she felt it go into her body. She clarifies further she felt it inside her. She could feel it. That didn't bother her or anything. She may have gotten a slight headache that night, but she had a worse headache the next day. The next day, Tuesday, 02Feb2021, she had a headache for most of the day. She was congested in the head. She wasn't normally congested in the head or have like pressure, the vaccine made her have it. She took Mucinex, but that didn't relieve her headache. She took Tylenol and that helped for a while. Caller provides the following product information for the Mucinex and Tylenol she took. Caller states she is sure the Mucinex (Lot: W000597049, Expiry date: Nov2014) was old because she doesn't take it very often. The caller clarifies she doesn't have Tylenol (Lot# 4HE16818, Expiry date: May2017), she actually has the Acetaminophen (Pain Reliever/Fever Reducer). What she was most worried about was what happened around Wednesday. She clarifies it wasn't the day after receiving the vaccine, it was the next day- Wednesday, Thursday, and Friday. Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158. Having that bottom number at 101 was kind of scary. She was on blood pressure medicine and her daughter was going to take her to the hospital, but she went ahead and took her blood pressure earlier than what she would normally take it. The blood pressure medicine brought her blood pressure down within a half an hour. When probed for the outcome of her blood pressure, she explains she hasn't taken her blood pressure in the last day or two but she can tell when her blood pressure was high so she doesn't go through the trouble of taking it when it was not. She verifies she has recovered completely from the high blood pressure. Caller confirms she didn't go ahead and go anywhere. It was years and years, she doesn't take flu shot. Caller mentions her husband took the COVID-19 vaccine the same time as her and had no ill effects at all. The patient was not experienced the events in emergency room or physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: high and 158/101 on an unknown date (the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158. Having that bottom number at 101). Therapeutic measures were taken as a result of the events with Mucinex, Tylenol and Acetaminophen (Pain Reliever/Fever Reducer). Outcome of the event Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158 was recovered on an unknown date and for remaining events outcome was unknown. Information on Lot/Batch number has been requested.
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| 74 | 2021-05-07 | tenderness |
Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyeli...
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Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid; it started down my forehead and blistered.; top of my scalp near the crown there is little tenderness still. It was really tender.; She touched my hair and I didn't jump out if my skin but it hurts.; This is a spontaneous report for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included pulmonary hypertension from an unknown date, arthritis from an unknown date, and rosacea from an unknown date. Concomitant medications included atenolol taken for an unspecified indication, start and stop date were not reported; enalapril maleate (LOTRIAL [ENALAPRIL MALEATE]) taken for an unspecified indication, start and stop date were not reported; guanidine taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported, and other vitamins over the counter start and stop date were not reported. The patient experienced shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid on Mar2021 with outcome of unknown, it started down her forehead and blistered on Mar2021 with outcome of unknown, top of her scalp near the crown there is little tenderness still. it was really tender on Mar2021 with outcome of unknown, and she touched her hair and she didn't jump out if her skin but it hurts on Mar2021 with outcome of unknown. As treatment, the patient received valacyclovir, that is for 7 days, 1000mg Once a day. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information the reported events more likely represent intercurrent medical conditions which were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Investigators, as appropriate.
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| 74 | 2021-05-07 | pain in extremity |
a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her ches...
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a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her chest, arms and midriff developed; rash on her chest, midriff, arms, and bottom of legs; She states that she experienced a headache and a sore arm; She states that she experienced a headache and a sore arm; This is a spontaneous report from a contactable consumer (the patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date was not reported), via an unspecified route of administration Arm right on 06Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613; expiration date was not reported), via an unspecified route of administration on 27Mar2021 (at the age of 74-years-old) as single dose for covid-19 immunization. The patient's medical history Included High Blood Pressure. Concomitant medications included diphenhydramine hydrochloride(BENADRYL) for rash; coal tar, dimeticone, zinc oxide(ECZEMA CREAM) for Itching; Metoprolol Tartrate; SIMVASTATIN; LOSARTAN; POTASSIUM CHLORIDE (KLOR CON) for potassium dropped; Amlodipine Besilate; hydrochlorothiazide for high blood pressure. On 11Apr2021, the patient noticed a measly like rash on her chest, midriff, arms, and bottom of legs, measles and it was very itchy, On 28Mar2021 Headache recovered on 2021, on 27Mar2021 a sore arm recovered on 28Mar2021. The patient instructed to took Benadryl for a week and if the rash persists to come in to the office for an examination and also eczema cream in addition to taking the Benadryl for the itching. Outcome of the events rash on her chest, arms and midriff developed (rash), itchy was not recovered, measles outcome was unknown, headache and a sore arm outcome was recovered. The patient received the second dose on 27 MAR 2021. She experienced a headache and a sore arm for day and a half after the vaccine. Then last week she also had a headache for two days in a row, but that could be due to the change in the weather, she doesn't know what that is. She said that a week and a half ago a rash, a measles like rash on her chest, arms and midriff developed. She wasn't sure if it was because she was working outside, or related to the vaccine. She did find a couple of ticks on her. She called the local farm bureau and they said no, it wasn't from the ticks because the ticks would of burrowed their head into the skin. It was probably because she was outside. The patient has been taking Benadryl do to the fact that she has been outside and she has been very itchy. Everything is in bloom right now, but she was wearing long pants and long sleeves with gloves. The patient's itching is horrible. The patient night before up all night took Benadryl. She got a cream her husband use to used for eczema, it was an anti-itch cream, and she also used Aveeno eczema cream that has calamine lotion in it. The patient hasn't gone and seen her doctor yet because she felt better two days later and thought it was subsiding. The patient might be because she takes a shower and then she is alright for a couple of hours because of all the creams she is using. The last night she was up till 3 am because of the itching. She stated that she knows you are not suppose to take other peoples medication but she had Prednisone 10 mg in the house, from her husband when he would have eczema flare ups, and she took that at 3 in the morning. She said that her doctor thought there has been too much time from when she got the vaccine for it to be related so she googled and it said that people can get a measles like rash, and read something about being on their toes, but hers wasn't on her toes. Her rash was just her chest, arm, part of her legs and midriff. She stated that she is nervous, and she lost her husband a year ago on 28 APR and she doesn't know, if it is just nerves/stress or if it due to the reaction. The patient when she went to go get the vaccine they had asked her if she ever had reaction to a vaccine and she said a year ago when she had the pneumonia shot, she got cellulitis 2 inches above and 2 inches below the injection site. Her doctor thought it was cellulitis and she had to take antibiotics for a week. She stated that she had to wait longer then the normal 15 minutes because of her previous reaction so they made he wait for 30 mins when she got the covid vaccine. The first shot did not hurt at all. She asked that because she said that the second vaccine hurt immediately, it was discomforting. She thought she hit a nerve. She said it was like someone ran a nail down all the way down to her elbow. She doesn't know if she hit a nerve or what, but it was very painful. Clarified her headache started Sunday night after the vaccine and went away Monday. The patient thought the rash might be shingles, but then she was like no, that is only suppose to be on one side of a body. She stated that she needs to get the new shingles shot because the one that she had years ago isn't good anymore. She hasn't had new shingles immunization yet because she had to get the COVID shot. She doesn't know if the itching started because she saw the ticks or not but it started immediately. She states that she got the ticks off of her and shook her hair out. She states that she took Benadryl, she didn't have the fast acting Benadryl she had the 24 hour relief Benadryl. She went to the store and got fast acting Benadryl and has been taking them ever since Monday. She took Benadryl 25mg two only at night. Lot S200513 exp. May 2023. The patients second dose received on 27Mar2021 on right arm with lot number ER2613. She was told to get the vaccine in the dominant arm which is her right arm. She used to always get vaccines in her left arm because you were suppose to get it in her nondominant arm because of the movement. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up #1(PRD 22Apr2021): This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported for herself that: updated new events Headache: (From: 28Mar2021 To: 2021), sore arm: (From: 27Mar2021 To: 28Mar2021), a measles like rash on her chest, arms and midriff developed. Updated Concomitant Products Metoprolol, hydrochlorothiazide, simvastatin, Losartan, Klor-Con, Amlodipine for high blood pressure, she states that the last bone density test she had her numbers were good but her doctor put her on this prophylactically. Critical Calcium supplement maximum plus for bone density. The patient's blood pressure medication and vitamins but they haven't changed since she has been going to her current doctor for 5 or 6 years. No follow-up attempts are needed. No further information is expected.
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| 75 | 2021-01-05 | tingling |
Patient reported tingling in her right fingers but reported to Heather that she was fine as of 3:06...
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Patient reported tingling in her right fingers but reported to Heather that she was fine as of 3:06pm
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| 75 | 2021-01-10 | pain in extremity |
Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 ...
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Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 hours later chills started . Both symptoms continue 12 days later.
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| 75 | 2021-01-10 | pain in extremity |
Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ ...
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Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ there are pieces of blood or something is different; This is a spontaneous report from a contactable other Health Professional (patient). A 75-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization, also reported as for work. Medical history included ulcer (15 to 20 years before 06Jan2021). Concomitant medication included prasugrel from Apr2020 and ongoing as blood thinner, acetylsalicylic acid, ascorbic acid (ASPIRIN) from Apr2020 and ongoing as blood thinner. The patient went to the bathroom in the morning 06Jan2021, she had to poop. When she wiped, it was reddish looking. The patient stated her stool color was normal, but the tissue paper is red after wiping her anal area. At first she thought hm oh well. Then she had been to the bathroom a couple of times 06Jan2021, and that the same thing happened. She had never experienced that before. It seems to her that there were pieces of blood or something was different. She wasn't hurting or anything. She was not weak or anything at this time. Her arm was a little sore, but she expected that. She was concerned about the color. She worked in the mammography department. She didn't have a prescribing doctor. She got it at work. She had noticed a difference of color in her poop. It had been the same all day. The outcome of the reddish poop was not recovered, of sore arm was unknown. The patient asked would the vaccine cause rectal blood upon wiping after defecation?; Sender's Comments: Reported blood in stool is considered intercurrent and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-01-10 | pain in extremity |
Mild arm soreness at site the following day Significant fatigue on the following five days and now ...
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Mild arm soreness at site the following day Significant fatigue on the following five days and now Heart palpitations and elevated BP on day four Mild nausea on day five
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| 75 | 2021-01-11 | involuntary muscle movements, depressed level of consciousness |
At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, o...
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At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, observed resident seated in a chair, blankly staring at the wall with no loss of consciousness. Blank stare accompanied with mild jerky movement. Resident was safely assisted to bed. Oxygen at 3lpm was administered. Petit mal- like seizure lasted for 5 minutes. Resident regained prior level of alertness and doesn't recall what had happened. Resident with no known history of seizure disorder.
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| 75 | 2021-01-13 | weakness |
Feels a little weaker/ a little weak like after the Flu shot; Feels a little weaker/ a little weak l...
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Feels a little weaker/ a little weak like after the Flu shot; Feels a little weaker/ a little weak like after the Flu shot; This is a spontaneous report from a contactable nurse (patient). A 75-years-old female patient received the second dose of of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 06Jan2021 at 0.3 mL single (reported as 0.3cc injection) for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The had labs in Dec2020 and everything was ok. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot and first dose BNT162B2 on 16Dec2020 (75-years-old) and experienced dental implants and bridge fell out, bones were hurting her, pain in hip. It was reported on 06Jan2021 1PM (06Jan2021 13:00) was kind of weak. And felt a little weaker on 06Jan2021 and 07Jan2021. She did not have a temperature. She wants to know if this only happened to her or if it was a coincidence. She felt ok, but a little weak like after the Flu shot. The event outcome was unknown.
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| 75 | 2021-01-13 | muscle spasms, seizure |
Patient given vaccine. Within 5 minutes husband said she?s having another spasm. She was being moni...
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Patient given vaccine. Within 5 minutes husband said she?s having another spasm. She was being monitored for 15 minutes after the injection. After the spasm it appeared to. become a seizure and passed out for 5 minutes . Husband said she missed her medicine and needed her carbidopa/levodopa. 911 arrived and administered oxygen and took to the hospital.
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| 75 | 2021-01-13 | tenderness, feeling cold |
after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; n...
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after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; not feeling very good. Next day same prblem especially chilled; went to bed under blanket to warm up Its now 12:36 next day, no improvement
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| 75 | 2021-01-14 | tingling |
Patient reports tingling in Left arm following vaccine administration. Tingling went from site of in...
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Patient reports tingling in Left arm following vaccine administration. Tingling went from site of injection down arm to 4th and 5th fingers on left hand. Declines any headache, dizziness, numbness. Can feel touch to hand/fingers
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| 75 | 2021-01-17 | pain in extremity |
altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontane...
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altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiration date not provided), via an unspecified route of administration left arm first dose on 08Jan2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient got the first shot of the Pfizer Covid 19 vaccine last Friday 08Jan2021. Stated that she had normal slight arm soreness and slight headache on Saturday 09Jan2021. Stated that she woke up this morning 11Jan2021 and had altered taste and sense of smell. Stated that she has not heard of this as reaction to the shot. Stated that she feels fine. Stated that she put on perfume that was old and fixed grits with cheese which she could barely taste. Stated that she tried other things and noticed that she has altered sense of taste and smell. The patient did not received treatments for the events. The outcome of the events slight left arm soreness and slight headache was recovered on 09Jan2021 and not recovered for the other events.
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| 75 | 2021-01-19 | flushing |
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbea...
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Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
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| 75 | 2021-01-20 | flushing |
5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throa...
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5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throat, HA, B/P170 (never this high); eyesight blurred. Systemic w/o urticaria
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| 75 | 2021-01-20 | grand mal seizure |
Grand Mal Seizure lasting about 10 seconds. Recovered without sequela. No h/o any seizures prior to...
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Grand Mal Seizure lasting about 10 seconds. Recovered without sequela. No h/o any seizures prior to vaccine.
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| 75 | 2021-01-20 | weakness |
Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consu...
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Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) at single dose for COVID-19 immunization on 09Jan2021. Relevant history included High blood pressure. Relevant concomitant drugs included Losartan for Blood pressure high, and hydrochlorothiazide. The patient had the first Covid 19 Vaccine on 09Jan2021 and she knew little bit dizziness was normal but she had a nose bleed in the next morning that she could hardly stop, she finally got it stopped it, it left she little weak so she just wanted to report that, she did not know if anyone had ever had that before (Hence, MI was made). Outcome of event Nose bleed was recovered, the outcome of other event was unknown.
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| 75 | 2021-01-20 | tingling | Systemic: Tingling in the fingers on the same arm of injection site-Mild |
| 75 | 2021-01-21 | pain in extremity |
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B...
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Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
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| 75 | 2021-01-24 | pain in extremity |
1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , ...
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1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , lesion on gum
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| 75 | 2021-01-24 | pain in extremity |
I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left...
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I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left arm, I couldn't sleep on my left arm due to this soreness. This started the day the soreness started. The following day and up till now I felt very tired and like I needed to take a nap. Due to work I have not been able to nap. On Sunday I noticed I had a fever blister on the right side of face, under my lip by my chin. It looked like a herpes blister. I rarely get them unless there is a serious stressor to my body or if my body is emotionally stressed. Valacyclozir I took 4 of those in the morning and 4 tablets in the evening after noticing them. I put a cream on the blister. On Tuesday or Wednesday 3 or 4 days after the vaccine I felt a pain in my gum by back two teeth, the gums were very painful when I brushed my teeth or put my tongue on it. I went to the dentist Friday the 22nd, however the dentist said it was intraoral herpes that he believes it is looked to the vaccine. Dr. believes the COVID vaccine activated the dormant herpes in my system . He said says it is located over the Greater Palatine Foramen. The herpes on my chin went away. I still feel light sensitivity and fatigued. Dr recommended to see my dermatologist. Either the 22nd or 23rd I had a virutal appointment with my dermatologist. She recommended I take 4 Valacyclozir in the AM and PM. And then 1 day for 10 days. Both doctors recommended not getting the 2nd dose until the herpes vaccine goes away. Once it goes away they suggested taking the Valacyclozir before taking the 2nd dose. I am still not feeling normal. My dentist said he was going to consult a group of dentists to see if any other dentists have seen the correlation between the COVID vaccine and activating the herpes virus. I plan to consult my PCP about if I should delay the 2nd dose.
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| 75 | 2021-01-24 | tremor |
Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. ...
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Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. 4:06 PM vitals 209/88 P 94 sao2 99%. Pulse increased to 110 at 4:10 PM. Patient transferred to urgent care via w/c. Patient checked and left with nursing staff for evaluation.
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| 75 | 2021-01-25 | numbness |
16:45 reports (L) arm numbness starting @ (L) shoulder extending to (L) hand. EMS notified for evalu...
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16:45 reports (L) arm numbness starting @ (L) shoulder extending to (L) hand. EMS notified for evaluation. B/P 190/102. P73, Glucose 109 (2° post prandial) O2 sat 100% Pt. refused transport to local hospital.
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| 75 | 2021-01-25 | feeling hot |
C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (...
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C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (1:1000 aq) 0.5ml). No improvement and transported via ambulance to ER. Contacted by RN later and reports treated and released at ER.
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| 75 | 2021-01-25 | tingling | Facial tingling BP 160/90 HR 85 Resp 18 trelegy prednisone ventolin |
| 75 | 2021-01-25 | feeling hot | Tingling in tongue and heat tongue. No v/s provided |
| 75 | 2021-01-26 | feeling cold, cold sweat |
On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated...
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On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated, and said she couldn't sit up. She called her husband to come and pick her up. She was afebrile. Blood sugar was 86. She said she just wanted to sleep. She sleep most of the day and through the night until 3:30 am today. She woke up and said she feels fine. She said at one point her body felt frozen and she couldn't move at all.
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| 75 | 2021-01-26 | tingling |
Pt developed left lower lip paresthesia that radiated to L side of face. 911 transfer recommended to...
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Pt developed left lower lip paresthesia that radiated to L side of face. 911 transfer recommended to which patient declined. Pt has history of TIA, Stroke, CKD, on gabapentin for facial nerve pain.
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| 75 | 2021-01-27 | feeling cold |
Dizziness; history included compromised immune status; history included compromised immune status; g...
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Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
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| 75 | 2021-01-28 | weakness |
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil...
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Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
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| 75 | 2021-01-30 | facial paralysis | Rt facial swelling and drooping |
| 75 | 2021-01-31 | weakness |
rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak...
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rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
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| 75 | 2021-02-01 | flushing, feeling hot |
Pfizer-BioNTech COVID-19 Vaccine EUA. 1.5 hours after receiving vaccine (12pm), I felt a flush/war...
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Pfizer-BioNTech COVID-19 Vaccine EUA. 1.5 hours after receiving vaccine (12pm), I felt a flush/warm sensation in my heart area. My heart rate increased, jumping around a lot. I could see my chest moving up & down. I tried to monitor BP & heart rate w/my heart monitor. BP was up to 154/103, pulse 73 at 12:20; BP 150/92, pulse 70 at 1:00pm. My normal pulse is 50-55. Twice the monitor read ERROR. By 1:30 BP was 128/75, pulse 61 and I felt heart was more calm. By 10:30pm BP was normal, 116/74, pulse 52. By chance I had appointment with my cardiologist the next day, 1/25/2021. He said it was an episode of atrial fibrillation. I have not had that rapid heart rate issue since the stent implant in December 2011.
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| 75 | 2021-02-02 | seizure |
Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Nev...
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Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar.; This is a spontaneous report from a contactable Physician. A 75-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 18Jan2021 19:30 at single dose on left arm for COVID-19 immunization. Medical history included Stroke, diabetes, hypertension, anaphylaxis to bee stings. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sitagliptin phosphate (JANUVIA), hydrochlorothiazide, telmisartan, rivaroxaban (XARELTO), gabapentin and baclofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to Morphine and experienced Hives. Approximately 22 hours after vaccination the patient had a seizure on 19Jan2021 17:15. She felt fine up until the seizure occurred. She never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar. No treatment was received for the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolved. Information on the lot/Batch number has been requested.; Sender's Comments: Based on the time association and previously allergic reactions to bee stings and other drugs, the possible contribution of suspect BNT162B2 to the event seizure cannot be excluded in this elderly patient with multiple medical histories including stroke, diabetes and hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-02-03 | flushing |
Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had f...
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Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had facial flushing with a blood pressure reportedly at 212/90. However, a second opinion from another doctor stated they were unsure if true anaphylaxis. Epi pen was administered LOT 0FM498 and patient left in ambulance to go to ER.
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| 75 | 2021-02-03 | weakness | Flu like symptons, aches, weakness,chills |
| 75 | 2021-02-03 | seizure | Patient had seizure |
| 75 | 2021-02-04 | flushing |
Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Approximately 50 mins after va...
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Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Approximately 50 mins after vaccination, pt reports transient sensation of something coming over her, dizziness and short period of tongue swelling, SOB and facial flushing. Pt taken to the ED. Prednisone 40mg po at 1312 and discharge prescription for prednisone 40mg daily x 3 days.
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| 75 | 2021-02-04 | pain in extremity |
severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-yea...
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severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 09:45 at single dose for Covid-19 immunization. Medical history included high blood pressure; thyroid disease; high cholesterol; prior stroke; prior to vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe arm pain and fever on 20Jan2021 14:30. No treatment received for the adverse events. This is a non-serious report. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.
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| 75 | 2021-02-04 | weakness |
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes...
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severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
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| 75 | 2021-02-05 | pain in extremity | Sore arm 2 hours after shot. Took tylenol, went away. |
| 75 | 2021-02-06 | bell's palsy, face paralysis |
Vaccine given 1/13; symptoms began 1/21-burning and intermittent blurry eyes/double vision, drooping...
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Vaccine given 1/13; symptoms began 1/21-burning and intermittent blurry eyes/double vision, drooping left eyelid, drooping left side of mouth, fatigue; went to ER on 1/22, blood work, EKG, MRI normal, ER MD didn't know the cause but if symptions persisted, go to internal medicine MD; symptoms improved but saw Dr. on 1/28. She referred me to a neurologist. By 1/31, most of my symptoms had cleared. On 2/4, neurologist exam showed weakness in facial muscles, diagnosed condition as viral Bell's Palsy. Following medical exams, I read CDC report which referenced Bell's Palsy in Unsolicited Adverse Events section. Am sending this report
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| 75 | 2021-02-07 | flushing |
At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left side...
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At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left sided neck pain, flush, and sudden left sided headache. Staff was notified EMS crew immediately. B/P 151/83, Also diapheretic. Patient reported not feeling well at all and would like to go to the hospital. Transported to local hospital. for evaluation
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| 75 | 2021-02-07 | weakness |
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ...
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accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
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| 75 | 2021-02-08 | numbness |
Numbness in lower extremities, not able to walk independently, headaches, dizziness, hypertensive, s...
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Numbness in lower extremities, not able to walk independently, headaches, dizziness, hypertensive, sleeping 16+hours a day, and poor to no reflexes.
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| 75 | 2021-02-08 | pain in extremity |
her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke bet...
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her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later.
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| 75 | 2021-02-09 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that ...
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Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for Covid-19 immunization. The vaccine was administered at a nursing home. Medical history included dementia, hyperlipidemia, hypothyroid, and drug allergy to penicillin; all from an unknown date. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took iodine and experienced drug allergy. The patient experienced bell's palsy on 15Jan2021. The reported event was resulted in Emergency room/department or urgent care. No treatment was provided for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-02-09 | flushing |
Deep red Flush Began in cheeks And spread down to jaw line; This is a spontaneous report from a cont...
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Deep red Flush Began in cheeks And spread down to jaw line; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at Left arm on 25Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history included Penicillin allergy, no other medical history. Concomitant medication included simvastatin. The patient was not pregnant. The patient developed a deep red flush that started in her cheeks and went down to her jaw line on 25Jan2021 on 14:00. Stated that flush seemed to be abating but if it came back and/or other reactions occur she could go to Emergency Room. She had electrical shocks going down her left side. Stated that she read through everything on fact sheet but did not see that a flush might occur, it had been 8 hours. This was her first shot, had an appointment for three weeks for her second shot. No COVID prior to vaccination, no COVID tested post vaccination. The outcome of the event was recovering.
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| 75 | 2021-02-09 | pain in extremity |
Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 7...
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Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 75-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), intramuscular on 02Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was calling about the Covid-19 vaccine and reported that she had the 2 shots. She said that after both shots, her arm hurt, she felt wiped out, and she had joint pain. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The patient said that after the first vaccine, she had not had knee surgery, but before the second the second vaccine she had knee surgery. The patient clarified that it was a knee replacement on 12Jan2021. The outcome of the events was unknown.
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| 75 | 2021-02-09 | pain in extremity, discomfort |
Shot was painful. I told the assistant I had never had a shot that hurt that badly. She didn't ev...
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Shot was painful. I told the assistant I had never had a shot that hurt that badly. She didn't even acknowledge. After waiting 15 minutes I left with some discomfort but figured my arm will probably be sore for a few days. A couple hours after getting the injection, I couldn't move my left arm without excruciating pain. I'm only assuming she gave me the shot to close to the shoulder joint. It's now Tuesday, February 10, and it is improving with more mobility and not as painful. But, still hurts. Cannot sleep on my left side. I'm concerned about getting the second dosage on February 27 and if this has caused any damage to the joint. So far, I have not seen this side affect listed in any Covid fact sheets.
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| 75 | 2021-02-09 | pain in extremity |
Slight soreness in arm; This is a spontaneous report from a contactable consumer reporting for herse...
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Slight soreness in arm; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 22Jan2021 14:45 at single dose for covid-19 immunisation. Medical history included breast cancer from 2016 to 2016. The patient's concomitant medications were not reported. The patient experienced Slight soreness in arm. Outcome of event was unknown.
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| 75 | 2021-02-09 | pain in extremity |
Work up with a headache and sore arm and fatigue. Took 2 Tyneol, which helped. Later in mid mornin...
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Work up with a headache and sore arm and fatigue. Took 2 Tyneol, which helped. Later in mid morning started getting the chills which lasted until 8:00 p.m. on the same day. Am fine now.
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| 75 | 2021-02-09 | pain in extremity |
felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a cont...
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felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) intramuscular, on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 75 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 02Jan2021 at single dose. Relevant medical history included COVID-19 last Mar2020 and knee replacement on 12Jan2021. The patient received no concomitant medications. The patient reported she had the 2 shots. After both shots, her arm hurt, she felt wiped out, and she had joint pain. After the second shot, she did run a fever as high as 100. She said that she had the second shot on Friday 22Jan2021 and on Saturday she was wiped out. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The event wiped out had resolved in Jan2021, while outcome of other events was unknown.
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| 75 | 2021-02-10 | tremor |
On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. ...
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On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. Difficulty breathing; A fast heartbeat(90); Dizziness; Chills; Uncontrollable shaking for over an hour. Rash on face for less than an hour Starting on day 11: Blood pressure gradually reduced to my normal level over days Headache continued for several days
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| 75 | 2021-02-10 | weakness | Patient became weak, had the chills, and spiked a fever. |
| 75 | 2021-02-10 | weakness | Severe chills, temperature 101, severe headaches, thirst, weakness, body aches , insomnia |
| 75 | 2021-02-10 | weakness |
muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so s...
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muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so sick.; Slight headache like a little pressure on her head / Horrible headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL9262 (the patient was not sure of the second letter), via an unspecified route of administration in left arm on 23Jan2021 at 16:15 at single dose for COVID-19 immunization. Medical history included sinus infection. The patient was not pregnant at the time of vaccination. Facility where the COVID-19 vaccine was administered was Hospital. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included amoxicillin, clavulanic acid (AUGMENTINE) for sinus infection and pravastatin. The patient stated that when she went home after vaccination, she had a slight headache, like a little pressure on her head when she went to bed but that was supposed to be normal. So, she went to sleep and the next morning she woke up and she had every single side effects: the nausea was horrible, she must have thrown up 15 times, she had diarrhea and joint pain. She did not think she had any fever but she did had chills and muscle pain, weakness and had horrible headache. The events onset date was reported as 24Jan2021 at 12:00 AM (except for headache which started on 23Jan2021). No treatment was administered for these events. The patient stated that it scared her that she was so sick. All the reported events were assessed as non-serious. The patient reported that 3 days later she was still feeling very weak. At the time of the report the events headache, muscle aches, nausea, vomiting and chills had recovered with sequelae, the event weakness had not yet resolved, whereas the outcome of the events diarrhea, joint pain and sickness was unknown.
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| 75 | 2021-02-10 | tingling, numbness |
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not i...
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tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-02-11 | weakness |
Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next...
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Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)
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| 75 | 2021-02-11 | weakness |
On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed ...
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On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.
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| 75 | 2021-02-11 | burning sensation | PT C/O BURNING FROM CHEST UP, TACHYCARDIC, AND HYPERTENSIVE. SENSATION RELIEVED W/ BENEDRYL |
| 75 | 2021-02-13 | tingling, numbness, sensory loss |
Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert w...
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Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg.
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| 75 | 2021-02-14 | flushing |
patient became flushed, lightheaded and felt rapid heart rate 15 minutes after receiving vaccine. no...
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patient became flushed, lightheaded and felt rapid heart rate 15 minutes after receiving vaccine. no shortness of breath, no rash or hives.
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| 75 | 2021-02-14 | difficulty speaking, weakness |
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just k...
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sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient). This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
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| 75 | 2021-02-15 | pain in extremity |
Profound fatigue and generalized soreness most severe on days 2 and 3 after vaccination, but lasting...
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Profound fatigue and generalized soreness most severe on days 2 and 3 after vaccination, but lasting seven days. No fever or chills. Arm sore, warm and swollen, but not red. It is the severity of the reaction and its duration that prompts this submission.
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| 75 | 2021-02-15 | numbness, pain in extremity | Swollen tongue, swollen and numb left arm, pain in arm, pain behind ear. |
| 75 | 2021-02-16 | bell's palsy |
Diagnosed with Bell's Palsy 2 wks after vaccination. But I must also admit to having a cold sore ab...
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Diagnosed with Bell's Palsy 2 wks after vaccination. But I must also admit to having a cold sore about a week before the vaccination. I feel it is necessary to report both factors for accuracy.
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| 75 | 2021-02-18 | flushing |
Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled s...
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Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled second vaccine dose.
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| 75 | 2021-02-18 | feeling hot, flushing, tingling, tremor |
Patient described feeling of warmth, facial flushing, tremors, nausea, tingling in roof of mouth and...
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Patient described feeling of warmth, facial flushing, tremors, nausea, tingling in roof of mouth and hands 30 minutes following vaccine.
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| 75 | 2021-02-18 | hot flush, flushing |
ten minutes after I got the vaccine they had me sit and wait and I got a hot flush on my chest and ...
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ten minutes after I got the vaccine they had me sit and wait and I got a hot flush on my chest and neck. I felt dizzy, light headed. my heart was pounding. nurse came and checked my blood pressure it was 186/86. normal BP is 120-130. she took it again 10 minutes later and it was 170. the whole attack lasted about 25 minutes.
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| 75 | 2021-02-19 | pain in extremity |
Pain in left mid-thigh, and pain in left lower back pelvic area. Taking Advil during past four days...
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Pain in left mid-thigh, and pain in left lower back pelvic area. Taking Advil during past four days. Appointment with orthopedist is scheduled for 02/22/2021.
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| 75 | 2021-02-21 | pain in extremity |
Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfize...
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Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfizer) administration. Patient has documented history of anaphylaxis with IV contrast. EMS on-site provided cardiac monitoring. Observed elevated BP.
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| 75 | 2021-02-21 | tremor |
Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at...
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Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at 3pm
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| 75 | 2021-02-21 | pain in extremity, weakness | Sore arm; Temp of 100 for 2 days; general aches; fatigue; zero energy; headache on day 3 |
| 75 | 2021-02-21 | tremor, flushing |
flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent...
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flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent to ED for evaluation and montioring. BP 141/76 HR 84 02 97
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| 75 | 2021-02-22 | discomfort |
Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed s...
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Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed severe generalized weakness. She was unable to walk or stand. She laid on the floor from 2/21 3pm until 2/22 PM. She was incontinent of urine- reports urinating on towels throughout yesterday. She was unable to hold her head up due to weakness. She still feels weak today, but is able to stand and walk with husband's assistance. Also reports generalized muscle soreness and intermittent vertigo. She is drinking fluids well, has eaten a light meal today. Denies fever, shortness of breath, chest pain, palpitations.
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| 75 | 2021-02-22 | tremor | Severe shakiness - muscle weakness in legs Symptoms still persist today |
| 75 | 2021-02-23 | pain in extremity |
2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging...
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2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging, itchy, and noted right above the swollen are three red areas size of tip of my pinky. (these redish spots same on my first vaccination). A few hours after I took my temp and was 99.1. I double checked and 99.1. I took one Motrin for fever and couple hours no fever. Today 2/24= Lump swelling decreased and warm to touch. I have been applying Hydrocortisone Cream 1% for mild itching.
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| 75 | 2021-02-23 | weakness, facial paralysis |
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of a...
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Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
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| 75 | 2021-02-23 | night sweats |
Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with tem...
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Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with temp. up to 101.8. Day temps 99 to 100. Have lasted to the present time. Treatment fluids and aspirin. Chest x-ray and urinalysis clear. Covid nasal test yesterday, Feb.23. The second Pfizer vaccine scheduled for today, Feb. 24, was cancelled.
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| 75 | 2021-02-23 | pain in extremity |
Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes. Her a...
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Got the vaccine, and on 2/22/21 she woke up at 2-3:00 AM with violent vomiting, two episodes. Her arm was sore, still having nausea. She feels like she is going to throw up still, 2/24/21. She has not taken anything for the symptoms.
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| 75 | 2021-02-24 | tremor |
Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: redu...
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Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: reduction in flu like symptoms but disoriented and lethargy and headache Day 5: disoriented and lethary Day 6: same Day 7: shakey and lethargic Day 8: same
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| 75 | 2021-02-24 | burning sensation |
VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccinat...
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VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccination. Observed for an extra 15 min. vitals stable. symptoms subsided within 5 min of onset
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| 75 | 2021-02-25 | weakness |
Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started hav...
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Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast. On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure. Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam). Symptoms appear to be improved.
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| 75 | 2021-02-25 | tremor, weakness |
Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sin...
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Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sinuses, red burning eyes, constant sneezing and dripping nose, weak and shaky on my feet. Lose of appetite, constipation and nausea.. It lasted for 4 days and on Wednesday I called my medical care giver and she said that I probably had an allergic reaction to the vaccine and to not take the next dose, as this had been my first. I am still, periodically week and dizzy, and still have little appetite.
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| 75 | 2021-02-27 | nerve pain |
Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injec...
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Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injection sight up to my ear and neck. The pain in my neck stayed for 9 days with pain to my arm that was terribly painfull. Now I still have an ache in my neck and arm that is mild but also feels very tired like if you had a neck injury from nerve pain
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| 75 | 2021-02-27 | flushing |
Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feel...
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Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feeling pressure in the head I have observed Patient having red face itchy face foggy pressure in the head. Vital signs: 0843 BP 170/80 HR 96 RR 18 Pulse Ox 98% 0846 BP 182/80 0857 BP 168/84 HR 88 RR 16 Pulse Ox 97% 0910 BP 180/90 HR 88 RR 16 Pulse Ox 97% 0925 BP 200/90 HR 88 RR 16 Pulse Ox 97% Treatment/intervention Monitored offered water Benadryl 25 mg po @ 0850 by an RN, Benadryl 25 mg po @ 0914 by an RN 0925 patients BP continued to be out of normal range patient stated that she took her BP medications this am. Face still flushed. 0925 ambulance called to transport patient to the ED. 0925 ambulance her report given.
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| 75 | 2021-02-27 | numbness, night sweats, weakness, tingling, burning sensation |
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of ...
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Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness, dry mouth, joint pain, headache,...
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| 75 | 2021-02-28 | feeling cold |
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a ...
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On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
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| 75 | 2021-02-28 | tingling |
Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower li...
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Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower lip paresthesia that radiated to L side of face.; This is a spontaneous report from a non-contactable pharmacist. A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular on 26Jan2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included transient ischaemic attack (TIA), stroke and chronic kidney disease (CKD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gabapentin for facial nerve pain. The patient developed left lower lip paresthesia that radiated to the left (L) side of face on 26Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-02-28 | pain in extremity, muscle spasms |
Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two d...
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Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two days after receiving the Covid19 vaccine. Great difficulty walking. without assistance. Pain began to subside on the fourth day and is less intense today, the fifth day following vaccination but is still present.
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| 75 | 2021-03-01 | discomfort |
Same day -fatigue, slept for 4 hrs. 4pm to 8pm. Increasing generalized pain, fatigue, and discomfort...
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Same day -fatigue, slept for 4 hrs. 4pm to 8pm. Increasing generalized pain, fatigue, and discomfort first night, through next day. 101 fever. Severe flu symptoms. Started to abate on Wednesday.
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| 75 | 2021-03-01 | weakness | Sever pain in arm at injection site. Also nausea & weakness. |
| 75 | 2021-03-01 | weakness |
Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "coul...
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Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "couldn't swallow." The symptoms "wouldn't let up" then patient reports by Saturday Feb 20, she felt "washed out," couldn't breathe, lost all energy, and had a RA attack. Her knees are still throbbing today.
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| 75 | 2021-03-01 | numbness |
Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from h...
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Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at 13:00 at single dose into right arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL8982. Medical history was unknown and concomitant medications included blood pressure pills and cholesterol pills and vitamins. On 24Jan2021, the patient experienced transverse myelitis; the patient was hospitalized due to the event (hospitalization dates from 24Jan2021 to 7Feb2021; emergency room since 24Jan20211 noon). Consumer stated that when she was in the hospital, she was on heavy doses of steroids intravenous (IV) for 5 days. Blood work at the hospital was normal. Consumer left the hospital to go to the rehab facility on 30Jan2021, and then consumer left the rehab facility on 07Feb2021. Consumer stated that she could not walk. Consumer had complete numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side. Consumer stated that she was still having issues with dragging her left leg, and with rehab, she was finally getting back some feeling, the numbness was still there but she was having bowel and urine issues. Consumer stated that her issues have somewhat improved with the help of rehab. The patient was recovering from the events.
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| 75 | 2021-03-01 | difficulty speaking |
itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Pr...
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itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Progressively worse in order listed over 10 minutes. Chewable benadryl 12.5 mg x 4 given. Pt reported improved symptoms within 10 minutes and was asymptomatic at 30 minutes.
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| 75 | 2021-03-02 | tingling |
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie...
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AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
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| 75 | 2021-03-02 | weakness |
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This ...
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Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
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| 75 | 2021-03-02 | feeling jittery |
Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had g...
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Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had generalized itchy fore head ,bilateral eyes, throat and ears. Vital signs within normal. Patient was placed in recumbent position and was given apple juice. Patient stated all symptoms resolved at1312 and was discharged home.
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| 75 | 2021-03-02 | flushing |
Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Sp...
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Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Spontaneous improvement. No medications offered.
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| 75 | 2021-03-03 | bell's palsy | Bells Palsy-treated with Prednisone |
| 75 | 2021-03-03 | tingling |
Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased ...
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Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased work of breathing. Pt. also complained of tingling in bilateral lower extremities. Pt. also noted with hypertension and bradycardia (beta blocker therapy). She was given Zyrtec 10mg po without resolution of symptoms within 30 minutes. Pt. then received IM Epi-Pen. Pt. remained alert and appropriate with on-going SOB when EMS arrived to transport to local ED. Medical response was activated for this event.
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| 75 | 2021-03-04 | weakness |
My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe head...
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My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep. Day two the chills were gone but still very achey, weak, tired and headache. Day three she is still tired and weak with headache.
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| 75 | 2021-03-04 | weakness |
Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednes...
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Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednesday following the vaccine.
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| 75 | 2021-03-04 | seizure |
Patient's son reported that patient had a seizure on 3/5/21 after receiving the second Pfizer-BioNTe...
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Patient's son reported that patient had a seizure on 3/5/21 after receiving the second Pfizer-BioNTech vaccine on 2/24/21.
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| 75 | 2021-03-04 | tremor |
chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well...
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chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well . This lasted a day, feel better today
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| 75 | 2021-03-05 | weakness |
Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days...
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Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days before increased, Could hardly move, shortness of breath , had to stop constantly to get down the slopes to condo, very weak, laid down on bed, had chills and sweats off and on, felt achy all over - could hardly move around - in other words had symptoms of Covid 19 slept overnight. The next morning was much better although still a bit tired. It was very scary but I realized that it was a reaction to the vaccination.
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| 75 | 2021-03-07 | pain in extremity |
After 5 days of the injection (2/22/21) had sore arm and then pain in the muscle and also the joint ...
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After 5 days of the injection (2/22/21) had sore arm and then pain in the muscle and also the joint of her shoulder. She has a sharp pain when she moves her arm in certain positions,. Goes from a muscle soreness to a sharp stabbing pain. She went to her doctor and he said that it was from the vaccine and not her rheumatoid arthritis.
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| 75 | 2021-03-07 | pain in extremity |
At 12:30a.m. I awoke after the shot to shooting pain on the left side of my head that would last for...
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At 12:30a.m. I awoke after the shot to shooting pain on the left side of my head that would last for seconds and continue every few minutes. My arm was hurting a lot also, but I expected that. I took an Ibuprophen but it continued now coming every 10 minutes. My son told me to take 3 ibuprofen at a time every 4 hours that allowed me to go back to sleep. When I awoke I continued the ibuprofen but in the afternoon I was getting the shooting pains in my left ear. SO I continued the ibuprofen. On Sunday m72 hours after the shot my arm was so swollen and red with pain and itching. I called my doctor and she said to take ibuprofen and come in if it is not better on Monday.
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| 75 | 2021-03-07 | cold sweat |
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;...
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Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
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| 75 | 2021-03-07 | tremor |
Had felt chilled most of the day and around 8:30 the chills became extreme. Also felt feverish and ...
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Had felt chilled most of the day and around 8:30 the chills became extreme. Also felt feverish and slight headache. Was shaking badly. Took an excederin and got in bed. In about one hour, the symptoms stopped and I began to feel better. I drank a whole bottle of water as I felt dehydrated. Slept through the night and was ok the next day.
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| 75 | 2021-03-08 | muscle spasms |
Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a con...
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Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a contactable consumer (patient). A 75 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265), via an unspecified route of administration (on right arm) on 30Jan2021 12:30 (at the age of 75 -years-old), single dose for COVID-19 immunization. Concomitant medication included levothyroxine sodium (L THYROXINE), rosuvastatin, magnesium. Back pain, extremely painful back muscle spasms. Started minor pain 3 days after vaccine didn't associate it with vaccination, very painful and spasms on day 6. Have not had any back injury or strain that patient was aware of. It was reported that adverse events started 04Feb2021 19:00. Patient just wanted to be sure if ok to take 2nd vaccination. The outcome of the events was not recovered. No treatment given for any of the adverse events. The events were assessed as non-serious by the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 75 | 2021-03-08 | tremor, weakness |
Pt shaking, tremulous, weak. VSS. symptoms improved with juice. pt reports feels well and would like...
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Pt shaking, tremulous, weak. VSS. symptoms improved with juice. pt reports feels well and would like to go home.
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| 75 | 2021-03-08 | pain in extremity |
arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist wa...
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arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; light headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 26Jan2021 at 10:40 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included arthritis from an unknown date, renal cancer since 07Dec2020 and ongoing, atrial fibrillation since 2006 and ongoing, partial nephrectomy on 06 Jan2021. She specified that she has an arthritis flare up about once a year and normally takes a Medrol dose pack. The patient's historical vaccines included an unspecified flu vaccine (MANUFACTURER UNKNOWN) on an unspecified date about ten years ago after which she had to go to the Emergency Room for right arm redness, swelling at the injection site and face swelling on right side. She did not get another flu shot for 10 years but did get one this year in Nov2020. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), flecainide acetate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN, MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that she experienced a light headache. She clarified that she is in an unspecified program which includes an e-diary. As part of that program (app) she was sent a text every day for a week asking if she had any side effects; a couple times she had a headache. On the eighth day (03Feb2021) she had a reaction where her right hand and wrist was painful and swollen. Caller states she couldn't move her hand without pain. Caller states she put ice on her hand Wednesday evening and this helped a little. When ice was on her hand it helped with the pain but when it was removed it came back. She also reported fingers on right were all swollen and that she does have arthritis. She further described the events as on Wednesday she started getting a little pain in her right wrist joint. She does have arthritis, but this pain was stronger, and her hand and fingers on right were all swollen in comparison to her other hand, and her knuckles seemed bigger. States that the pain got very strong and by the next morning she could barely move her arm; even though it was only her wrist that hurt, moving any part of her arm made her wrist her more, so she started icing it and took Tylenol for Arthritis 650mg Extended Release; she took it twice, one each time and reported that it probably didn't work. Caller clarifies statement about it probably not working; stating that she didn't notice a difference after taking the Tylenol. She asked if these events, occurring eight days after the vaccine could be vaccine side effects or is this just a flare up on her arthritis that is unrelated to the vaccine. She added that she had been doing a lot of "chopping" while cooking on the night that this happened so that may have caused the flare up. She has a Medrol pack on hand for things like this (4mg tablets). She started it today and took two tablets before breakfast and one tablet at lunch. She states that it has already made a difference in her pain. She stated her concern, however, which is that she found that taking a steroid could affect the vaccine if taken before getting the vaccine, and right now she is in-between the two doses. Her second dose is scheduled for 16Feb2021. She inquired as to if she can finish this dose pack without messing up the vaccine. The clinical outcome of headache was reported as recovered. The clinical outcomes of hand swelling, wrist pain, hand pain and swelling of wrists were reported as not recovered. The clinical outcomes of arthritis flare up, swelling of fingers and could not move her arm were unknown.
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| 75 | 2021-03-09 | pain in extremity |
Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She cou...
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Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She could not dress b/c the feeling of clothing in arm was excruciating.; This is a spontaneous report from a consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 02Feb2021 08:00 at single dose for covid-19 vaccine. Medical history included diabetes and hypertension. Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had severe arm pain going down to hands and fingers on 02Feb2021 at 18:00. She had severe sensitivity. She could sleep due to pain but could not unfold elbow or arm due to pain. She could not dress b/c the feeling of clothing in arm was excruciating. She was in tears. It was been about 5 days and the pain and sensitivity has increased every day. Patient had taken paracetamol (Tylenol), ibuprofen (Advil) went to my primary and got prescribed tramadol for pain. Nothing was helping. Patient visited doctor or other healthcare professional office/clinic visit due to events. She did not have COVID tested post vaccination. The outcome of events was not recovered. Information on batch number has been requested.
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| 75 | 2021-03-11 | breast pain |
I received my first Pfiser on January 29, 23021 I received my second Pfiser on February 17, 2021 Bot...
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I received my first Pfiser on January 29, 23021 I received my second Pfiser on February 17, 2021 Both were administered at clinic. Second vaccination was administered on a Wednesday. By Friday I was in terrible pain on my left breast. On Sunday I was admitted to hospital with a terrible infection. The infection could not be gotten under control with antibiotics which resulted in my having my breast implant removed. I was hospitalized for three days. The Implant had been in since July 2020. I had been healthy without any change in my life style, etc. until the vaccination. Therefore, the infection appears to be a result of the vaccination.
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| 75 | 2021-03-11 | weakness | Nausea, vomiting, fever, generalize weakness, dehydration |
| 75 | 2021-03-13 | weakness |
1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, ...
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1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, injection site got red, swollen, had hard knot, and deep itch at injection site right arm. On third day started getting brain fog, had hard time concentrating and felt extremely tired. Redness, swelling, hard knot, and deep itching has gone away. Still have a bit of brain fog but getting better. Knee joints are hurting. I got most of my energy back. It took 9 days for redness and swelling to go down. I did not seek treatment for symptoms.
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| 75 | 2021-03-13 | pain in extremity |
Gastric distress 1 hour after first shot; Slight headache, Gastric distress for 5 days. After seco...
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Gastric distress 1 hour after first shot; Slight headache, Gastric distress for 5 days. After second shot,: Sore arm, slight headache, extreme fatigue on the second day, some fatigue on the third day. Two weeks after the vaccination : no issues
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| 75 | 2021-03-14 | pain in extremity |
A sore arm/just kind of sore; This is a spontaneous report from a contactable consumer. A 75-years-o...
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A sore arm/just kind of sore; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3247 with expiry date: 31May2021) via an unspecified route of administration on 28Jan2021 at single dose for Covid-19 immunization. The patient's medical history included high blood pressure which was well controlled, diabetes controlled upon her diet, due to arthritis she don't walk really fast and she has go to physical therapy for it. Consumer stated, well I got the first Pfizer vaccine (clarified as COVID 19 vaccine) on 28Jan2021. I got it and I am just fine I got it in (place name), then I noticed on here I had no awful side effect whatsoever, what was the likelihood with that of having the awful side effect with the second vaccine. When probed to clarify if experienced any side effect, Consumer stated, It was just kind of sore (sore arm) but nothing awful at all. She also stated she took second doe on 18Feb2021. Consumer further stated, I just wanted to know what are the chances were because one of my friend got the AstraZeneca and she didn't have it either any symptoms after the first injection but after the second one she did it was more likely to occur after the second vaccination. The outcome of event was unknown. No follow-up attempts are possible. No further information was provided.
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| 75 | 2021-03-14 | pain in extremity |
Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it fee...
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Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it feels like kind of sore when I touch it; She is getting red bumps today on the part where she got injected; Sore arm; I get this pain in my pointer finger in my right hand; A little weakness in my right leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 75-years-old) as a single dose for covid-19 immunisation. Medical history included high blood pressure, osteoporosis and overactive bladder. The patient concomitant medications were not reported. The previously had first dose (first shot) of BNT162B2 for covid-19 immunisation and had sore arm. It was reported that she is getting red bumps today (on 07Feb2021) on the part where she got injected. The consumer stated after second shot also, I had no symptoms except for sore arm on an unspecified date in Feb2021. The only thing that I noticed which was from second shot and which was really crazy is, once in a while I get this pain in my pointer finger in my right hand and that was it, it comes and it goes. But today, and in the last couple of days I noticed a little weakness in my right leg, but today when I went to work somebody said what is that big red bump on your forehead and I looked and there was a big red circle, there was a bump, like a real bump on my forehead. I didn't hide it, I didn't even think if it was allergic as I only had a banana before I went to work and a cup of coffee which I have lot of time. I am wondering if this bump that I have on my forehead which looks ridiculous and it is a big red bump, like a tumor bump, it feels like kind of sore when I touch it, is from the vaccine because I haven't had anything but the vaccine." Consumer stated, "Main thing I am concerned about is the big red bump on my forehead." Treatment: Consumer stated, "I never had that before, it is very slight. The main thing was the bump on my head that came today and I didn't have it when I left the house. I didn't hit my head or anything. I just took two Tylenol and an allergy pill in case if it was some kind of allergy." The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 75 | 2021-03-14 | pain in extremity | Severe pain and loss of mobility to injection arm |
| 75 | 2021-03-14 | pain in extremity, weakness |
Started out Friday, 3/12/21 around 2PM, headache, got worse as evening came, next morning, Saturday ...
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Started out Friday, 3/12/21 around 2PM, headache, got worse as evening came, next morning, Saturday 3/13/21, sore arm, head felt like someone stuffed it, afraid to take any medication or to eat anything. Felt like throwing up all day, but never did. Very tired all day, slept off and on half the day on the couch. Started to feel a little better around 8PM 3/13/21. Fever, usually my temperature is 97.7 or 97.8 but at one time it was 101. Very week and drained. Sunday 3/14/21, felt much better but head still hurt a little. Monday, 3/15/21 head hurt a little in the morning, but was okay by around 9AM. Pretty much back to normal after that.
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| 75 | 2021-03-15 | hot flush |
About 5 minutes after injection I had a wave of dizziness and hot flash which only lasted a few seco...
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About 5 minutes after injection I had a wave of dizziness and hot flash which only lasted a few seconds. I remained at the facility to make sure I was OK to drive. Later that evening until next day at noon I was slightly dizzy.
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| 75 | 2021-03-15 | hot flush |
After receiving her vaccine, client stated that she experienced hot flashed. Vital sighs obtained b...
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After receiving her vaccine, client stated that she experienced hot flashed. Vital sighs obtained by EMS. BP 99/62, 99%, HR 75. Client stated she feels better. Client discharged home.
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| 75 | 2021-03-16 | tingling |
Subacute onset of bilateral cervical neck pain radiating to left shoulder with paraesthesia and sens...
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Subacute onset of bilateral cervical neck pain radiating to left shoulder with paraesthesia and sensory neuropathy including burning pain not associated with activity, not ameliorated with rest, NSAIDs or Tylenol, not worsened with movement. No associated trauma, No constitutional Symptoms. Symptoms are most consistent with transverse myelitis
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| 75 | 2021-03-17 | facial pain, bell's palsy, facial paralysis |
Pain on left side of face, nasal cavities, mouth. Dull headache, fatigue The following morning when ...
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Pain on left side of face, nasal cavities, mouth. Dull headache, fatigue The following morning when I woke up the left side of my face was drooping especially in cheek and mouth areas
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| 75 | 2021-03-17 | pain in extremity |
Patient received her first dose of pfizer x 2 weeks ago Number of days post vaccine: 14 days Initia...
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Patient received her first dose of pfizer x 2 weeks ago Number of days post vaccine: 14 days Initial reaction was noted on day 2 after vaccine. Redness and pain to site resolved after a 3 days. Symptoms to arm has returned with an increase in pain to the right arm of 6/10 on a pain scale. Has been taking Tylenol and use of cold compresses without any effect. Reports of an induration, area red and warm to touch. Limited range of motion; able to move arm with pain but unable to lift any object.
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| 75 | 2021-03-18 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female...
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Sore arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), (at the age of 75-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure, osteoporosis, Overactive bladder. The patient received second shot on the 06Feb (not clarified). After the first shot, the patient had no symptoms except for sore arm. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 75 | 2021-03-18 | pain in extremity |
Soreness began five full days after injection in my left arm. Excruciating soreness starting from th...
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Soreness began five full days after injection in my left arm. Excruciating soreness starting from the base of my neck across the left shoulder down my upper arm to the elbow and below. It lasted for 7 days and then the soreness left as fast as it began.
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| 75 | 2021-03-18 | weakness |
Symptoms matched physical condition prior to medication for Parkinson's Disease and included; extrem...
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Symptoms matched physical condition prior to medication for Parkinson's Disease and included; extremity immobility and collapse, compromised ambulation, weakness and fatigue after limited exertion. The first day of incidence was on 3/15/2021 and was at the upper limit on 3/18/2021.
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| 75 | 2021-03-18 | pain in extremity |
Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This i...
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Unable to sleep; Gas from both ends; Stomach cramps; Constipation; Her injection arm is sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 11Feb2021 15:30 as single dose for COVID-19 immunisation (because of the pandemic and she is 75). Medical history included being diabetic. Concomitant medications included warfarin and varicella zoster vaccine taken for an unspecified indication, start and stop date were not reported. The patient previously had a flu shot back in Oct2020 and experienced sore at the injection site. The patient was unable to sleep last night due to stomach cramps and constipation. It has been horrible. Worst part was gas from both ends. The events began 9PM or a little earlier on 11Feb2021. The patient also reported that her injection arm was sore on Feb2021. This is the first time she has had a reaction like this and not been able to sleep. Asked if she should drink some lemon water, take a laxative, or what to do. Advised the patient to follow up with primary care physician for treatment recommendations. The patient underwent lab tests and procedures which included blood pressure: 124/78 and A1C: 5.9 on an unspecified date; international normalised ratio (INR): 424 on 08Feb2021. The outcome of the event her injection arm was sore was unknown and not recovered for the rest of the events.
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| 75 | 2021-03-19 | tingling |
Right shoulder pain with limited movement since her COVID vaccine 3 weeks ago. MRI - revealed a tend...
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Right shoulder pain with limited movement since her COVID vaccine 3 weeks ago. MRI - revealed a tendon tear -degenerative arthrosis- issues with rotator cuff Patient also has tingling in her fingers. Suspect SIRVA (Shoulder Injury received from vaccine administration) as an issue to her already present shoulder issues. Plays tennis frequently Spoke with patient and she is doing fine other than pain from the site
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| 75 | 2021-03-20 | flushing |
3 hours after injection, experienced pain and tenderness at injection site; facial flushing that per...
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3 hours after injection, experienced pain and tenderness at injection site; facial flushing that persisted for 3 days; This is a spontaneous report from a contactable 75-year-old non-pregnant female nurse (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 at 09:15 am at single dose for covid-19 immunization on left arm. The patient's medical history included hypothyroidism, breast cancer and known allergies: Shrimp, cilantro, contrast dye, gadolinium. Concomitant drugs included Levothyroxine sodium, ciclosporin (RESTASIS), multiple vitamins. On 05Feb2021, 3 hours after injection (12:00 PM), the patient experienced pain and tenderness at injection site, facial flushing that persisted for 3 days. Benadryl 25mg taken every 4 hours for 2 days for flushing. The laboratory test included temperature taken and WNL (within normal limits) 97.2 during flushing period. The outcome of the events was recovered. Information about Lot/Batch number is requested.
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| 75 | 2021-03-20 | pain in extremity |
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ...
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Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-03-20 | pain in extremity |
The day following my 2nd vaccine my arm started swelling and was red and painful. It has now been 4...
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The day following my 2nd vaccine my arm started swelling and was red and painful. It has now been 4 days and continues to get more redness and now itches. Taking Benadryl for itching.
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| 75 | 2021-03-21 | weakness |
Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chil...
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Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021
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| 75 | 2021-03-21 | pain in extremity |
My arm was sore that night. I couldnt breathe very well when I woke up. I put my protable O2 on and ...
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My arm was sore that night. I couldnt breathe very well when I woke up. I put my protable O2 on and I ate, took my meds and went back to bed. I took a rescue inhaler to see if it would help. I stayed in bed all day wednesday. I coughed all night, I am on O2 all night. I seem to be parched, mouth is dry, drinking a lot of water. Thursday was just as bad, I wasnt feeling well. the breathing gets better a little every day but I am coughing up green mucus so I called my pulmonologist and he called in an antibiotic.
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| 75 | 2021-03-21 | pain in extremity |
Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; ...
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Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; Tiny pimple-like bumps on entire scalp, very itchy; Fatigue; This is a spontaneous report from a contactable (consumer). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 00:45 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to penicillin and derivatives from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EL9262) in the left arm on 21Jan2021 at 10:15 (at the age of 75-years-old) as a single dose for COVID-19 immunization and experienced slight pain in left arm of injection site/sore. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that on 16Feb2021 at 16:00 she experienced slight pain in left arm of injection site, sore for 24hrs; tiny pimple-like bumps on entire scalp, further reported as very itchy; and fatigue which lasted 24hrs. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of slight pain in left arm of injection site/sore, tiny pimple-like bumps on entire scalp, very itchy, and fatigue were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 75 | 2021-03-22 | pain in extremity |
Arm got sore and soreness moved to clavicle area in about 2-3 days. Then, lymph nodes around clavica...
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Arm got sore and soreness moved to clavicle area in about 2-3 days. Then, lymph nodes around clavical area became swollen and stayed swollen for about 2 weeks but are getting better now. No treatment needed and did not go to MD. Note: vaccine could be lot EU6200 because not sure of writing.
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| 75 | 2021-03-22 | pain in extremity |
Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hive...
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Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hives on left side of neck (received shot in left arm) diarrhea all day after shot; arm slightly sore. Did not feel sick; just had these reactions.
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| 75 | 2021-03-23 | pain in extremity |
By the end of the next day, I started having shooting pains in my left arm when I moved it. I am st...
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By the end of the next day, I started having shooting pains in my left arm when I moved it. I am still having these pains. I have sharp pains when I raise my arm or move it back and forth. I am in physical therapy now.
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| 75 | 2021-03-23 | pain in extremity |
During the night about 12-14 hours after receiving the vaccine, I work up dreaming of people who wer...
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During the night about 12-14 hours after receiving the vaccine, I work up dreaming of people who were complete strangers and I knew nothing about what they were doing in the dream or why I was there. It made me wonder if the vaccine was having some effect on my brain. I also woke up at least 8 times during the same night with my mouth so dry it almost had no feeling in it. Neither of these events has ever happened to me before. I don't dream about strangers and I don't wake up so frequently needing water. So I don't know what to attribute it to except the vaccine since it was the only thing different. I had a sore arm with the first dose but that was all that happened.
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| 75 | 2021-03-23 | feeling cold |
adverse events: headache, body aches, chills, sore throat, fatigue treatment: rest, extra vitamin D...
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adverse events: headache, body aches, chills, sore throat, fatigue treatment: rest, extra vitamin D outcome: lasted approximately 48 hours
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| 75 | 2021-03-24 | weakness |
She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, an...
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She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better. About 12 hours later she had a headache and took some Aleve. She woke up the next morning with a severe headache and chest pain that was excruciating. Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis. They sent her home with steroids and Colchicine. They did not want to put her on NSAIDS due to possible ulcers. She all the COVID symptoms, and had severe pain still. Her daughter 3 weeks later took her to the cardiologist. She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine. She was then sent to the ER again, and went there twice. He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues. They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter. She is now back in sinus rhythm. She was advised not to get the 2nd vaccine due to the reactions from the first one. She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
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| 75 | 2021-03-24 | tingling |
Tingling in left cheek from chin to left eye. Numbness in left eye. Cannot wink left eye and no f...
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Tingling in left cheek from chin to left eye. Numbness in left eye. Cannot wink left eye and no feeling in it. Cannot feel coldness from eyedrops or feel the drop entering my eye. some feeling is returning but not all in the past few days. No facial drooping. This began either end of Feb or beg gining of March. Still have some tingling in cheek also.
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| 75 | 2021-03-25 | numbness, pain in extremity |
I developed pain and then numbness along distribution of my left lateral cutaneous femoral nerve ( p...
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I developed pain and then numbness along distribution of my left lateral cutaneous femoral nerve ( pain and numbness ofver atneriolateral aspect of my left thigh ). As of today 3/27/2012, numbness persists but pain seems to be decreasing.
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| 75 | 2021-03-26 | tremor |
Vaccine at 3pm, this happened at 11:00pm. So cold, I felt like my bones were in ice. My hands tremb...
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Vaccine at 3pm, this happened at 11:00pm. So cold, I felt like my bones were in ice. My hands trembled badly and my teeth chattered because I was so cold. Nothing got me warm. I had 5 heavy blankets on me, didnt help. I fell asleep and woke up at 3:00am and was back to normal.
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| 75 | 2021-03-28 | unresponsive to stimuli |
Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started b...
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Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started by family. Pt was in asystole, intubated, given two rounds of epinephrine in the field. Pt was on autopulse and ROSC was achieved around 0125. Pt was seen at ER and was transferred to Hospital.
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| 75 | 2021-03-30 | pain in extremity |
This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer...
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This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 05Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), depression, both hips replaced and allergic to sulfur. Concomitant medications included ibuprofen, blood pressure and depression pill. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization and experienced mild arm soreness. The patient received her second Pfizer COVID vaccine on 05Mar2021 at 1 PM. The following morning on 06Mar2021 she woke up at 6:30 AM with an itchy rash on her buttocks and hips. She took diphenhydramine (BENADRYL) and it subsided but came back later and started spreading to her thighs, chest, arms, stomach, and back. She was taking Benadryl to treat it and wanted to know what else to do. She was covered with a rash and itching and going crazy, they were welts like little welts kind of hives; It is itching all over; It didn't go away, it was itching all through the day. It just kept getting more and more in covers like her knees up to her butt, her butt was all covered, her lower back was covered and her arms were getting it now that just keep travelling. It is all around the area, it's travelling everywhere my legs, my arms and my chest. The patient had the 2nd dose yesterday (05Mar2021). She experienced little soreness on her arm and rashes starting to spread all over to her body after the vaccine. Outcome of the events going crazy and little soreness on her arm was unknown while not recovered for the other events. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | pain in extremity |
left arm sore; left arm has a large lump like a 50 cent piece; left arm itching; This is a spontaneo...
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left arm sore; left arm has a large lump like a 50 cent piece; left arm itching; This is a spontaneous report from a contactable consumer (patient reported herself). A 75-year-old female patient received BNT162B2 (Pfizer Covid shot, Formulation: Solution for injection, Batch/lot number: Not Provided, Expiry Date/NDC number: Not Provided) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm sore, left arm has a large lump like a 50 cent piece and left arm itching. Caller stated that she received her first shot on 25Jan2021 and that her arm was sore which went away in a few days. Stated that she received the second shot early on 09Feb2021 because she was scheduled to have surgery. Stated that the spot where she received it is sore, has a large lump like a 50 cent piece and is itching. Stated that she went to the doctor and he put her on Benadryl and Zyrtec over the counter for allergies. Wanted to know if it will be safe to go and have surgery if she had this going on. Stated it was sore and she had terrible itching. Wanted to know if she was on the right track. Stated that she would start testing for surgery on Monday. Wanted to know Pfizer's opinion and if had others are calling with same. Clarified that it was for the left arm for both shots. Clarified that it was for Pfizer Covid shot. Outcome of the events was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-03-30 | feeling hot |
no arm pain at injection site until following morning; my face became warm and beet red; my face bec...
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no arm pain at injection site until following morning; my face became warm and beet red; my face became warm and beet red; experienced incredible thirst; intermittent nausea and lethargy; intermittent nausea and lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient (non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, in Arm Left on 02Feb2021 12:00 (12:00 PM) (age at vaccination 75 Years) as single dose for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin, NSAIDS, doxycycline, lidocaine and prednisone. Concomitant medication(s) included atorvastatin at 10 mg; calcium citrate (CITRACAL [CALCIUM CITRATE]); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]); ubidecarenone (COQ-10) and Magn (as reported). Pateint reported that "on 02Feb2021 at 12:00 PM, Shortly after receiving first dose my face became warm and beet red, didn't realize until I'd gotten to my car and taken off my mask, at which time I also experienced incredible thirst. Other symptoms that day (02Feb2021), Wednesday and today have been intermittent nausea and lethargy, no arm pain at injection site until following morning (03Feb2021), okay now." No treatment was received for the events. This case is reported as non-serious. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome "no arm pain at injection site until following morning" was recovered while other events was recovering. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-04-04 | weakness |
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised ...
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Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
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| 75 | 2021-04-16 | one side paralysis, slurring, inability to speak |
resident turned on call light, emesis X1 right sided weakness, slurred speech. Emesis X1 when EMS at...
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resident turned on call light, emesis X1 right sided weakness, slurred speech. Emesis X1 when EMS at facility Sent to ER 3/5/2021I63.532: CEREB INFRC D/T UNSP OCCLS OR STENOS OF LEFT POST CEREB ART, N31.9: NEUROMUSCULAR DYSFUNCTION OF BLADDER, UNSPECIFIED, R47.01: APHASIA, Z86.16: PERSONAL HISTORY OF COVID-19 3/8/2021 J44.9: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED
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| 75 | 2021-04-17 | weakness |
Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't mo...
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Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't move/tiredness; weakness; bleeding; Test: Iron; Result: Critically low; red blood cell was below 5; administered at the left upper forearm; This is a spontaneous report from a contactable nurse (patient) via Pfizer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left upper forearm on 01Mar2021 at the age of 75-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy (in a grocery store). The patient had no prior vaccinations (within 4 weeks). The patient's medical history included retired (retired registered nurse), ongoing depression (has had this condition for probably 20 years), ongoing lung cancer (has had this condition for probably 3 years), ongoing bipolar (has had this condition for about 4 years), ongoing emphysema (has been severe for about 4 or 5 years), and ongoing chronic obstructive pulmonary disease (COPD) (has been severe for about 4 or 5 years). Concomitant medications included duloxetine taken for depression from an unspecified start date and ongoing (been taking this probably for 15 years); and arformoterol tartrate (BROVANA) (started taking this probably 5 years ago), budesonide (started taking this probably 5 years ago), tiotropium bromide (SPIRIVA) (has been taking this for probably about 4-5 years), oxygen (has been using this full time for 3 years), and Trilogy machine (she sleeps with this, it is an invasive intubation. She puts a big mask on and it pumps air in, pulls air out, letting her lungs rest. Her oxygen hooks up to it), all taken for emphysema and COPD from an unspecified start date and ongoing. The patient reported that she received the vaccine on 01Mar2021 and sometime in Apr2021 around Easter, she went to the hospital for COPD exacerbation, tiredness and weakness. The patient required a visit to the emergency room due to the events and reported that she went by ambulance to the hospital. The patient stated that she has these events often and it has nothing to do with the COVID vaccine. She went to the hospital with exacerbation of COPD and missed her date to get her last shot. She wanted to know whether she can get the 2nd dose of the vaccine with her experience after the 1st dose. The patient reported that she now weighs 177 after she has been pumped full of cortisone. The patient reported that her lung doctor was really the one that manages her medical. The patient reported that she thinks she came home from the hospital the day before Easter and she was in the hospital for 5 days (in Apr2021). She was sick before that, at home, and she finally had to call # to come and get her. She believes she had to call # the 5th day before Easter, but she was not positive. When asked to clarify what she meant by sick, the patient explained she was extremely tired, she couldn't get out of bed and couldn't move. She was having trouble breathing. She was on oxygen 24/7 and sleeps with a trilogy machine so she was having a lot of trouble, it was awful. She said she then found out at the hospital her red blood cell was below 5 and her iron was critically low. They had to give her 2 units of blood and an infusion. Then she went back yesterday and got another infusion and she has to go back next week for another infusion. The patient confirmed that she was hospitalized for COPD. She then stated she didn't know the exact date of when she was discharged from the hospital, but she was thinking it was the day she was scheduled for her second shot. She then clarified she came home Easter. The patient reported that she can't do much without having to sit down, catch her breath, and rest a little bit. She was improving but not as fast as she'd like to. While reading the vaccine record card, the patient stated "my eyes aren't as good as they used to be". Her pulmonologist stated she was going to die if she doesn't take the vaccine. If she catches COVID she was not going to make it, so her pulmonologist thinks her chances are better with the vaccine than without it. The patient said she goes all the time to the hospital; therefore, she doesn't think the events were related to the vaccine. She had been sick several times. They can't do anything about the bleeding, they can't go in to do anything because of her lungs, her lungs were so bad. No further details were provided regarding the bleeding she was speaking of. The patient reported that duloxetine doesn't come as 90 mg so she takes a 30 mg and 60 mg tablet; she mixes the Brovana and Budesoind and takes them at the same time, twice a day. She was given an albuterol solution, 0.5mg PRN (as needed), for her emphysema/COPD. She says she just started taking this from her last hospital stay. The patient reported that she did not remember her iron count, just that it was critically low. She did remember asking the nurse what could happen, and the nurse said a lot of things such as infection. She confirmed tests were done in regards to the lung cancer. Her lungs were too critical for any kind of invasive tests. It was reported that the events Exacerbation of COPD and "extremely tired, couldn't get out of bed, couldn't move" were assessed by the patient as unrelated to BNT162B2. The outcome of the events "Exacerbation of COPD/having trouble breathing" and " extremely tired, couldn't get out of bed, couldn't move/tiredness" was recovering, while the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, the reported events Chronic Obstructive Pulmonary Disease, Fatigue, Asthenia, Blood iron decreased, Red blood cell count decreased and Asthenia are assessed as intercurrent medical conditions and unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-04-17 | numbness, pain in extremity |
Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's. That resulte...
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Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's. That resulted in cervical C3 thru C7 epidural mass. Hemilaminectomy for evacuation of hematoma on 3-17-2021. C5-C6 discectomy anterior cervical w/ fusion 3-18-2021. Resulting complications were unexplained atrial fibrillation 3-21-2021, Ongoing rehab appointments for right arm and leg numbness.
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| 75 | 2021-04-17 | pain in extremity |
Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really so...
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Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-04-17 | feeling hot |
cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swolle...
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cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swollen; arm swelling; bursitis; Muscle pain; joint pain in elbow; the bruise have been flamed; Feeling hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 75-years-old, via an unspecified route of administration in right arm on 13Mar2021 at single dose for COVID-19 immunization. Medical history included diabetic type 2 for probably 13-14 years, sleep apnea for 20 years (2001), arthritis in 2005 (probably 12-14 years), and blood pressure abnormal (reported as blood pressure). Concomitant medications included metformin, sertraline, alprazolam, sitagliptin (JANUVIA), oxybutynin, insulin glargine (LANTUS), lisinopril for blood pressure abnormal (reported as blood pressure), and cortisone for arthritis. The patient received the vaccine on 13Mar2021 in the afternoon and within 24 to 30 hours, the next day (14Mar2021), her right arm, where the vaccine was administered turned all red and swollen and her elbow also hurt. She went to the emergency room because she felt it was a reaction to the vaccine. They told her that it was a bacterial skin infection, an adverse effect of an initial encounter to the vaccine, arm swelling and bursitis caused by that, muscle pain and join pain in elbow and then she guessed it was like cellulitis. They gave her ROCEPHIN at the emergency room and then a couple days later, it wasn't getting any better and it was all the way down to her wrist. She went to immediate care center and received an antibiotic. She was also given 2 more prescription of antibiotics and told that it had to be administered with the antibiotics to get rid of the reactions. It has finally pretty much cleared up with the antibiotics if they hadn't put her in an immediate care and put her on intravenous medications. They were really concerned because it was going to get into sepsis or something. At first, the patient thought that it was just inflamed, then it was skin infection and then adverse effect from the initial encounter of the vaccine. She had been on the antibiotics for 10 days when it finally cleared, but the elbow was still sore and it hurts a lot, but the fluid was drained by an orthopedic doctor. She was given 2 different types of antibiotics plus a shot into her buttocks. It's a little sore because she was informed that "the bruise have been flamed" on Mar2021. When she went to emergency, first they give her 1 gm ROCEPHIN and then switched antibiotic to DURICEF and to BACTRIM DS, and advised to continue monitoring and if swelling and redness was progressive or worse, then go to emergency room again. She went to emergency room on 16Mar2021, the medicine given was doxycycline and then she was seen by an orthopedic physician today where the fluid was drained from her elbow but swelling and redness was progressively getting worst and she was feeling hot on Mar2021. So, she went to the immediate care. Overall, consistent to cellulitis of right upper arm strongly includes to go to the ER but the patient had something else and had to go right then. And then, she was given 1 gm ROCEPHIN and then switched to DURACEF and BACTRIM. She came back to the ER on the same day. It was kind of 2 things, like the redness and skin infection which currently was cellulitis. Doxycycline was what they told her to get, that's what they gave her at the emergency room, doxycycline hyclate. And then said to follow-up with her primary care which she did and that was on 17Mar2021. She looked at it and then they told her to see an orthopedic surgeon and she saw him on the 18Mar2021. They just thought that the antibiotics, that's why he gave her 2 different prescriptions plus the shot in the buttocks because he said if this will not be cured with the antibiotics, she'll end up in a hospital. And then it was raft and it took her 10 days to recover. And he marked little black dots to show where wasn't and if it goes beyond that then call us because it was spreading. The outcome of the events bruise and feeling hot was unknown, not recovered for joint pain, and recovered on 24Mar2021 for all other events. The events required emergency room visit/ physician office visit.
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| 75 | 2021-05-05 | electric shock sensation |
FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHIL...
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FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHILE HOLDING A PLATE THAT DID NOT BREAK. REPORTS SLIGHT RIGHT SIDED HEADACHE DESCIRBED AS ELECTRICTY ONLY. NO CONFUSION. NO SPEECH CHANGES. WAS READING WSJ OUTLOUD TO DETERMINE. I ADVISED HER TO GO TO THE NEAREST EMERGENCY ROOM FOR EVALUATION AS I COULD NOT ATTRIBUTE HER SYMPTOMS TO VACCINE ADR. RESTING IN BED TO HELP ALEVIATE SYMPTOMS. NO MEDICATIONS. 5/2-Called the home and there was no answer, 2nd attempt. Message was left to call the Covid hotline for further follow up.
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| 75 | 2021-05-07 | pain in extremity, feeling hot |
Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side ...
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Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side from her foot to her neck; Sore Left Arm; Chills; Wasn't feeling herself; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; This is a spontaneous report received from a contactable nurse (Patient herself). A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via unknown route of administration on 03Apr2021 (Lot Number: ER8729, Expiry date: Jul 2021) as single dose for COVID-19 immunization. The patient medical history was breast cancer. The patient historical vaccine included BNT162B2 on (LOT:EJ1686 Expiration: 31MAR2021) on 13 Mar 2021 for COVID-19 immunization. The patient had no family history. The patient concomitant medications were not reported. The patient experienced chills on 04Apr2021, sore left arm on 13Apr2021, Rash on the left side of her face; itchy; face felt like it was hot on Apr2021, chills on her left side from her foot to her neck: on 17Apr2021, Tiredness on an unknown date and tightness in her left leg that felt like a tunicate was left on 17Apr2021, wasn't feeling herself Apr2021. The patient stated she wanted to send pictures of her rash on her face that her dermatologist diagnosed last Tuesday as a Covid Vaccine side effect. She had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. They were both done at (withheld). With the first, she had no side effects, other than a sore left arm. The second she had a sore arm and a couple of chills at first. Then two weeks post second vaccination she wasn't feeling herself, and she went to see a primary about that, but that wasn't a definite that it was side effects from the vaccine. Then, the following week on a Thursday she got a rash about the same time but it was getting itchy so she decided someone should look at it. At first she thought it was from her mask, but it was only on the left side of her face. Caller states she wrote a message to her doctor about not feeling well but she didn't connect all of the other symptoms. She went to her primary for the chills on her left side from her foot to her neck and just not feeling like herself. She had a tightness in her left leg that felt like a tunicate was left on. Her face felt like it was hot. States it was really very weird and she was very tired. The tiredness comes and goes. States she was doing interviews yesterday for a long time, virtual interviews and by 12 noon she felt so tired and took a nap and felt out of sorts. She Didn't show her the rash because she thought it was just from her mask and she wasn't a dermatologist. Didn't mention it to her primary. States she tried to cancel the appointment but said she needed to come see her anyway. Thursday she had another appointment so she called the dermatologist when it started to itch and she said to the office, should she be worried. At first, said no time, and reported to doctor and fit her in at 13:30 and she looked at it and said it is really impressive for being 2 weeks old and thinks it is Covid vaccine related. Didn't know if she should report it or not. Maybe it is something. Was thinking the Covid rash was extensive. She still has the tiredness. It reminds her of the tiredness she had after radiation for breast cancer. States it wasn't during the radiation, but 4-5 weeks later and lasted about a month. States the tiredness is not from a lack of sleep, it is like a veil comes over her. States if she has taken 10 naps in her whole life, that is a lot for her and that didn't help. Treatment: Gel for the Rash; states for her leg issue the doctor ordered an MRI to rule out a back or disc problem. States she didn't put it together, one said it might be and another side not sure. At first she was offered the Moderna and she changed when they offered the Pfizer, because of the breast issues from the Moderna. Curious to see at some point if point if other people are experiencing rashes on their faces. Caller states she didn't know what type of rash was common, she assumed it was more of a bodily rash. Tetanus back in the Fall or maybe July thinks last July, she had GI stuff and her physician wasn't particularly believing it was from that. The event tiredness wsa assessed as serious (Medically significant), and tightness in her left leg that felt like a tunicate was left considered serious (Disability). The all other events were assessed as non-serious. The patient had physicians room visit (PCP and dermatologist) and not had emergency room visit. The causality assessment was unknown for all events. The outcome of the event rash on the left side of her face; itchy; face felt like it was hot and tiredness was not recovered, The outcome of all other events was recovered. Additional information requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-05-07 | tingling, numbness |
rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in...
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rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in her throat one side, injection on the right side, just in the right peritonsillar fossa; very foggy; trouble sleeping; numbness; paresthesia; Shingles; Rash around her eye; Sore throat; Earache; This is a spontaneous report from a patient. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN6201) as a single dose (at the age of 75 years) for covid-19 immunization. The patient's medical history included lung Cancer from Aug2010 to Oct2010 (lung cancer survivor and had 35 days of treatments, 20Sep2010 was her last day of treatment. She says the end date for this condition was mid Oct2010, she has inoperable lung scarring, it's not COPD, more like a seasonal allergy, when she runs into an URI they up the prednisone to stop the spasms. She clarifies that URI stands for upper respiratory infection; ongoing sleep obstructive sleep apnea (patient uses a CPAP. She says she has had this condition prior to 2010, since the early 2000's), polymyalgia rheumatica from 2019 and ongoing,ongoing hypothyroidism (had this condition for 30 years probably) , hypertension from Feb2021 and ongoing; gastrooesophageal reflux disease (since the 1990's), chemotherapy and radiation (chemotherapy and radiation 10 years ago), postmenopausal and inoperable lung scarring from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE) taken for polymyalgia rheumatica from; budesonide, formoterol fumarate (SYMBICORT) taken for lung neoplasm malignant; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for lung neoplasm malignant; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease; levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for postmenopause from an unspecified start date and ongoing; ascorbic acid (VIT C) taken for postmenopause; hydrochlorothiazide (HYDRODIURIL) taken for hypertension from Feb2021 to an unspecified stop date. The patient received the first dose of BNT162B2 (lot:EL9262) in the left arm on 21Jan2021 at the age of 75 years for Covid-19 immunization. The patient experienced shingles, rash around her eye, sore throat, earache on 29Mar2021; numbness, paresthesia and trouble sleeping on 31Mar2021; very foggy on 03Apr2021; very foggy was reported as worsened/ trouble sleeping was reported as worsened, rash on her scalp, flat macular rash, on her scalp the vesicles were breaking out basically, pain in her throat one side, injection on the right side, just in the right peritonsillar fossa on an unspecified date. It was further reported that 5 and a half weeks later (after the vaccine) she developed shingles. She said it just recently came to her attention and might be related to the vaccine, but she was not sure if it was or not. She said she has not had the shingles vaccine, she had chemotherapy and radiation 10 years ago and never had any issues so she never got the vaccine for shingles. Patient is on a dose of gabapentin 800mg for the shingles, she has had a lot of difficulty with the dose and the shingles, She said she was little bit fuzzy, but that's probably because of the gabapentin, not the vaccine. Patient also mentioned she had a sore throat, it involves the right forehead, scalp, neck, she has an earache. She said the earache and the sore throat have passed but she still has the issue around her eye, a rash. She said the numbness and paresthesia started, she didn't pay much attention to it, then 2 days later she thought she should see the doctor. She says she saw a rash on her scalp, she didn't see the vesicles right away, she saw a flat macular rash. She says on her scalp the vesicles were breaking out basically. She says the sore throat has been interfering with her sleep, she can't use her CPAP, it got to disabling because she can't use her CPAP. She was very foggy. Trouble sleeping was medically significant moving into disabling because she was really foggy, more foggy as she goes along. She says the foggy is medically significant moving towards disabling, that up until today it was medically significant. She said for her throat she had to gargle a lot, it didn't go away with Tylenol. Tylenol NDC, lot, and expiration date not provided. She says the earache was there, it was annoying. She said the trouble sleeping was related to the shingles, she can't say the vaccine did it. The patient underwent lab tests and procedures included bloodwork on 02Apr2021 and everything came back normal. She said that was to test her kidney function following the HydroDiuril. She said the HydroDiuril was changed from 25mg to 12.5mg. She says she also had a screen of her inflammation markers of her lungs and that that was normal. She says both tests were done on 02Apr2021, that was the last ones, not the first ones done. The patient went to her doctor and ophthalmologist and was prescribed Valtrex. She does not know the dose and frequency, she says it is an antiviral for shingles. She says the gabapentin was for the pain for the paresthesia. The gabapentin was fluctuating, they keep increasing it due to discomfort, and she was up to 800mg in divided doses. She said she also was given eye drops, triple antibiotic polymixin. She had neomycin and another one, that it was the same as the ointment triple antibiotic for abrasions. She used that 3 times a day in her right eye. She also took a cortisone preparation eye drops and that they are also 3 times a day in her right eye. She says her ophthalmologist put her on a second course of Valtrex, she does not know the dose or frequency, saying that it varies according to her primary care physician. She says the total is 800 mg in divided doses. She says she is doing 200, 200, 400, she is trying to get off of it but that doesn't work so they are going to be increasing it. The organ involvement included respiratory and Dermatological/Mucosal. The patient was recovering from the events shingles and rash around her eye, recovered from sore throat, earache on 19Apr2021, not recovered from the events numbness, paresthesia, very foggy, trouble sleeping, and unknown outcome for all the other events.
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